Blister cards promoting intuitive dosing

Technical field

The present invention generally relates to blister cards, and more particularly to blister cards supporting intuitive dosing.

Background of the invention

Many treatment regimens recommend taking different unit doses at different times of the day and / or on specific days. These doses may require administration at different times of the day or under different conditions, for example, fasting compared to administration after a meal. In addition, when the unit dose is to be given at certain times of the day, you may have difficulty remembering when to take the unit dose. Therefore, compliance with such therapeutic programs is a problem.

Many types of packaging and unit dose dosing kits have been developed. Such kits include those developed for dosing active ingredients at a constant frequency once a day. See, e.g., US Patent No. 5,265,728, to Allendorf et al., Issued November 30, 1993; publication EP 0 511726 A2, to the company Berlex Laboratories,

Inc., published November 4, 1992; PCT publication WO 99/51214, to Akzo Nobel, published on October 14, 1999; and US Patent No. 4,958,736 to Urheim, issued September 25, 1990, which describe dispensers for the administration of various pharmaceutical agents, including oral contraceptives, on a daily basis, including regimens in which the active ingredient is administered daily for approximately 21 days, followed by placebo for approximately seven days. Other kits and dispensers have been developed that are intended for multiple doses of the same active ingredient per day, or for simultaneous or non-simultaneous administration of two or more active ingredients.

See, e.g., US Patent No. 6,024,222, to Friberg et al., Issued February 15, 2000; U.S. Patent No. 6,219,997 to Friberg et al., issued April 24, 2001; United States Patent Publication 2003/0168376 A1, Taneja et al., published September 11, 2003; United States Patent Publication 2003/0111479, Taneja et al.,

EP2 651 365 published on June 19, 2003; U.S. Patent No.

6,375,956, to Hermelin et al., Issued April 23, 2002; PCT publication WO

88/02342, Astra Lakemedel Aktiebolag, published April 7, 1988; patent

United States No. 4,295,567, issued to Knudsen, issued

twenty October 1981; publication DE 29719 070, to the company Byk Gulden Lomberg Chemische Fabrik, published June 25, 1998; U.S. Patent No. 5,848,976 to Weinstein, issued December 15, 1998; U.S. Patent No. 6,270,796 to Weinstein, issued August 7, 2001; U.S. Patent No. 6,564,945 to

Weinstein et al., Published May 20, 2003; and US Patent No. 5,788,974 to D'Amico et al., issued August 4, 1998. A kit for administering the active ingredient once weekly is also disclosed. See United States Patent Publication 2001/0044427, Mazel et al., Published November 22, 2001.

US 2005/0150806 discloses a drug distribution system for packaging drugs as directed, designed to contain unique daily drugs and supplements for each person and improve timely drug delivery.

summary

The present invention is defined in accordance with the appended claims. In one example, the daily blister card containing the unit dose comprises a back side and a front side opposite the back side. The front side has a face. No less than four and no more than five blisters protrude from the frontal surface. Each blister contains a unit dose. The manufacturer's mark is visible on the front. One unit dose in one of the blisters is different from another unit dose in the blisters.

In another example, the daily blister card containing the unit dose comprises a back side and a front side opposite the back side.

The front side has the manufacturer's mark visible on the front side. The frontal surface has an outer periphery and an entire flat area surrounded by an outer periphery. One or more blisters that contain at least three unit doses that are visible from the outside of one or more blisters protrude from the front surface. Each

EP2 651 365 of one or more blisters includes a bead in contact with the support surface of the chamber and a protruding area of ​​the chamber surrounded by a protuberance which projects on the support surface of the chamber. The entire projecting area of ​​the chamber of one or more blisters is not larger than about

45 percentage of the entire flat area surrounded by the outer periphery.

In another example, the daily blister card containing the unit dose comprises a back side and a front side opposite the back side. The front side has a face. At least three blisters protrude outwards from the front surface. Each of at least three blisters contains a unit dose. Unit doses in at least three blisters are arranged in a sequential directional dosage system. The manufacturer's mark is visible on the front. One unit dose in one of the blisters is different from another unit dose in another of the blisters.

In another example, the daily unit dose blister card contains the back with the unit dose information thereon. The unit dose information contains legal information. The front side is opposite the back side. The front side has a face. At least three blisters protrude outwards from the front surface. At least three blisters contain a unit dose that is visible from the outside of at least three blisters. The manufacturer's mark is visible on the front. One unit dose in at least three blisters is different from another unit dose in at least three blisters.

In another example, a method of receiving unit doses as directed within 24 hours is provided using a daily unit dose blister card. The method includes folding a diurnal blister card comprising a back side and a front side opposite the back side. The front side has a face. No less than four and no more than five blisters protrude from the frontal surface. Each blister contains a unit dose. The manufacturer's mark is visible on the front. One unit dose packaged in one of the blisters is different from the other unit dose in another of the blisters.

In another example, a method of receiving unit doses as directed within 24 hours is provided using a daily unit dose blister card. This method includes

EP2 651 365 folding of a daily blister card containing the back side and the front side opposite the back side. The manufacturer's designation is visible on the front side. A frontal surface with an outer periphery and an entire flat area surrounded by the outer periphery shall be provided. One or more outer blisters that form at least three unit doses that are visible from the outside of one or more blisters are formed on the front surface. Each of the one or more blisters comprise a bead and a protruding area of ​​the chamber surrounded by a bead that protrudes onto the bearing surface of the chamber. The entire projecting area of ​​the chamber of one or more blisters is not more than about 45 percent of the entire flat area of ​​the frontal surface surrounded by the outer periphery.

In another example, a method of receiving unit doses as directed within 24 hours is provided using a daily unit dose blister card. The method includes folding a diurnal blister card comprising a back side and a front side opposite the back side. The front side has a face. At least three blisters protrude outwards from the front surface. Each of at least three blisters contains a unit dose. Unit doses in at least three blisters are arranged in a sequential directional dosage system on the frontal surface. The manufacturer's designation is visible on the front side. One unit packet contains one unit dose, which differs from the other unit dose in another unit.

In another example, a method of receiving unit doses as directed within 24 hours is provided using a daily unit dose blister card. The method includes folding a diurnal blister card containing the back side with unit dose information thereon, including legal information, and the front side opposite the back side. The front side has a face. At least three blisters protruding outwardly are formed on the frontal surface. At least three blisters contain a unit dose that is visible from the outside of at least three blisters. The manufacturer's designation is visible on the front side. One unit dose in at least three blisters is different from another unit dose in at least three blisters.

EP2 651 365

Short description of the drawings

The following detailed description of specific embodiments of the present invention may be best understood in conjunction with the drawings attached to this description.

FIG. 1 illustrates an embodiment of a unit dose dosing system;

FIG. 2 illustrates a front view of an embodiment of a blister card for use with the unit dose dosing system of FIG. 1;

FIG. 3 is a side view of the blister card of FIG. 2;

FIG. 4 is a cross-sectional view of the blister area along line 4-4 of FIG. 2;

FIG. 5 is a front view of the blister card of FIG. 2 with the blister leaf removed;

FIG. 6 shows another front view of the blister card of FIG. 2 with the blister leaf removed;

FIG. 7 is a front view of an embodiment of a blister strip;

FIG. 8 is a rear view of the blister card of FIG. 2;

FIG. 9 shows another embodiment of a blister card;

FIG. 10 shows a side view of the blister card of FIG. 9;

FIG. 11 is a rear view of the blister card of FIG. 9;

FIG. 12 is a front view of another embodiment of the blister card;

FIG. 13 is a front view of another embodiment of the blister card;

FIG. 14 is a front view of another embodiment of the blister card;

FIG. 15 is a front view of another embodiment of the blister card; and

In another example, a single daily blister card may contain a plurality of doses that are taken entirely throughout the day, as indicated in the instructions on the package. In one example, the doses are taken within 8 hours, in another example the doses are taken within 12 hours, in another example the doses are taken within 16 hours.

EP2 651 365 hours, in another example the doses are taken within 18 hours and in another example the doses are taken within 24 hours.

The term "unit dose" or "unit dosage" means a dosage form containing the amount of active substance or nutrient that is preferable for administration in one single dose, in accordance with accepted medical practice.

The term "active substance" as used herein includes all compounds and compositions that can be used in the treatment and / or prevention of colds / flu and / or to provide general health and care benefits in mammals. Non-limiting examples of particularly useful active ingredients include over-the-counter and prescription active substances, vitamins, minerals, elements, plant-derived substances, energy-stimulating substances, probiotics, fiber, prebiotics and combinations thereof. The active substance is the active substance for multi-symptomatic (MSR) treatment of cold / flu.

The term "daily" as used herein means a unit dose that is generally taken during the day. The daily unit dose contains phenylephrine or pseudoephedrine.

The term "nocturnal" as used herein means a unit dose that is generally taken at bedtime or around the time of sleep. The nightly unit dose contains doxylamine succinate.

As used herein, an "assay" provides information for a potential user or user of systems, dosage units (e.g., the active substance contained therein) and blister cards. The assay may include many forms and present information in many ways and in many types of media. Non-limiting examples of types of markings include alphanumeric markings, photos, drawings, illustrations, photographs, computer images, colors, sounds, textures, shapes, symbols, letters, numbers and combinations thereof.

"Blister cards" are for unit dose packaging. Generally, blister cards usually include a front side, which is the side that contains one or more blisters, and an opposite back side through which the unit dose is removed from the blister.

EP2 651 365

Blister cards can take any different shapes, such as rectangular, rounded, such as round etc.

The "face" of the blister card refers to one or more visible surfaces on the front side of the blister card.

The term "blister" refers to a sheath formed by an outer layer that is raised on the end face, thereby forming a chamber for receiving a unit dose.

The term "legal information" generally refers to information that a governmental body, such as the Agency, requires to be included with the product

Food and Drug Administration (FDA) of the United States. The regulatory information on unit doses may include ingredients; warnings, if any; dosage tips; name of the producer or distributor; batch number; the term of validity; instructions for opening or access (e.g. in the case of child-resistant packaging); and a statement of all safeguards against opening.

The term "adherent" as used herein means in real contact.

The term "daily" in the context of the unit dose regimen described herein refers to the administration of multiple doses of the same or different ingredients on the same day or over 24 hours. For example, a single daily blister card may contain multiple doses to be taken. all in the same 24-hour period.

The term "unit dose" or "unit dosage" means a dosage form containing the amount of active substance or nutrient that is preferable for administration in one single dose, in accordance with accepted medical practice.

The term "active substance" as used herein includes all compounds and compositions that can be used in the treatment and / or prevention of disease and / or to provide general health and care benefits in mammals. Non-limiting examples of particularly useful active ingredients include over-the-counter and prescription active substances, vitamins, minerals, elements, plant-derived substances, energy-stimulating substances, probiotics, fiber, prebiotics and combinations thereof.

EP2 651 365

As used herein, an "assay" provides information for a potential user or user of systems, dosage units (e.g., the active substance contained therein) and blister cards. The assay may include many forms and present information in many ways and in many types of media. Non-limiting examples of types of markings include alphanumeric markings, photos, drawings, illustrations, photographs, computer images, colors, sounds, textures, shapes, symbols, letters, numbers and combinations thereof.

Referring to FIG. 1, one exemplary embodiment of a unit dose dosing system 10 includes a container 12 (e.g. a box) that houses a plurality of blister cards 14. For example, each blister card 14 may contain a plurality of unit doses 13 and 15 to be taken in its entirety daily (i.e. during 24 hours). Therefore, blister cards 14 may be referred to as daily blister cards. The consumer using the unit dose dosing system 10 may daily remove the blister card 14 from the container 12 and carry the blister card 14 to take the unit doses accompanying the blister card 14.

In some embodiments, the unit dose 13 may be different from the unit dose 15. For example, the unit dose 13 may contain or have another active substance, different filling (e.g., different amounts of active substance), different color, different marking, different size and / or a different shape from the unit dose 15. Unit doses 13, for example, can be administered over the course of the day when a sedative effect is not desired. A unit dose, for example, can be administered at night when a stimulant effect is not desired. The unit dose 13 may contain an antihistamine and / or anti-edema agent without sedation, but not an antihistamine with sedation. The unit dose may contain an antihistaminic agent having a sedative or non-sedative effect, but not a vasoconstrictor with a stimulant effect. Of course, other active ingredients are possible, some of which are shown below.

Blister cards 14 may contain information that helps the consumer understand how (e.g. when) the unit doses 13 and 15 carried on blister cards 14 should be taken. Referring now to FIG. 2 and 3

EP2 651 365 showing separately the blister card 14, the blister card 14 generally comprises a front side 16 and a back side 18 opposite the front side 16.

Referring in particular to FIG. 2, the front side 16 includes a face 20 that is visible to the consumer with an outer rim 22. The entire flat area of ​​the front side 16 is defined by the outer rim 22 (e.g., width of the front side multiplied by the height of the front side in the case of a rectangular blister card). The blister leaf 24 extends over at least part of the face 20. In the embodiment shown, the blister leaf 24 extends only over part of the face 20, while in other embodiments the blister leaf 24 can extend over most of the face 20, e.g. the entire face 20. Blister strip 24 contains a plurality of visible areas of blisters 26, 28 and 30, each of which includes blister 34, 36 and 38 extending outwardly to face 20, and areas of beads 42, 44 and 46 surrounding their individual blisters 34, 36 and 38 .

Areas of the beads 42, 44 and 46 may be used to attach or attach the blister strip 24 to the front face 20. Each of the blisters 34, 36 and 38 forms a chamber 50, 52 and 54 in which one or more unit doses ( e.g. in the form of tablets, capsule forms, liquid forms).

In some embodiments, each blister area 26, 28 and 30 may include a perforated edge 57 (or other line of weakness) that allows a specific blister area 26, 28 and 30 to be removed from the blister card 14. In the corners of the blister areas 26, 28 and 30, there may be indentations 59 that can be used to round the corners, such that, for example, when the blister area 26, 28 and 30 is torn away from the blister card 14, a relatively rectangular, sharp corner is not formed. Indents 59 can also serve as a visual demarcation of different areas of blisters 26, 28 and 30.

The front side 16 includes two or more major reference areas 58 and 60. In the embodiment of FIG. 2, the major designation area 58 may be the manufacturer's main designation area, and the main designation area 60 may be the main unit dose designation area. The manufacturer's main area 58 may extend continuously on the front face 20 of the front side 16, may be free of any blister packs and unit doses, and may contain at least one manufacturer's designation 62, such as logo, image, manufacturer's name, etc., in order to

EP2 651 365 providing the consumer with the manufacturer's designation or source of blister card 14. Generally, the term "manufacturer's major area" refers to the area of ​​the front face 20 comprising at least one manufacturer's designation 62 and not containing a blister or unit dose.

The main unit dose designation area 60 may correspond to the area occupied on the front surface 20 of the front side 16 by the visible areas of the blister pack 26, 28 and 30, in the blister pack 24. In some embodiments, the main unit dose designation area 60 includes two or more unit dose information subsections 64 , 66 and 68.

Each sub-dose information sub-area 64, 66 and 68 may be visible to the consumer and may include an information sign (not shown in FIG. 2) that indicates the time of day at which the unit dose accompanying the sub-dose information sub-area 64, 66 and 68 is to be taken. .

In the embodiment of FIG. 2 blister card 14 has a horizontal or long axis A1 running along the width of blister card 14 and a vertical or short axis A2 running along the height of the blister card 14. The term horizontal and vertical refers to the situation when the face 20 is in a vertical position with the manufacturer's mark 62 in the vertical arrangement shown. As can be seen, the main area of ​​the manufacturer's designation

58 extends continuously from the main unit dose designation area 60 along the height (i.e. towards the vertical axis A2) to the upper edge 72 of the outer periphery 22. The manufacturer's main designation area 58 also extends continuously along the width (i.e. towards the axis horizontal A1) between side edges 74 and 76 of the outer rim

22.

The main unit dose designation area 60 extends continuously from the manufacturer's main designation area 58 along the height (i.e. towards the vertical axis A2) to the lower edge 78 of the outer periphery 22. The main unit dose designation area 60 also extends continuously along the width (i.e. towards the horizontal axis A1) between side edges 74 and 76 of the outer rim 22.

Referring to FIG. 4, a cross-sectional view of a blister card 14 containing a blister 34 without a unit dose 13. In the embodiment shown, the blister card 14 comprises a carrier layer 300, a layer

EP2 651 365 tear 302, blister strip 24 and cover layer 304. In some embodiments, the support layer 300 and cover layer 304 may be formed from the same sheet of material that is folded over the top edge 72 (FIG. 3) of blister card 14 so that at least partially the blister leaf 24 and tear layer 302 are disposed between them. In other embodiments, tear layer 302 and blister leaf 24 may not be sandwiched between carrier layer 300 and cover layer 304.

The blister 34 comprises an outer wall 79 of the blister which defines a chamber 50 between the outer wall 79 of the blister and the support surface 306 of the blister which is formed with the tear layer 302. The bead 83 is the edge on which the outer wall 79 of the blister extends and is not connected to the support surface 306 blister pack. As seen in FIG. 5, the protruding region of the chamber 85 is surrounded by a bead (represented by line 83) in places where the bead extends from the support surface 306 of the blister. The projecting area of ​​the chamber is the contour of the chamber 50 on the support surface 306 of the blister card 14.

Referring to FIG. 5, the blister card 14 is shown with the blister leaf 24 removed to represent the front face 20. The front face 20 includes the manufacturer's main marking area 58, which in this embodiment can be formed by a cover layer

304, and the main unit dose designation area 60, which is adjacent to the manufacturer's main designation area 58. The manufacturer's designation 62 is located in the main area of ​​the manufacturer's designation 58. In some embodiments, the manufacturer's designation area 58 may also contain information or designations other than the designation. manufacturer 62.

The face 20 further includes the main unit dose designation area 60. The main unit dose designation area 60 is divided into a plurality of unit dose information subareas 64, 66 and 68. In the embodiment of FIG. Each of the unit dose information sub-areas 64, 66 and 68 corresponds (e.g., has about the same rim, position and dimensions as) to the respective one of the visible areas of the blisters 26, 28 and 30 (FIG. 2), wherein the visible areas of the blisters 26, 28 and 30 are separated by a weakness line or a tear line 57 (e.g., a perforated or cut line).

The main areas of chambers 85, 87 and 89 are in the information subdivisions of the unit dose 64, 66 and 68. In some examples

EP2 651 365 embodiments no more than about 45 percent of the entire flat area surrounded by the outer periphery 22 is covered by the protruding areas of the chambers 85, 87 and 89.

In some embodiments, no more than about 40 percent of the entire flat area surrounded by the outer periphery 22 is covered with projecting areas of chambers 85, 87 and 89, e.g., about 35 percent or less, e.g., about 30 percent or less, e.g., about 25 percent or less, e.g., about 20 percent or less, e.g., about 18 percent or less, e.g., about 10 percent or less. In some embodiments, the entire flat area surrounded by the outer periphery 22 may not be larger than about

120 cm², for example, no more than about 100 cm², for example, no more than about 80 cm², for example, no more than about 70 cm², for example, no more than about 61 cm², for example, no more than about 50 cm².

In some embodiments, in the case of blister card 14 with an outer periphery of a substantially rectangular shape, as seen in FIG. 2, no more than about 36 percent of the entire flat area surrounded by the outer periphery 22 is covered by the protruding areas of chambers 85, 87 and 89. For example, in some embodiments of the substantially rectangular blister card 14, no more than about 27 percent of the entire flat area surrounded by the outer periphery 22 is covered by projecting areas of the chambers 85, 87 and 89, for example no more than about 18 percent. For other shapes of the outer rim, as will be discussed below, these percentages may be different.

In one embodiment, the projecting areas of ventricles 85, 87 and 89 may include only (i.e., are surrounded by or limited to only) a certain percentage of the projecting dose stroke area 310, 312 and 314. The "projecting dose stroke area" is a unit dose stroke 13 and 15 protruding on the supporting surface 306 of the blister. In some embodiments, each protruding region of chamber 85, 87 and 89 may not be greater than about 100 percent to about 250 percent of the associated protruding dose contour area 310, 312, and 314, for example, from about 100 percent to about 150 percent. In these embodiments, the entire projecting area of ​​the ventricle (i.e., the sum of the individual projecting areas of the ventricles) is only a certain percentage (e.g., from about 100 percent to about 150 percent) of the entire projecting dose contour (i.e. sums of all protruding dose strokes). For these purposes

EP2 651 365 embodiments, as an example of an oversized blister with a total projecting area of ​​the ventricle much larger than the total projecting area of ​​the dose contour, the total projecting area of ​​the ventricle only covers this area from about 100 percent to about 250 percent, for example from about 100 percent to about 150 percent of the total projecting area of ​​the dose stroke.

In some embodiments, a single blister may contain only one unit dose as shown in FIG. 2, or multiple unit doses, as shown in FIG. 9. In embodiments containing only a single unit dose in a blister, the projecting area of ​​the ventricle may not be greater than about 100 percent to about 150 percent of the accompanying projecting dose outline. In embodiments containing multiple unit doses in a blister, the projecting area of ​​the ventricle may not be greater than about 150 percent to about 250 percent of the associated projecting dose outline.

At least some or all of the subdivision unit information subsections 64, 66 and 68 contain information reference 84, 86 and 88, which is visible through blister leaf 24 (e.g., the blister leaf may be formed of transparent or translucent material). In the example of FIG. Each subdivision 64, 66 and 68 unit dose information sub-area has a different color, such as information markings 84, 86 and 88. In some embodiments, the colors of the information subdivisions 64, 66 and 68 can be selected to determine the logical time sequence corresponding to different times of the day. For example, the unit dose information sub area 64 may be pale yellow, indicating morning time, the unit dose information sub area 66 may be yellow-orange, indicating afternoon or evening, and the unit dose information sub area 68 may be blue, indicating the night time.

In some embodiments, unit doses 13 and 15 (FIG.

1) they may have different colors, providing a different information designation for each information subarea of ​​unit dose 64, 66 and 68. For example, each of the unit doses 13 may be yellow and / or yellow-orange, indicating the time of day, and the unit dose 15 may be blue, indicating the time of night. Other color combinations are possible.

EP2 651 365

Each unit dose information sub area 64, 66 and 68 is adjacent to the adjacent unit dose information sub area 64, 66 and 68. In some embodiments, at least some or all of the unit dose information sub areas 64, 66 and 68 have a clearly defined border between adjacent information sub areas unit dose 64, 66 and 68. In those embodiments in which the unit dose information sub area 64, 66 and 68 is indicated by a specific rim or a sudden color change, the unit dose information sub areas 64, 66 and 68 may be referred to as separate (i.e., separate) unit dose information sub areas 64 , 66 and 68.

Referring to FIG. 6, in addition to the color, the subdivision unit information subdivisions 64, 66 and 68 may include other information designations 92 and 94. For example, information designation 92 may be an image of the sun indicating the daytime, and information designation 94 may be the image of the moon indicating the night time. Information designation 92 in the form of the sun may be in whole or at least partially within each of the sub-dose information subareas 64, 66 and 68, while information designation 94 may be in whole or at least partially within the sub-dose information sub-area 68. Information designations 92 and 94 can also be viewed through blister strip 24, and in some embodiments through blisters 34, 36 and

38.

In addition to the images of the sun and moon, other informational signs may contain text, for example, "Morning", "Afternoon", "Evening" and "Night" or other language equivalent. In some embodiments, the informational signs may include other types of images, for example a clock. Time of day can also be associated with each unit dose information sub-area 64, 66 and 68.

In some embodiments, the informational indications may be arranged in a sequential directional dosage system. The term "sequentially directional dosage system" refers to unit doses arranged directionally on a blister card (e.g., from left to right) in ascending order depending on the time of ingestion. For example, a sequential directional dosage system may be a left-to-right time system.

EP2 651 365 and counterclockwise, in which in order to remove the unit doses, the blisters to the left most are first accessed. In another example, the sequential directional dosage system may be a right-to-left clockwise clockwise system in which the rightmost blisters are first accessed to withdraw unit doses. Other systems may be used, such as sequentially directional top-down and bottom-up dosage systems.

Referring now to FIG. 7, the blister pack 24 is shown separately.

The blister leaf 24 contains blister areas 26, 28 and 30, which are separated by tear lines 57. Each blister area 26, 28 and 30 contains one of the blisters 34, 36 and 38 and one of the areas of the beads 42, 44 and 46. Blister leaf 24 it may be connected directly to tear layer 302 (FIG. 4) within the areas of beads 42, 44 and 46. In some embodiments, each blister 34, 36, 38 may have a vertical axis L1 and a horizontal axis L2, e.g. for storing capsule-shaped (oval) tablets. The vertical axes L1 of blisters 34, 36 and 38 can be positioned substantially parallel to the vertical axis A2 of the blister card 14, while the horizontal axes L2 can be positioned substantially parallel to the horizontal axis A1 of the blister card 14. In other embodiments, the vertical axes L1 of blisters 34, 36 and 38 can be angularly shifted from both horizontal and vertical axis A1 and A2 of blister card 14.

Referring to FIG. 8, the back side 18 of blister card 14 is shown, the blister card 14 being rotated about its horizontal axis A1. Information label 96 is printed and visible on the back of blister card 14. Information label 96 may contain legal information, detailed dosage information, information on ingredients, manufacturer's information, warnings, etc. Information reference number 96 containing legal information may relate to one or all unit doses within unit dose information subareas 64, 66 and 68 (FIG. 5). The information reference number 96 containing legal information may be arranged such that the legal information is not destroyed when the unit dose is removed from at least one of at least three blisters from the rear side 18.

Information notices 97, 99 and 101 may also appear on the back side of each of the dose sub-information information sub-areas 64, 66 and 68. In some embodiments, information notifications 97, 99 and 101

EP2 651 365 may be on the rear side 18 to preserve the spatial arrangement of unit dose information subareas 64, 66 and 68 on the front side 16 so that, for example, information designation 97 accompanies unit dose information subarea 64, information designation 99 accompanies information subarea unit dose 66, and the information designation 101 accompanies the unit dose information subarea 68. Maintaining this spatial arrangement allows the taking of information notices 97, 99 and 101 accompanying each unit dose 13 and 15 together with the accompanying information subdivision of unit dose 64, 66 and 68 after removal from blister card 14. This spatial arrangement also allows enough legal information to be left on blister card 14 to comply with the minimum legal requirements provided for in a particular jurisdiction, for example, the US Food and Drug Administration. In some embodiments, the reference signs 97, 99 and 101 may include a drawing of the sub-dose information subdivisions 64, 66 and 68 on the front side 16, which may assist in accessing the target unit dose at a specific time of day. In some embodiments, area 103 may be, for example, an openable door or flap 105 that can be opened or removed to expose the tear layer 302 behind it to remove a unit dose.

As can be seen, reference signs 96, 97, 99 and 101 are upside down relative to the orientation of the manufacturer's designation 62 (FIG. 5). This may prompt the consumer, when viewing the front side 16, to rotate the blister card 14 around its horizontal axis A1 in order to read the information label 96 on the back side 18. In some embodiments, the information sign may also be inverted from left to right or right to left to induce the consumer to rotate the blister card around the vertical axis A2.

The blister card 14 described above has in a sense a rectangular shape with unit dose information sub-areas 64, 66, 68 adjacent and positioned along a common, essentially linear periphery, but other shapes and configurations are possible. Referring to FIG. 9, the substantially round or rounded blister card 100 contains a plurality of unit doses 102, 104 and 106 to be taken in its entirety daily (i.e. during

EP2 651 365 hours). Accordingly, the blister card 100 contains information that helps the consumer understand how and when to take the unit dose worn on blister card 100.

Also referring to FIG. 10 and 11, the blister card 100 includes a front side 108 and a back side 110 opposite the front side 108. The front side 108 includes a face 112 with an outer, substantially circular rim 114 and an entire flat area that is surrounded by the outer rim 114. Blister flap 116 extends over at least part of the face 112. Blister strip 116 contains a plurality of visible areas of blisters 118, 120 and 122, each containing blister 124, 126 and 128 extending outwardly from face 112, and areas of beads 130, 132 and 134 surrounding their individual blisters 124, 126 and 128 The areas of the beads 130, 132 and 134 may be used to attach the blister strip 116 to the tear layer in a manner similar to that shown in FIG. 4. Each of the blisters

124, 126 and 128 form a chamber 136, 138 and 140 in which one or more unit doses (e.g., tablet, capsule, liquid) can be stored.

In some embodiments, each blister area 118, 120 and 122 may include a perforated edge 142 (or other line of weakness) that allows a specific area of ​​blister 118 to be removed,

120, 122 from blister card 100. In the corners of the blister regions 118, 120 and 122 there may be indents 144 that can be used to round the corners so that a relatively rectangular, sharp corner is not formed.

In a similar manner to that described above, the front side 108 includes two or more major reference areas 146 and 148. The main reference area 146 is the manufacturer's main reference area and the main reference area 148 is the main unit dose designation area. The main area of ​​the manufacturer 146 may extend continuously on the face 112 of the front side 108, may be free of any blisters and unit dose, and may contain at least one manufacturer's mark

153, such as the logo, manufacturer's name, etc., to provide the consumer with the manufacturer's designation or source of blister card 100.

The main unit dose designation area 148 may correspond to the area occupied on the front surface 112 of the front side 108 by the visible areas of the blisters 118, 120 and 122 of the blister strip 116. In some

In embodiments, the main unit dose designation area 148 includes two or more sub-unit information sub-areas 152, 154 and 156. Each unit dose information subarea 152, 154 and 156 may be visible to the consumer and may include information symbol 158, 160 and 162, which indicates the time of day at which the unit dose accompanying the unit dose information subarea 158, 160 and 162 is to be taken in a manner similar to that described above, including colors, images, numbers and text.

In some embodiments, in the case of a blister card 100 with an outer periphery of a substantially circular shape, as seen in FIG. 9, no more than about 40 percent of the entire flat area surrounded by the outer periphery 114 is covered by the protruding areas of the blister chambers 124, 126 and 128. For example, in some embodiments of the substantially round blister card 100, no more than about 28 percent of the entire flat area surrounded by the outer periphery 114 is covered by projecting chamber areas, for example, no more than about 18 percent.

The blister card 100, being round, has a horizontal axis A1 running along the width of the blister card 100 and a vertical axis A2 running along the height of the blister card 100. The axes A1 and A2 correspond to the diameter of the blister card

100. The term horizontal and vertical refers to the situation when the face 112 is in a vertical position with the manufacturer's designation 153 in the vertical position shown. The manufacturer's main designation area 146 extends continuously from the main unit designation area 148 along the height (i.e. towards the vertical axis A2) to the upper portion 164 of the circular outer periphery 114. The manufacturer's main marking area 150 also extends continuously along the width (i.e. towards the horizontal axis A1).

The main unit dose designation area 148 extends continuously from the manufacturer's main designation area 146 along the height (i.e. towards the vertical axis A2) to the bottom portion 166 of the outer periphery 114. The main unit dose designation area 148 also extends continuously along the width (i.e. towards the horizontal axis A1).

Referring to FIG. 11, the back side 110 of blister card 100 is shown, the blister card 100 being rotated about its horizontal axis A1. The back side 110 of blister card 100 is printed

EP2 651 365 and information reference 168 is visible. Information reference 168 may contain legal information, detailed dosage information, information on ingredients, manufacturer's information, warnings, etc.

Information designation 168 containing legal information may relate to one or all unit doses within the information sub-areas of unit dose 152, 154 and 156. Information designation 168 containing legal information may be positioned such that legal information is not destroyed when the unit dose is removed from at least one of at least three blisters from the back side 110. Accordingly, information notices 169, 171 and 173 may also appear on the rear side of each of the dose sub-information information sub-areas 152, 154 and 156 to preserve the spatial arrangement of the information dose sub-areas of the unit dose 152, 154 and 156 on the front side 108. Information signs 168, 169, 171 and 173 may also be inverted relative to the position of the manufacturer's designation 153 to induce the consumer, when viewing the front side 110, to rotate the blister card 100 around its horizontal axis A1 or vertical axis A2 to read the information marking .

In some embodiments, such as those described above, the unit dose may be in the form of vertically arranged tablets. In the embodiment of FIG. 2 only shows one tablet 13 or 15 per blister. In FIG. 9 shows more than one tablet 102, 104 and / or 106 (e.g. two tablets) per blister and vertically (i.e. parallel to the axis A2). In some embodiments, there may be more than three blisters per blister card, for example, no less than four to no more than five blisters. Referring to FIG. 12, in an alternative embodiment, the tablets 102, 104 and / or 106 may be arranged offset from the vertical, but may contain many of the elements described above.

Referring to FIG. 13, another embodiment of blister card 180 includes a frangible portion 182 that can be separated along tear line 184 to form a circular blister card 180 similar or identical to blister card 100. In these embodiments, calculations of the entire flat area bounded by the outer periphery may include frangible part 182. In another embodiment, referring to FIG. 14, blister areas 186, 188

EP2 651 365 and 190 of blister card 192 can be stacked vertically. Referring to FIG. 15, in yet another embodiment, the blister areas 194 and 196 of the blister card

198 can be separated from the blister area 201. Folded blister cards can also be provided. Referring to FIG. 16, the blister card 200 may include a fold line 202 that is formed on the molded and / or rear side 204, 206 of the blister card 200 that allows the blister card 200 to be folded in a book-like manner. In these embodiments, the calculation of the entire frangible area surrounded by the outer periphery can be made in the unfolded state of the blister card 200. In these embodiments, no more than about 15 percent of the entire flat area surrounded by the outer periphery may be covered with protruding chambers in the case of a folding blister card 200.

Basically, the systems described above relate to blister packaging, blister card or blister pack, all of which are used interchangeably. Blister cards may have a different desired shape and size depending on the number, size and type of dosage units placed therein, and may have dimensions chosen so that they can be conveniently moved. Non-limiting examples of such shapes include rounded, round, oval, rectangular, square, triangular, trapezoidal, octagonal and combinations thereof. The blister cards can also be formed with elements enabling the separation of one or more parts of the blister cards, i.e. one or more parts comprising the cover. Non-limiting examples of such elements include perforations, cuts and combinations thereof.

Blister packs may contain one or more blister packs on the front side and a tear-off layer on the back side which combination surrounds one or more dosage units. The blister leaf provides envelopes, in any preferred size and / or shape, for one or more dosage units of any preferred size, shape or form. The tear layer allows the dosage unit to be removed from the blister card. The tear layer may be formed on all or part of the blister pack. The tear layer can be attached to the blister strip, for example, by subjecting it to high temperature and pressure, or using glue. Such blister cards may also include a carrier layer that can be placed on or above the tear layer to prevent accidental rupture and release of units

EP2 651 365 dosage. Such a support layer can be torn off to expose the tear layer when it is desired to release the dosage unit. Such support layers may comply with US standards. United States standards on child-resistant packaging can be found in the Code of Federal Regulations, Title 16: Part 1700.

Each blister may contain one unit dose or multiple unit doses. In one example, each blister may contain a unit dose, in another example the blister may contain two unit doses, and in another embodiment each blister may contain more than 2 unit doses. In one example, the blister card may contain 1 blister, in another example 2 blisters, in another example 3 blisters, in another example 4 blisters, and in another example 5 blisters. Each blister may contain one unit dose. In one example, each blister may contain 1 tablet, in another example each blister may contain 2 tablets, and in another example each blister may contain more than 2 tablets. The blister card of the invention contains at least three unit doses.

Users have been found to prefer no more than five unit doses for twenty-four hours of treatment. In one example, the blister card may contain 5 unit doses, in another example 4 unit doses, and in another example 3 unit doses. There may be 4 unit doses and 3 unit doses of daily active substances for multi-symptomatic (MSR) treatment of cold / influenza and 1 unit dose of nocturnal active substances for multi-symptomatic (MSR) treatment of cold / influenza.

In accordance with the invention, the dosage units are dosage units for the multi-symptomatic (MSR) treatment of colds / flu, which may contain one or more active substances for the treatment of colds / flu and can be used to treat one or more symptoms of colds / flu. Daily unit doses contain phenylephrine or pseudoephedrine, and nightly unit doses contain doxylamine succinate.

Common cold / flu symptoms can be selected from the group consisting of nasal / sinus secretion, runny nose, sneezing, headache, dry cough, sore throat, sinus pressure or sinus secretion

EP2 651 365 in the lungs, soreness / myalgia, wet cough / cough with expectoration, fever and combinations thereof.

Active substances for the treatment of cold / flu may contain additional anti-edema agents, expectorants, antihistamines, antitussives, painkillers and combinations thereof. In one example, the expectorant may be guaifenesin. In one example, the antihistamine may be chlorpheniramine. In one example, the antitussive agent may be selected from the group consisting of dextromethorphan, codeine and combinations thereof. In one example, painkillers may contain acetaminophen, ibuprofen, or combinations thereof. In one example, the dosage unit for controlling colds / flu, in particular the daytime formulation, may further contain caffeine, which is a stimulant.

Respiratory diseases can be characterized by a range of symptoms, such as runny nose, nasal and / or lung secretions, coughing, sneezing, pressure, headache, soreness, fever, fatigue and / or sore throat. The active substances usually used to treat these symptoms generally fall into the following categories: anti-edematous agents, anti-cholinergic agents, expectorants, antihistamines, antitussives, analgesics, antivirals, mucolytics, soothing agents, anesthetics and antibiotics. Such active substances may include over-the-counter pharmaceutical active substances and prescription pharmaceutical active substances.

Dosage units for the treatment of symptoms associated with respiratory disorders may be produced in a variety of product forms. Non-limiting examples of commonly used products include tablets, dragees, caplets, soft gelatin capsules, solid-filled capsules, liquid-filled capsules, enteral forms, prolonged-release forms, hard lozenges, liquid-filled lozenges, mouth and throat drops , gums, confectionery, "jellies", effervescent tablets, dry soluble powders (for example in sachets or oblong sachets), soluble film strips, sublingual tablets, buccal tablets, syrups, elixirs and liquids administered orally, candies, biscuits, patches for transdermal administration of the active substance, topical antibacterial compositions as well as

EP2 651 365 inhalants and topical creams and lotions that release volatiles that are inhaled through the nose into the respiratory tract, and combinations thereof. Oral compositions are usually swallowed immediately or dissolved slowly in the mouth.

Such unit doses can be prepared by any known or other effective method, as will be understood by those skilled in the art.

Non-limiting examples of over-the-counter pharmaceutical active substances and prescription pharmaceutical active substances beneficial for use in respiratory disorders include:

anti-edema agents, non-limiting examples of which include pseudoephedrine, phenylephrine, phenylpropanolamine, oxymetazoline, xylometazoline, naphazoline, 1-deoxyephedrine, ephedrine, propylhexedrine and combinations thereof;

anti-cholinergic agents, non-limiting examples of which include ipratropium, chlorpheniramine, brompheniramine, diphenhydramine, doxylamine, clemastine, triprolidine and combinations thereof;

expectorants, non-limiting examples of which include guaifenesin, ambroxol, bromhexine and combinations thereof;

antihistamines, non-limiting examples of which include chlorphenamine, desloratadine, levocetirizine, diphenhydramine, doxylamine, triprolidine, clemastine, feniramine, bromfeniramine, dexbromfeniramine, loratadine, cetirizine, cetramine omalizumab, dimethindene, oxatomide, pemirolast, pyrobutamine, pentigethide, tenaldine, picumast, tolpropamine, ramatroban, repirinast, aminoalkiloetery tosylate suplatastu, tazanolast, bromodiphenhydramine, tranilast, carbinoxamine, traksanoks, chlorfenoksyaminę, difenylpiralinę, embraminę, pmetyldifenhydraminę, moksastynę, orphenadrine, fenyltoloksaminę, setastynę, derivatives of ethylene diamine, chloropyraminę, chloroten, methapyrilene, pyrilamine, talastynę, tenyldiaminę hydrochloride tonzylaminy, tripelennamine, piperazine, chlorcyclizin, clocinizin, homochlorcyclizin, hydroxyzine, tricyclic antidepressants, phenothiazines, mecvazine, promethazine, thiazine methyl sulfate, azatadine, cyproheptadine, deptropine, desloratadine, isotipendyl,

EP2 651 365 olopatadine, rupatadine, antazoline, astemizole, azelastine, bepotastine, clemizole, ebastine, emedastine, epinastine, levocabastine, mebhydroline, mizolastine, fenindamine, terfenadine and their combinations;

antitussives (cough suppressants), non-limiting examples of which include dextromethorphan, menthol, codeine, chlorofedianol, levodropropizine and combinations thereof;

analgesics, non-limiting examples of which include acetaminophen, ibuprofen, ketoprofen, diclofenac, naproxen, aspirin and combinations thereof, as well as prescription analgesics, non-limiting examples of which include propoxyphene hydrochloride, codeine, meprididine and combinations thereof;

antiviral agents, non-limiting examples of which include amantidine, rimantidine, braonaryl, zanamivir, oseltamivir and combinations thereof;

mucolytics, non-limiting examples of which include ambroxol, N-acetylcysteine, and combinations thereof;

soothing agents, non-limiting examples of which include glycerin, honey, pectin, gelatin, red elm bark, liquid sugar, glycyrrhizinate (licorice) and combinations thereof;

anesthetics, non-limiting examples of which include phenol, menthol, phenol, diclonin hydrochloride, benzocaine, lidocaine, hexylresorcinol and combinations thereof;

antibiotics, non-limiting examples of which include nitroimidazole antibiotics, tetracyclines, penicillin-based antibiotics such as amoxicillin, cephalosporins, carbopenems, aminoglycosides, macrolide antibiotics, lincosamide antibiotics, 4-quinolones, fluoroquinolines, rifamides, and rifamides and any pharmaceutically acceptable salts, metabolites and combinations thereof with the above-mentioned active substances.

Dosage units may contain from about 0% to about 90%, optionally from about 0.0001% to about 75%, optionally from about 0.001% to about 50%, optionally from about 0.01% to about 25%, optionally from about 0.01% to about 15% and optionally from about 0.01% to 10% of an over-the-counter or prescription pharmaceutical active substance by weight of the composition forming the dosage unit.

EP2 651 365

Dosage units may contain from about 0.001 mg to about 1000 mg, optionally from about 2.5 mg to about 750 mg, and optionally from about 5 mg to about 650 mg of an over-the-counter or prescription pharmaceutical active ingredient per dosage unit.

Dosage units may also contain other active substances useful in the treatment of respiratory disorders, non-limiting examples of which include vitamins, minerals, elements, substances of plant origin, supplements, energy stimulants, probiotics, fiber, prebiotics and combinations thereof. Other active substances of this type are described below.

Dosage units may be administered in a single daily dose or in multiple daily doses.

Dosage units and systems may contain one or more active ingredients useful in the treatment of gastrointestinal disorders. Gastrointestinal disorders include a wide range of disorders, including viral infections, bacterial infections, autoimmune diseases, genetic diseases and the like. Gastrointestinal disorders may be characterized by any of a number of symptoms associated with gastrointestinal disorders such as diarrhea, constipation, indigestion, vomiting, upset stomach, cramps, gas, flatulence, abdominal pain and the like. The active substances usually used to treat these symptoms generally fall into the following categories: laxatives, anti-diarrheal agents, anti-emetics, anti-inflammatory agents, antacids, screening agents and flatulence agents. Such active substances can be over-the-counter pharmaceutical active substances and prescription pharmaceutical active substances.

Dosage units for the treatment of gastrointestinal symptoms associated with gastrointestinal disorders can be made into a variety of product forms, with non-limiting examples of commonly used products including tablets, dragees, caplets, soft gelatin capsules, solid filled capsules, liquid filled capsules, forms enteric, prolonged-release forms, hard lozenges, liquid filled lozenges, drops in the mouth and throat, gums, confectionery, "jellies", effervescent tablets, dry soluble powders, soluble film strips, sublingual tablets, buccal tablets, syrups,

EP2 651 365 elixirs and liquids administered orally, patches for transdermal administration of active substances, candies, biscuits, suppositories, as well as creams and lotions for topical use, which release substances that are absorbed in and through the skin and / or mucous membranes into the gastrointestinal tract, and their combinations.

Non-limiting examples of over-the-counter and prescription active pharmaceutical ingredients beneficial for use in gastrointestinal disorders include:

anti-diarrheal agents, non-limiting examples of which include loperamide, compositions containing bismuth, bismuth hydroxosalicylate, colloidal bismuth hydroxy citrate, bismuth hydroxy citrate, kaolin, pectin, clays such as attapulgite, activated carbon, and combinations thereof;

laxatives, non-limiting examples of which include fiber, resistant starch, resistant maltodextrin, pectin, cellulose, modified cellulose, polycarbophyll, senna, senosides, bisacodyl, sodium phosphate, docusate, magnesium citrate, mineral oil, glycerin, aloe vera, oil and their combinations;

anti-nausea and anti-emetic agents, non-limiting examples of which include compositions containing bismuth, phosphated carbohydrates, diphenhydramine, cyclysine, meclysine and combinations thereof;

antacids, non-limiting examples of which include sodium bicarbonate, sodium carbonate, calcium carbonate, magnesium carbonate, magnesium hydroxide, aluminum hydroxide, magnesium silicates, alginic acids, sodium alginate, magaldrate and combinations thereof;

anti-flatulence / anti-gas agents, non-limiting examples of which include simethicone, activated carbon, lactase, alpha-galactosidase enzymes, and combinations thereof;

H2 receptor antagonists, non-limiting examples of which include famotidine, ranitidine, cimetidine, nizatidine and combinations thereof;

proton pump inhibitors, non-limiting examples of which include omeprazole, lansoprazole, pantoprazole, rabeprazole and combinations thereof;

Anti-inflammatory agents, non-limiting examples of which include mesalamine; and any pharmaceutically acceptable salts, metabolites and combinations thereof;

screening agents, non-limiting examples of which include alginates; pectins and polysaccharides and combinations thereof with the above-mentioned active substances.

Dosage units may contain from about 0.001% to about 99%, optionally from about 0.01% to about 99%, optionally from about 0.1% to about 99%, optionally from about 1% to about 99%, and optionally from about 5% to about 95% of an over-the-counter or prescription pharmaceutical active substance by weight of the dosage unit composition.

Dosage units may contain from about 0.001 mg to about 5 g, optionally from about 0.01 mg to about 2 g, optionally from about 0.1 mg to about 1000 mg, and optionally from about 1 mg to about 1000 mg of the active pharmaceutical ingredient over the counter or prescription, per dosage unit.

Dosage units may also contain other active ingredients useful in the treatment of gastrointestinal disorders, non-limiting examples of which include vitamins, minerals, elements, plant derived substances, supplements, energy stimulants, probiotics, fiber, prebiotics and combinations thereof. Other active substances of this type are described below.

Dosage units may be administered in a single daily dose or in multiple daily doses.

Dosage units and systems may contain one or more other active substances which may be used in the treatment and / or prevention of respiratory disorders, may be used in the treatment and / or prevention of gastrointestinal disorders and may be used in the treatment and / or prevention of various other disorders and / or to provide general health and care benefits. General health and care benefits include a wide range of desirable benefits and benefits, including respiratory health, digestive health, immune system health, mobility and joint health, cardiovascular health, skin health, oral / dental health, hair health , eye health, system health

EP2 651 365 reproductive (including menstrual health), ear, nose and throat health and the like.

Users may desire many benefits, non-limiting examples of which include the lower incidence and severity of respiratory disorders and their symptoms; lower incidence and severity of gastrointestinal disorders and their symptoms; lower incidence and severity of symptoms associated with the menstrual cycle; lower incidence and severity of symptoms of ear, nose and throat disorders; lower incidence and severity of symptoms and effects: inflammation, immunodeficiency, tumors (especially cancers of the digestive and immune systems), appendicitis, autoimmune disorders, multiple sclerosis, Alzheimer's disease, amyloidosis, rheumatoid arthritis, arthritis, diabetes, insulin resistance, bacterial infections, viral infections, fungal infections , periodontitis, diseases of the genitourinary system, surgical injuries, metastatic disease caused by surgical intervention, sepsis, weight loss, weight gain, excessive fat accumulation, anorexia, fight against fever, cachexia, wound healing, ulceration, intestinal barrier infection, cardiovascular disease, coronary heart disease, anemia, coagulation disorders blood, kidney disease, central nervous system disorder, liver disease, ischemia, metabolic disorder, osteoporosis, endocrine disorders and epidermal diseases.

Non-limiting examples of health benefits include alleviating or reducing the effects of aging, including levels of awareness and mental activity, preventing weight loss during and after infection;

improving glycemic control, including increasing insulin sensitivity, reducing insulin resistance, and reducing postmeal glucose absorption; good, preserved and / or increased mobility and functioning of the joints; low cholesterol and low blood pressure; better appearance and skin tone, better hair appearance and well-being, and combinations thereof.

Non-limiting examples of other active substances of this type used to provide such benefits include vitamins, minerals, elements, substances of plant origin, energy stimulants, probiotics, fiber, prebiotics and combinations thereof.

EP2 651 365

Dosage units preferred for use with the other active substances in the present invention are prepared in a variety of product forms, with non-limiting examples of commonly used products including tablets, dragees, caplets, soft gelatin capsules, solid filled capsules, liquid filled capsules, enteric forms, prolonged release, hard lozenges, liquid filled lozenges, mouth and throat drops, gums, confectionery, "jellies", effervescent tablets, dry soluble powders, soluble film strips, syrups, elixirs and liquids administered orally, suppositories, patches for transdermal administration of active substances, candies, biscuits, suppositories, sublingual tablets, buccal tablets, slices for transdermal administration of active substances, beverages and food products, including candies and biscuits; as well as topical antibacterial compositions, topical creams and lotions that release substances that are absorbed in and through the skin and / or mucous membranes, inhalants, and topical creams and lotions that release volatiles that are inhaled by nose for breathing.

The dosage units and systems of the present invention may contain one or more vitamins, non-limiting examples of which include provitamin and all forms of vitamins C, D, A, B, E and combinations thereof.

When certain vitamins (including certain minerals, metals, elements and the like) were introduced as ingredients in the form of capsules, tablets and powder, the real amounts of many of these ingredients, in grams per unit dose, are often extremely small and make it difficult to use , measure and process individual ingredients. Therefore, such components are usually prepared or purchased as a premix in or on a carrier such as sucrose or lactose. In relation to the weight percentage of a given vitamin constituting a certain percentage of the premix or vitamin carrier blend, such percentages can vary considerably depending on the vitamin and the desired amount of vitamin, as will be understood by one of ordinary skill in the art. In general, however, in the case of vitamins in or on a carrier, the vitamin may be, in percent by weight of the vitamin relative to the carrier, from about 0.0001% to about 50%, optionally from about 0.001% to about 45%, optionally from about 0.001% up to about 40%, by weight of the vitamin-carrier composition.

EP2 651 365

The dosage units and systems of the present invention may contain vitamin C. It is believed that more than 20% of cold patients have a suboptimal level of vitamin C. The preferred form of vitamin C for use in the present invention is ascorbic acid or an equivalent salt of ascorbic acid (e.g., calcium ascorbate ) or an equivalent derivative of ascorbic acid. Vitamin C may be in an immediate release or extended release form.

Vitamin C may be administered in a single daily dose or in multiple daily doses.

Dosage units may contain from about 1 mg to about 5000 mg, optionally from about 20 mg to about 2000 mg, optionally from about 60 mg to about 1500 mg, and optionally from about 100 mg to about 1000 mg of vitamin C, per dosage unit.

The systems can provide from about 1 mg to about 5000 mg, optionally from about 20 mg to about 2000 mg, optionally from about 60 mg to about 1500 mg, and optionally from about 100 mg to about 1000 mg of vitamin C, per day.

Dosage units and systems may contain vitamin D. Non-limiting examples of vitamin D preferred for use in the present invention include vitamin D3 (cholecalciferol), vitamin D2 (ergocalciferol) and combinations thereof. Additional non-limiting examples include vitamin D metabolites, including calcidiol, calcitriol, and combinations thereof. Vitamin D can be obtained from natural or synthetic sources, including an extract from Solanum glaucophyllum (malacoxylone), Trisetum flavescens (meadow clover) or Cestrum diurnum. Both pure vitamin D and / or vitamin D glycosides can be used.

Vitamin D may be used to treat and / or prevent breathing disorders and / or provide to provide general health and care benefits.

Vitamin D may be administered in a single daily dose or in multiple daily doses.

Dosage units may deliver, in a single daily dose or in multiple daily doses, from about 50 IU to about 500,000 IU, optionally from about 500 IU to about 500,000 IU, optionally from about 1000 IU to about 500,000 IU, optionally from about 2,000 IU to about 100,000 IU, optionally from about 10,000 IU to about 50,000 IU, and optionally from about 20,000 IU to about 40,000 IU of cholecalciferol per day.

EP2 651 365

To treat the symptoms of a respiratory disorder that has already occurred, it may be administered to a representative of a mammalian group, for example a human, in a single daily dose or multiple daily doses, from about 50 IU.

up to about 500,000 IU, optionally from about 500 IU to about 500,000 IU, optionally from about 1,000 IU to about 500,000 IU, optionally from about 5,000 IU to about 500,000 IU, optionally from about 10,000 IU to about 100,000 IU and optionally from about 20,000 IU to about 50,000 IU cholecalciferol per day.

For the treatment or prevention of symptoms of respiratory disturbance, a mammalian cluster may be administered in a single daily dose or in multiple daily doses of from about 50 IU to about 10,000 IU, optionally from about 500 IU to about 10,000 IU, optionally from about 1,000 IU to about 5000 IU, optionally from about 2000 IU to about 5000 IU, and optionally from about 2000 IU to about 4000 IU cholecalciferol per day.

Units and dosing systems can also provide vitamin

D2 (ergocalciferol). Dosage units may deliver, in a single daily dose or in multiple daily doses, from about 50 IU to about 500,000 IU, optionally from about 500 IU to about 500,000 IU, optionally from about 1000 IU to about 500,000 IU and optionally from about 5000 IU

up to about 500,000 IU of vitamin D2 per day.

Dosage units may contain from about 1.25 pg to about

12.5 mg, optionally from about 12.5 pg to about 12.5 mg, optionally from about 25 pg to about 12.5 mg, and optionally from about 125 pg to about 12.5 mg of vitamin D3 and / or D2, on dosage unit.

Dosage units and systems may also contain vitamin A and / or pro-vitamin forms of vitamin A, such as carotenes. Vitamin A and carotene can be obtained from animal or plant sources. The animal form of carotene is divided into retinol and dehydroretinol, while plant carotene can be divided into four very strong groups - alpha-carotene, beta-carotene, gamma-carotene and crypto-carotene. Vitamin A can provide many general health and care benefits.

Non-limiting examples of vitamin A useful in the present invention include vitamin A, retinol, retinyl palmitate, retinyl acetate,

EP2 651 365 retinyl propionate, beta-carotene, alpha-carotene, beta-cryptoxanthine and mixtures thereof.

Vitamin A may be administered in a single daily dose or in multiple daily doses.

Dosage units and systems may provide, in a single daily dose or multiple daily doses, from about 100 IU to about 10,000 IU, optionally from about 300 IU to about 5,000 IU, optionally from about 400 IU to about 2,000 IU and optionally from about 500 IU IU to about 1000 IU vitamin A per day. The amount of vitamin A types can be expressed in terms of IU or RAE (equivalent to retinol activity), which corresponds to the equivalent amount of retinol in micrograms. For example, 10,000 IU vitamin A corresponds to 3,000 RAE or 3,000 pg retinol.

Dosage units may contain from 30 pg to about 4545 pg, optionally from about 90 pg to about 1500 pg, optionally from about 120 pg to about 600 pg, and optionally from about 150 pg to about 300 pg of vitamin A (in the form of retinol), on unit dose.

Dosage units and systems may contain one or more B vitamins. Compositions containing eight specific B vitamins are generally referred to as "vitamin B complex". Individual compositions of vitamin B are determined by the specific name of each vitamin (e.g. B1, B2, B3 etc.). Vitamins B often work together to provide many health benefits, non-limiting examples of which include maintaining and accelerating metabolism, maintaining healthy skin and muscle tone, better functioning of the immune and nervous system, promoting cell growth and division, and together they can also help combat stress symptoms , depression and cardiovascular disease. All B vitamins are soluble in water and are distributed throughout the body. Most B vitamins should be replenished daily because any excess is excreted in the urine.

Non-limiting examples of vitamin B include vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine, pyridoxal or pyridoxamine), vitamin B7 (biotin), vitamin B9 (acid) folic acid), vitamin B12 (cyanocobalamin) and combinations thereof.

EP2 651 365

Vitamins B described below may be administered in a single daily dose or in multiple daily doses.

Dosage units may contain from about 200 pg to about 50 mg, optionally from about 400 pg to about 20 mg, and optionally from about 500 pg to about 10 mg of vitamin B1, per dosage unit. The systems can deliver from about 200 pg to about 50 mg, optionally from about 400 pg to about 20 mg, and optionally from about 500 pg to about 10 mg of vitamin B1 per day.

Dosage units may contain from about 100 pg to about 200 mg, optionally from about 200 pg to about 100 mg, and optionally from about 500 pg to about 50 mg of vitamin B2, per dosage unit. The systems can deliver from about 100 pg to about 200 mg, optionally from about 200 pg to about 100 mg, and optionally from about 500 pg to about 50 mg of vitamin B2 per day.

Dosage units may contain from about 1 mg to about 500 mg, optionally from about 2 mg to about 250 mg, and optionally from about 5 mg to about 100 mg vitamin B3, per dosage unit. The systems can deliver from about 1 mg to about 500 mg, optionally from about 2 mg to about 250 mg, and optionally from about 5 mg to about 100 mg of vitamin B3 per day.

Dosage units may contain from about 500 pg to about 1000 mg, optionally from about 1000 pg to about 500 mg, and optionally from about 2000 pg to about 100 mg of vitamin B5, per dosage unit. The systems can deliver from about 500 pg to about 1000 mg, optionally from about 1000 pg to about 500 mg, and optionally from about 2000 pg to about 100 mg of vitamin B5 per day.

Dosage units may contain from about 200 pg to about 500 mg, optionally from about 500 pg to about 250 mg, and optionally from about 1000 pg to about 100 mg of vitamin B6, per dosage unit. The systems can deliver from about 200 pg to about 500 mg, optionally from about 500 pg to about 250 mg, and optionally from about 1000 pg to about 100 mg of vitamin B6 per day.

Dosage units may contain from about 200 pg to about 500 mg, optionally from about 500 pg to about 250 mg, and optionally from about 1000 pg to about 100 mg of vitamin B6, per dosage unit. The systems can deliver from about 200 pg to about 500 mg, optionally from about 500 pg to about 250 mg, and optionally from about 1000 pg to about 100 mg of vitamin B6 per day.

EP2 651 365

Dosage units may contain from about 50 pg to about 2000 pg, optionally from about 100 pg to about 1000 pg, and optionally from about 200 pg to about 500 pg of vitamin B9, per dosage unit. The systems can deliver from about 50 pg to about 2000 pg, optionally from about 100 pg to about 1000 pg, and optionally from about 200 pg to about 500 pg of vitamin B9, per day.

Dosage units may contain from about 0.5 pg to about 3000 pg, optionally from about 1 pg to about 1500 pg, and optionally from about 2 pg to about 750 pg of vitamin B12, per dosage unit. The systems can deliver from about 50 pg to about 2000 pg, optionally from about 100 pg to about

1000 pg and possibly from about 200 pg to about 500 pg of vitamin B9 per day.

Units and dosing systems may contain vitamin E. Vitamin E is a fat-soluble antioxidant and provides protection against oxidative damage to cells. The term "vitamin E" usually includes eight different chemical forms: four tocopherols and four tocotrienols. The most biologically active form of vitamin E is alpha-tocopherol.

Vitamin E may be administered in a single daily dose or in multiple daily doses.

Dosage units may contain from about 1 mg to about 1000 mg of vitamin E, optionally from about 1 mg to about 800 mg of vitamin E, and optionally from about 2 mg to about 200 mg of vitamin E, per dosage unit.

Systems can provide from about 1 mg to about 1000 mg of vitamin E, optionally from about 1 mg to about 800 mg of vitamin E, and optionally from about 2 mg to about 200 mg of vitamin E, per day.

Dosage units and systems may contain minerals, metals and / or elements. Non-limiting examples of minerals, metals and elements useful in the systems of the present invention include: zinc, iron, calcium, iodine, copper and selenium. The right dose of iron, zinc, copper and selenium supports the Th1 cytokine-dependent immune response, which bypasses the Th2 anti-inflammatory response and eliminates the increased risk of extracellular infection. Minerals, metals and / or elements, if present, may be on or in a preferred carrier and constitute from about 1% to about 50% by weight and optionally from about 2% to about 30% by weight of a composition containing minerals, metals or elements and carrier.

EP2 651 365

Minerals, metals and elements described herein may be administered in a single daily dose or in multiple daily doses.

The dosage units and systems of the present invention may contain zinc. Zinc is an important trace element in many biological and biochemical pathways. Zinc salts are effective against direct pathogens, and it has also been found that both zinc gluconate and zinc glyconate gluconate reduce the duration of common cold symptoms.

Dosage units may contain zinc in an amount of from about 1 mg to about 50 mg, optionally from about 1 mg to about 30 mg, and optionally from about 1 mg to about 25 mg, per dosage unit.

The systems can supply zinc in an amount of from about 1 mg to about 50 mg, optionally from about 1 mg to about 30 mg, and optionally from about 1 mg to about 25 mg, per day.

Dosage units and systems may contain iron. Iron (in the form of ferrous ions Fe²⁺) is an essential trace element used by almost all living organisms. It is used in hemoglobin, which carries oxygen to the cells. Too little iron can cause anemia, causing fatigue and fatigue, and is associated with reduced cellular immunity. However, too much iron can be fatal.

A non-limiting example of iron preferred for use in the present invention is iron in the form of a bisglycinate salt, available under the trade name "Ferrochel" from Albion Laboratories, Inc., located in Clearfield, Utah in the United States.

Dosage units may contain from about 2 mg to about 18 mg, optionally from about 3 mg to about 15 mg, and optionally from about 3 mg to about 10 mg of iron, per dosage unit.

The systems can deliver from about 2 mg to about 18 mg, optionally from about 3 mg to about 15 mg, and optionally from about 3 mg to about 10 mg of iron, per day.

Dosage units and systems may contain calcium. Calcium is essential for all living organisms and is the main material used in bone and shell mineralization. Calcium is necessary for the proper development and preservation of bones and teeth.

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Dosage units may contain from about 200 to about 1500 mg, optionally from about 250 mg to about 1200 mg, and optionally from about

500 mg to about 1000 mg calcium, per dosage unit.

The systems can deliver from about 200 to about 1500 mg, optionally from about 250 mg to about 1200 mg, and optionally from about 500 mg to about 1000 mg calcium, per day.

Units and dosage systems may contain iodine. Iodine is required in trace amounts in most living organisms and is widely used in medicine. Although it is generally only present and required in trace amounts, iodine plays a key role in general care, especially for children.

Dosage units may contain from about 20 pg to about 1 mg of iodine, optionally from about 30 pg to about 500 pg, and optionally from about 30 pg to about 100 pg iodine, per dosage unit.

The systems can deliver from about 20 pg to about 1 mg of iodine, optionally from about 30 pg to about 500 pg, and optionally from about 30 pg to about 100 pg iodine, per day.

Dosage units and systems may contain copper. Copper is a trace element that is used for biological electron transport, wound healing, red blood cell production, and increased immunity and performance. Copper is used as an antibacterial and anti-arthritic agent.

Dosage units may contain from about 200 pg to 10 mg, optionally from about 500 pg to about 9 mg, and optionally from about 1 mg to about 9 mg copper, per dosage unit.

The systems can deliver from about 200 pg to 10 mg, optionally from about 500 pg to about 9 mg, and optionally from about 1 mg to about 9 mg of copper per day.

Units and dosage systems may contain selenium. Although it is toxic in high doses, selenium is an essential micronutrient for animals. In humans, selenium is a trace element that acts as a cofactor to reduce the amount of antioxidant enzymes. Selenium may act as an antioxidant and / or increase immunological activity.

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Dosage units may contain from about 15 pg to about 400 mg, optionally from about 20 pg to about 300 mg, and optionally from about 50 pg to about 200 mg of selenium, per dosage unit.

Dosage units deliver from about 15 pg to about 400 mg, optionally from about 20 pg to about 300 mg, and optionally from about 50 pg to about 200 mg of selenium per day.

Dosage units and systems may contain substances of plant origin. As used herein, non-limiting examples of plant-derived substances include those used in traditional native American, Chinese, Ayurvedic and Japanese native medicine, including flowers, leaves, stems and roots of plants, as well as extracts and separate active ingredients from flower, leaves, stems and roots plants.

Some particularly useful substances of plant origin are described below. Particularly useful substances of plant origin are those that bring beneficial effects on the respiratory system, digestive system, general health and energy effects.

Plant-derived substances may be administered in a single daily dose or in multiple daily doses.

Dosage units and systems may also contain plant-derived substances that may be particularly useful in the prevention and / or treatment of respiratory disorders and / or maintaining respiratory health. Non-limiting examples of other herbal substances of this type include: Andrographis (Andrographis paniculata), garlic (Allium sativum L.), Eleutherococcus senticosus (Siberian ginseng), guaiacol component (from essential cinnamon oils (Cinnamomum aromaticum), clove (Syzygium aromaticum, Eugenia aromaticum, Eugenia caryophyllata) Cinnamomum zeylanicum, Cinnamomum verum, Cinnamomum loureiroi, Cinnamomum camphora, Cinnamomum tamala, Cinnamomum burmannii), borage seed oil (Borago officinalis), sage (Salvia officinalis, Salvia lavandulaefolia, Salvia lavandulifolia), membranaceae (Astragalus membraneceus), overgrown sage (Eupatorium perfoliatum), chamomile (Matricaria recutita, Chamaemelum nobile), cordyceps (Cordyceps sinensis), echinacea (Echinacea angustifacea DC, Echincha black (Sambucas nigra L.), spurge, ginseng (American ginseng, Asian ginseng, Chinese ginseng, Korean ginseng

EP2 651 365 red, Panax ginseng: Panax ssp., Including ginseng and P.

quinquefolius L.), Canadian booze (Hydrastis canadensis L.), celandine celandine (Chelidonium majus), horseradish (Armoracia rusticana, Cochlearia armoracia), kiwi (Actinidia deliciosa, Actinidia chinensis), lamella (Grifola) Visvum album L.), geranium (Pelargonium sidoides), peppermint / menthol oil (Mentha x peperita L.), bee putty, red elm (Ulmus rubra Muhl, Ulmus fulva Michx), oxalis (Rumex acetosa L., Rumex acetosella L.), thyme / thyme extract (Thymus vulgaris L.), blue baptism (Baptisia australis), quercetin (flavanol) and / or combinations thereof.

Non-limiting examples of substances of plant origin include Andrographis paniculata, Allium sativum, Eleutherococcus senticosus (Siberian ginseng) and the guaiacol component, which are described below.

Dosage units and systems may contain andrographis extract, its active ingredient or mixtures thereof. Andrographis as used herein means a plant of the genus Andrographis, with a limited number of species within this genus occurring predominantly in Asia. Only a few species have a healing effect. In one embodiment, the plant is of the species Andrographis paniculata, which may be referred to as Kalmegh in Ayurvedic medicine. Andrographis is usually standardized by measuring the total amount of andrographolides, which often make up 5 to 20% of the extract.

Andrographis has been shown to be effective in the treatment of colds and flu and can help reduce the severity of symptoms or reduce the duration of a cold. Andrographolides are the main components of andrographis.

Dosage units may contain Andrographis paniculata in amounts from about 5 mg to about 50 mg, optionally from about 10 mg to about 40 mg, and optionally from about 15 mg to about 30 mg of andrografolides, per dosage unit.

Systems can deliver Andrographis paniculata in amounts from about 5 mg to about 50 mg, optionally from about 10 mg to about 40 mg, and optionally from about 15 mg to about 30 mg andrografolides, per day.

Units and dosage systems may contain Allium sativum (garlic). Allium sativum has been shown to be effective in reducing the number of many cytokines and chemokines involved in the immune response to viral infections. Combination of Allium sativum and / or allicin, component of Allium

EP2 651 365 sativum, in the compositions of the present invention can provide relief of cold and flu symptoms.

Dosage units may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about

15%, optionally from about 1% to about 10%, and optionally from about 3% to about 10% Allium sativum, by weight of the dosage unit composition.

Dosage units may contain from about 100 mg to about 10,000 mg, optionally from about 200 mg to about 5000 mg, optionally from about 500 mg to about 2,000 mg Allium sativum, per dosage unit.

The systems can deliver from about 100 mg to about 10,000 mg, optionally from about 200 mg to about 5000 mg, optionally from about 500 mg to about 2000 mg Allium sativum, per day.

Dosage units may contain from about 1000 pg to about 100,000 pg, optionally from about 2000 pg to about 50,000 pg, and optionally from about 5000 pg to about 20,000 pg of allicin, per dosage unit.

The systems can deliver from about 1000 pg to about 100,000 pg, optionally from about 2000 pg to about 50,000 pg, and optionally from about 5000 pg to about 20,000 pg of allicin, per day.

Units and dosage systems may contain an extract of Eleutherococcus senticosus. Eleutherococcus is an adaptogen, it is an anti-cholesterol agent, it is a moderate anti-inflammatory agent, it is an antioxidant, it can strengthen immunity and is a sedative and immunity enhancer.

Dosage units may contain from about 0.001 mg to about

1 500 mg, optionally from about 0.01 mg to about 1000 mg, optionally from about

0.1 mg to about 500 mg, optionally from about 1 mg to about 250 mg, and optionally from about 1 mg to about 100 mg of Eleutherococcus senticosus extract, per dosage unit.

The systems can provide from about 0.001 mg to about 1500 mg, optionally from about 0.01 mg to about 1000 mg, optionally from about 0.1 mg to about 500 mg, optionally from about 1 mg to about 250 mg, and optionally from about 1 mg to about 100 mg of Eleutherococcus senticosus extract per day.

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Units and dosage systems may contain the guaiacol component.

The guaiacol component may be a mixture of ingredients containing guaiacol or its

4-substituted derivative. Non-limiting examples of such 4-substituted guaiacol derivatives include eugenol, iso-eugenol, dihydroeugenol, vanyl butyl ether, vanillin (4-formyl guaiacol), 5-propenyl guuaetol, 4-ethyl-2-methoxyphenol, 4-allyl-2-methoxyphenol acetate metylogwajakol. In one embodiment, the 4-substituted guaiacol derivative is eugenol.

Each of the cinnamon, clove and cinnamon contain guaiacol or its 4-substituted derivatives or mixtures thereof. Therefore, essential oils, extracts or any product obtained from cinnamon fragrant clove, cinnamon or any mixture thereof can be used as the source of the guaiacol component in the present invention. Essential oils of cinnamon, clove or cinnamon may be particularly useful. Clove oil may be particularly useful. Products obtained from fragrant cinnamon, clove or cinnamon may contain eugenol in useful quantities.

The guaiacol component may constitute from about 0.0001% to about 1%, optionally from about 0.001% to about 0.5%, optionally from about 0.001% to about 0.07% and optionally from about 0.001% to about 0.02% by weight of the dosage unit composition.

Other substances of plant origin may exert beneficial effects on the gastrointestinal tract, non-limiting examples of which include soothing or mitigating effects, gas-reducing or carminative effects, anti-diarrheal or astringent effects, laxative or laxative, catheteric, cleansing or diuretic, analgesic, antispasmodic or diastolic effects. stimulant or sedative effects or digestive processes.

Non-limiting examples of other plant-type substances of this type useful in these methods and systems include substances of the ginger family (Zigiberaceae), licorice root (Glycyrrhizin glabra), marshmallow root (Althea officinalis, Althea radix), chamomile (Matricariae flos, Chamaemelum nobile), fennel oil, fennel seeds (Foeniculum vulgare), cumin oil, caraway seeds (Carum carvi, Carvi fructus, Carvi aetheroleum), lemon balm (Melissae folium, Melissa), shanty herb (Marrubii herba), alpha-linoleic acid, linseed (Lini semen), and combinations thereof.

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Ginger (Zigiberaceae) substances are useful, such as the non-limiting example of Zingiber officinale.

Ginger can be used in a form selected from the group consisting of rhizome (root), equivalent extract, tincture, oil, infusion, decoction, crystals, powder and combinations thereof.

Dosage units may contain from about 50 mg to about 10 g, optionally from about 50 mg to about 5 g, and optionally from about 100 mg to about 5 g ginger (Zingiber officinale), per dosage unit.

The systems can deliver from about 50 mg to about 10 g, optionally from about 50 mg to about 5 g, and optionally from about 100 mg to about 5 g of ginger (Zingiber officinale) per day.

Dosage units and systems may contain substances that have the advantage of stimulating / increasing energy. Such energy benefits are useful for overall health and well-being, as well as being useful in the treatment of disorders such as respiratory and gastrointestinal disorders, to provide those affected with more energy or to feel more energy to enable such people to continue exercising their daily activities during treatment of a disorder such as a respiratory or gastrointestinal disorder.

Non-limiting examples of such substances include the following, many of which have many benefits, including benefits for respiratory and gastrointestinal disorders: caffeine (stimulant and diuretic) vitamin B complex, green and black tea (which can be used due to the stimulant and diuretic properties of the caffeine contained in them), taurine, rhodiola rosea, Siberian ginseng (Eleutherococcus senticosus), vitamin C, iron, CoQ10, L-carnitine, L-theanine, guarana (Paullinia cupana), magnesium, Schizandra chinensis, herba mate (Ilex paraguariensis), goji berries (scarlet wolfberry), quercetin (flavonol), amalaki (Indian gooseberry), acai (of the genus Euterpe), maca (Lepidium meyenii), ginkgo, glucuronolactone, ginseng (from the species Panax family, from the genus 11 species of slow-growing perennial plants with fleshy roots, from the family Araliaceae), Echinacea (from the genus nine species herbal plants of the family Asteraceae), rooibos (Aspalathus linearis), dehydroepiandrosterone DHEA, aromas and aromatherapy substances, Indian mulberry (Morinda citrifolia), mangosteen (Garcinia mangostana) and selenium.

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The energy stimulant may be administered in a single daily dose or in multiple daily doses.

Dosage units may contain from about 1 pg to about 10 g, optionally from about 1 mg to about 5 g, and optionally from about 100 mg to about

5 g of energy-boosting / energy-enhancing substance per dosage unit.

The systems can deliver from about 1 pg to about 10 g, optionally from about 1 mg to about 5 g, and optionally from about 100 mg to about 5 g of energy stimulant / boosting substance per day.

Dosage units and systems may contain a probiotic. Probiotics may be useful in the treatment and / or prevention of respiratory disorders, treatment and / or prevention of gastrointestinal disorders, as well as to provide general health benefits. The term "probiotic" as used herein includes natural and / or genetically modified microorganisms, viable or dead; processed compositions of microorganisms;

their components and elements such as proteins and carbohydrates or purified bacterial enzyme fractions; which have a positive effect on the host organism. Commonly used probiotics in the present invention are in the form of viable cells. However, the application can be extended to non-viable cells, such as dead cultures or compositions containing beneficial probiotic related factors. Dead cultures may contain thermally killed microorganisms or microorganisms killed as a result of exposure to variable pH or pressure. For the purposes of the present invention, it is contemplated that the term "probiotic" will further include metabolites produced by the fermentation microorganisms, unless they are listed separately. These metabolites may be released into the fermentation medium or may be stored in the microorganism. The term "probiotic" as used herein also includes bacteria, bacterial homogenates, bacterial proteins, bacterial extracts, bacterial enzyme supernatants, and mixtures thereof that, when administered at a therapeutic effective dose, perform beneficial functions for the animal host.

As used herein, the term "therapeutically effective dose" when used in reference to a probiotic described herein means that amount of probiotic is sufficient to provide the desired effect or benefit to the animal host requiring treatment,

EP2 651 365 but low enough to avoid undesirable effects such as toxicity, irritation or allergic reaction commensurate with a reasonable benefit-risk balance when using the method of the present invention. The specific "therapeutically effective dose" will vary with such factors as the particular disorder being treated, the animal host's physical condition, duration of treatment, nature of the adjunct therapy (if used), specific dosage form used, carrier used, solubility of the dosage form, and specific dosing regimen.

The abbreviation "CFU" refers to "colony forming unit" and as used herein means the number of probiotic cells disclosed in the number of microorganisms on agar plates, as will be commonly understood in the art.

Non-limiting examples of probiotic bacteria preferred for use in the present invention include Streptococcus lactis, Streptococcus cremoris, Streptococcus diacetylactis, Streptococcus thermophilus, Lactobacillus bulgaricus, Lactobacillus acidophilus, Lactobacillususvactus, Lactobacillus, Lactobacilli, Lactobacilli, Lactobacillus , Lactobacillus thermophilus, Lactobacillus fermentii, Lactobacillus salivarius, Lactobacillus reuteri, Lactobacillus brevis, Lactobacillus paracasei, Lactobacillus gasseri, Pediococcus cerevisiae, Bifidobacterium longum, Bifidobacterium infantis, Bifidobacterium adolescentis, Bifidobacterium bifidum, Bifidobacterium animalis, Bifidobacterium pseudolongum, Bifidobacterium thermophilum, Bifidobacterium lactis, Bifidobacterium bulgaricus, Bifidobacterium breve, Bifidobacterium subtilis , Escherichia coli and strains of the genera including Bacillus, Bacteroides, Enterococcus (e.g. Enterococcus faecium) and Leuconostoc, and mixtures and / or combinations thereof.

Embodiments of dosage units according to the present invention include lactic acid bacterial strains selected from the genera Lactobacillus and Bifidobacterium, such as Lactobacilius acidophilus and Bifidobacterium lactis, and combinations and / or mixtures thereof.

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In one embodiment, the dosage unit comprises a composition comprising a therapeutically effective dose of genus bacteria

Lactobacillus.

Non-limiting examples of bacteria of the genus Lactobacillus preferred for use in the present invention include the strains Lactobacillus bulgaricus, Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus bifidus, Lactobacillus casei, Lactobacillus lactis, Lactobacillus plantarum, Lactobacilli, Lactobacilli , Lactobacillus reuteri, Lactobacillus brevis, Lactobacillus paracasei, Lactobacillus gasseri and their combinations.

The probiotic may be administered in a single daily dose or in multiple daily doses.

Dosage units may contain at least about 10³ CFU, possibly from about 10³ up to about 10¹⁴ CFU, possibly from about 10⁶ to about

10¹² CFU and possibly from about 10⁸ up to about 10¹¹ CFU Lactobacillus, per dosage unit. The bacteria of the Lactobacillus family can be administered in any viable form or in the form of dead cells, or distillates, isolates or other fractions of the fermentation products of the bacteria of the Lactobacillus family used in the present invention, or any mixture or combination thereof.

Systems can provide at least about 10³ CFU, possibly from about 10³ up to about 10¹⁴ CFU, possibly from about 10⁶ up to about 10¹² CFU and possibly from about 10⁸ up to about 10¹¹ CFU Lactobacillus, during the day.

In one embodiment, the dosage units comprise a composition comprising a therapeutically effective dose of a Bifidobacterium strain, which may be from a mammal. The treated mammalian cluster representative and mammalian source of isolation of the Bifidobacterium strain may or may not be independent.

Non-limiting examples of bacteria of the genus Bifidobacterium that are preferred for use in the present invention include the strains of Bifidobacterium longum, Bifidobacterium infantis, Bifidobacterium adolescentis, Bifidobacterium bifidum, Bifidobacterium animalis, Bifidobacterium pseudolongif, Bifidobacterium Bacteridium, Bifidobacterium thermophilum, and / or combinations.

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In one embodiment, dosage units may contain at least about 10 in the present specification³ CFU, possibly from about 10³ up to about 10¹⁴ CFU, possibly from about 10⁶ up to about 10¹² CFU and possibly from about 10⁸ up to about 10¹¹ CFU Bifidobacterium, per dosage unit.

Bifidobacterium family bacteria can be administered in any viable form or in the form of dead cells, or distillates, isolates or other fractions of the fermentation products of the Bifidobacterium family of bacteria used in the present invention, or any mixture or combination thereof.

Systems can provide at least about 10³ CFU, possibly from about 10³ up to about 10¹⁴ CFU, possibly from about 10⁶ up to about 10¹² CFU and possibly from about 10⁸ up to about 10¹¹ CFU Bifidobacterium, during the day.

As part of the dosage unit composition, the probiotic, in the form of a lyophilized powder (as will be understood by a person skilled in the art), may constitute from about 1% to about 50%, optionally from about 1% to about 40%, optionally from about 1 % to about 30% and optionally from about 2% to about 20% by weight of the dosage unit composition.

Dosage units and systems may also contain fiber. Fiber can be useful in the treatment and / or prevention of gastrointestinal disorders as well as to provide general health benefits associated with the gastrointestinal tract. The term "fiber" as used herein means carbohydrate polymers, including those naturally occurring in the food consumed; those obtained from the raw material by physical, enzymatic or chemical means; and synthetic carbohydrate polymers that are resistant to digestion and absorption in the small intestine and undergo partial fermentation in the large intestine.

Non-limiting examples of fibers and analogous carbohydrate polymers include pectin, psyllium fiber, guar gum, xanthan gum, alginates, acacia, fructooligosaccharides, inulin, agar, beta glucans, chitins, dextrins, lignins, cellulose, polysaccharide, starch and mixtures and / or combinations thereof.

In one embodiment, the fiber is glucose polymers, preferably those that have branched chains. Among these preferred fibers there is one commercially available under the trade name "Fibersol2" in the offer of Matsutani Chemical Industry Co. based in Itami City in Hyogo, Japan.

EP2 651 365

Other non-limiting examples of preferred fibers include oligosaccharides such as inulin and its hydrolysis products commonly known as fructooligosaccharides, galacto-oligosaccharides, xylo-oligosaccharides and oligoscent starch.

Fiber can be provided in any preferred form.

A non-limiting example is in the form of a plant substance that contains fiber. Non-limiting examples of preferred plant substances include asparagus, artichoke, onion, wheat, chicory, beet pulp, residues of such plant substances, and mixtures and / or combinations thereof.

A non-limiting example of fiber from such a plant substance is inulin extract from chicory extract. Preferred inulin extracts can be purchased from Orafti SA from Belgium under the trade name Raftiline®. Optionally, the fiber may be in the form of fructooligosaccharide, which can be purchased from Orafti SA from Belgium under the trade name Raftilose®. Optionally, the oligosaccharide can be obtained by hydrolysis of inulin, by enzymatic methods or by using microorganisms, as will be understood by those skilled in the art. Alternatively, the fiber may be inulin and / or sugared inulin available from Cargill Health & Food Technologies based in Wayzata, Minnesota MN in the USA, or from Cosucra SA based in Warcoing in Belgium.

In another embodiment, the fiber may be psyllium fiber, which may be purchased from the Procter & Gamble Company based in Cincinnati, Ohio, under the trade name Metamucil®.

Fiber can be given as a single daily dose or multiple daily doses.

Dosage units may contain from about 10 mg to about 100 g, optionally from about 50 mg to about 50 g, optionally from about 100 mg to about 50 g, optionally from about 500 mg to about 50 g and optionally from about 1 g to about 40 g fiber, per dosage unit.

The systems can deliver from about 10 mg to about 100 g, optionally from about 50 mg to about 50 g, optionally from about 100 mg to about 50 g, optionally from about 500 mg to about 50 g and optionally from about 1 g to about 40 g of fiber per day.

EP2 651 365

Units and dosage systems may contain a prebiotic. Prebiotics can be useful in the treatment and / or prevention of gastrointestinal disorders as well as to provide general health benefits associated with the gastrointestinal tract.

The term "prebiotic" as used herein includes substances or compounds that favorably affect a mammalian host by selectively stimulating the growth and / or activity of one or more probiotic bacteria in the digestive tract of an animal host, thereby maintaining normal health or improving health host. Usually, prebiotics are carbohydrates (such as oligosaccharides), but the term "prebiotic" as used herein does not exclude substances other than carbohydrates. Many forms of "fiber" exhibit some degree of prebiotic activity. Therefore, there is a significant duplication of the effects of substances that can be classified as "prebiotics" and those that can be classified as "fibers".

Non-limiting examples of prebiotics preferred for use in the compositions and methods include fiber from plantain psyllium, fructooligosaccharides, inulin, oligofructose, galacto-oligosaccharides, isomalto-oligosaccharides xylo-oligosaccharides, sojooligosacharydy, glucooligosaccharides, mannanooligosacharydy, arabinogalactan, arabinoxylan, lactosucrose, glucomannan, lactulose, polydextrose, oligodekstran, gencjooligosacharyd, pectin oligosaccharide, xanthan gum, gum arabic, hemicellulose, resistant starch and its derivatives, reduced starch and mixtures and / or combinations thereof.

The prebiotic may be administered in a single daily dose or in multiple daily doses.

Dosage units may contain from about 100 mg to about 100 g, optionally from about 500 mg to about 50 g, and optionally from about 1 g to about 40 g of prebiotic, per dosage unit.

The systems can deliver from about 100 mg to about 100 g, optionally from about 500 mg to about 50 g, and optionally from about 1 g to about 40 g of prebiotic per day.

Dosage units and systems may contain at least one polyphenol. Polyphenols are known to have antioxidant and anti-inflammatory effects, and therefore may be useful in the treatment and / or prevention of disorders

EP2 651 365 respiration and gastrointestinal, as well as to provide general health benefits. Non-limiting examples of polyphenol sources useful in the present invention include tea extract, rosemary extract, rosemary acid, coffee extract, coffee acid, turmeric extract, blueberry extract, grape extract, grape seed extract, soybean extract and mixtures and combinations thereof.

Dosage units may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about 15%, optionally from about 1% to about 10%, and optionally from about 3% to about 10% polyphenol, by weight of the dosage unit composition.

Non-limiting sources of tea extract include black tea, white tea, Oolong tea and / or green tea.

When tea extract is present, the dosage units may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about 15%, optionally from about 1% to about 10% and optionally from about 3% to about 10% of a tea extract, by weight of the dosage unit composition.

When the tea extract is green tea, the dosage units may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about 15%, optionally from about 1% to about 10% and optionally from about 3% to about 10% green tea extract, by weight of the dosage unit composition.

The components of rosemary and rosemary extract are caffeic acid and its derivatives, such as rosemary acid. These compounds have antioxidant and anti-inflammatory effects. Non-limiting sources of rosemary extract preferred for use in the present invention include rosemary.

Dosage units may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about 15%, optionally from about 1% to about 10%, and optionally from about 3% to about 10% rosemary extract, by weight of the dosage unit composition.

Dosage units may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about 15%, optionally from about 1% to about 10%, and optionally from about 3%

EP2 651 365 to about 10% rosemary acid, by weight of the dosage unit composition.

The main ingredient in the coffee extract is caffeic acid and it is believed, without being limited to theory, that it exhibits antioxidant activity.

Dosage units may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about 15%, optionally from about 1% to about 10%, and optionally from about 3% to about 10% coffee extract, by weight of the dosage unit composition.

When coffee extract is present, non-limiting sources of coffee extract include coffee beans, coffee, coffee berries, and coffee fruits. When coffee acid is present, non-limiting sources of caffeic acid preferred for use in the present invention include tea, berries, coffee beans, coffee, coffee berries, coffee fruits, rosemary extract and / or grape seed extract.

Dosage units may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about 15%, optionally from about 1% to about 10%, and optionally from about 3% to about 10% caffeic acid, by weight of the dosage unit composition.

Turmeric is a spice that contains the main active compound, which is curcumin. Curcumin is a bioactive polyphenol plant dye. Without limiting the theory, curcumin is believed to have an antioxidant effect. Turmeric is a non-limiting source of turmeric extract for use in the present invention.

Dosage units may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about 15%, optionally from about 1% to about 10%, and optionally from about 3% to about 10% of turmeric extract, by weight of the dosage unit composition.

Dosage units and systems may contain blueberry extract. Blueberry extract is rich in anthocyanins, which have antioxidant effects. Blueberry is a non-limiting source of blueberry extract.

The dosage unit may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about 15%, optionally from about 1% to about 10%, and optionally from about 3% to about 10% of blueberry extract by weight of the dosage unit composition.

EP2 651 365

Units and dosage systems may contain grape seed extract. Grape seed extract is rich in procyanides, which have antioxidant effects. Grape seed extract contains about 38.5% procyanidins. Grape seed extract is a non-limiting source of grape seed extract.

Dosage units may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about 15%, optionally from about 1% to about 10%, and optionally from about 3% to about 10% grape seed extract, by weight of the dosage unit composition.

Units and dosage systems may contain grape extract.

Grape extract is rich in resveratrol, which have antioxidant effects. Whole grapes are a non-limiting source of grape extract.

Dosage units may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about 15%, optionally from about 1% to about 10%, and optionally from about 3% to about 10% grape extract, by weight of the dosage unit composition.

Units and dosage systems may contain soybean extract. Soybean extract is rich in isoflavonoids, such as genistein and daidzein, which have various health-beneficial properties. Soybean is a non-limiting source of soy extract.

Dosage units may contain from about 0.01% to about 90%, optionally from about 0.1% to about 35%, optionally from about 1% to about 15%, optionally from about 1% to about 10%, and optionally from about 3% to about 10% soybean extract, by weight of the dosage unit composition.

Dosage units and systems may also contain active substances particularly useful for animals, non-limiting examples of which include dogs, cats, cows, rabbits and horses. Such active substances may treat and / or prevent respiratory and / or gastrointestinal disorders as well as substantially maintain and improve the overall health of the animal. Although the types of active substances described above can be used in both humans and other mammals, such as pets, the units and dosing systems of the present invention may also contain active substances particularly useful for

EP2 651 365 non-human animals. Furthermore, while the active substances described in this section are particularly useful for non-human animals, many of the active substances described in this section are also suitable for use in humans.

Non-limiting examples of such active substances include polyphosphates such as sodium hexametaphosphate (SHMP), sodium pyrophosphate, sodium tripolyphosphate, zinc chloride, copper gluconate, stannous chloride, stannous fluoride, sodium fluoride, triclosan; glucosamine hydrochloride, chondroitin sulfate, green-lip mussel extract, blue-lip mussel extract, methylsulfonylmethane (MSM); boron, boric acid, phytoestrogens, phytoandrogens, genistein, daidzein, L-carnitine, chromium picolinate, chromium tripicolinate, chromium nicotinate; glucose antimetabolites, which include 2-deoxy-D-glucose, 5thio-D-glucose, 3-O-methylglucose, anhydrous sugars, including 1,5-anhydro-D-glucitol,

2,5-anhydro-D-glucitol and 2,5-anhydro-D-mannitol, mannoheptulose, avocado extract containing mannoheptulose; fiber; prebiotics, including in particular fructooligosaccharides; acid / basic modifiers, potassium citrate, potassium chloride, calcium carbonate, calcium chloride, sodium bisulfate; eucalyptus, lavender, peppermint oil and combinations thereof.

The active substance may be administered in a single daily dose or in multiple daily doses. The active substance can be introduced into various types of dosage units as described above. Non-limiting examples of dosage units that are particularly useful for animals are candies and biscuits.

Dosage units, i.e. each candy or biscuit may contain from about 0.0001 mg to about 10 g, optionally from about 0.001 mg to about 10 g, optionally from about 0.01 mg to about 10 mg, optionally from about 1 mg to about 10 g, optionally from about 10 mg to about 5 g, optionally from about 30 mg to about 5 g, optionally from about 30 mg to about 3 g, optionally from about 300 mg to about 3 g, optionally from about 300 mg to about 1.5 g of active substance, optionally from about 30 mg to about 600 mg and optionally from about 30 mg to about 300 mg of active substance per dosage unit.

The systems can deliver from about 0.0001 mg to about 10 g, optionally from about 0.001 mg to about 10 g, optionally from about 0.01 mg to about 10 mg, optionally from about 1 mg to about 10 g, optionally from about 10 mg to about 5 g,

EP2 651 365 optionally from about 30 mg to about 5 g, optionally from about 30 mg to about 3 g, optionally from about 300 mg to about 3 g, optionally from about 300 mg to about

1.5 g of active substance, optionally from about 30 mg to about 600 mg, and optionally from about 30 mg to about 300 mg of active substance per day.

Dosage units and systems may also contain optional substances, non-limiting examples of which include amino acids, fatty acids, carotenoids, antioxidants, and combinations thereof. Optional substances may be administered in a single daily dose or in multiple daily doses.

When protein breaks down, digestion results in 22 known amino acids. Eight of them are necessary (they cannot be produced by the body), the others are endogenous (i.e. they can be produced by the body with proper nutrition).

When an amino acid is present, the amino acid is selected from the group consisting of 1-tryptophan, taurine, histidine, carnosine, alanine, cysteine, and mixtures and / or combinations thereof.

Dosage units may contain at least about 0.05%, optionally from about 0.05% to about 10%, and optionally from about 0.2% to about 5% amino acid, by weight of the composition of the dosage unit.

Dosage units may contain from about 250 mg to about 2500 mg, optionally from about 300 mg to about 2000 mg, and optionally from about 400 mg to about 1000 mg of amino acid, per dosage unit.

The systems can deliver from about 250 mg to about 2500 mg, optionally from about 300 mg to about 2000 mg, and optionally from about 400 mg to about 1000 mg of amino acid per day.

"Carotenoid" is a group of dyes found in the tissues of higher plants, algae, bacteria and fungi. When the carotenoid is present, the carotenoid is selected from the group consisting of lutein, astaxanthin, zeaxanthin, bixin, lycopene, beta-carotene and mixtures thereof and / or combination.

Dosage units may contain at least about 0.01%, optionally from about 0.01% to about 20%, and optionally from about 0.05% to about 10% of the carotenoid, by weight of the dosage unit composition.

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Dosage units and systems may contain antioxidant in addition to vitamins, plant-derived substances, elements and carotenoids described above, which have antioxidant properties. The antioxidant used herein is an enzyme or other organic molecule that can counteract the harmful effects of oxygen on tissues.

When an antioxidant is present, non-limiting examples of such antioxidants include tocopherols (vitamin E, described above), vitamin C (described above), vitamin A (described above), substances of plant origin (described above), carotenoids (described above), selenium (described above) above), CoQ10 and mixtures and / or combinations thereof.

The dosage units and systems of the present invention may contain coenzyme Q10 (CoQ10). Dosage units contain at least about 0.01%, optionally from about 0.01% to about 10%, and optionally from about 0.2% to about 5% of coenzyme Q10, by weight of the dosage unit composition.

Dosage units may contain from about 1 mg to about 400 mg, optionally from about 2 mg to about 400 mg, and optionally from about 3 mg to about 300 mg of coenzyme Q10, per dosage unit.

Systems may deliver from about 1 mg to about 400 mg, optionally from about 2 mg to about 400 mg, and optionally from about 3 mg to about 300 mg of coenzyme Q10, per day.

Units and dosage systems may contain fatty acid.

Long chain fatty acids play a key role in the metabolism of arachidonic acid, which could be useful in modulating pain sensation and inflammation. Currently, long chain fatty acids such as omega-6 fatty acids are used for their antioxidant and immunological health benefits.

Non-limiting examples of preferred long chain fatty acids include alpha-linoleic acid, gamma-linolenic acid, linoleic acid, eicosapentaenoic acid and docosahexaenoic acid. Fish oils are a preferred source of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

Dosage units contain from at least about 0.05%, optionally at least about 0.1% and optionally at least 0.15% DHA, by weight of the dosage unit composition.

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Dosage units may contain from at least about 0.05%, optionally at least about 0.1%, and optionally at least 0.15% EPA, by weight of the dosage unit composition.

Dosage units may also contain an excipient, as will be understood by those skilled in the art with regard to the preparation of various types of dosage units. Non-limiting examples of excipients include microcrystalline cellulose, dicalcium phosphate, stearic acid, magnesium stearate, corn starch, lactose, croscarmellose sodium, sodium starch glycolate, polyvinylpyrrolidone, gelatin and combinations thereof.

Dosage units may contain from about 1% to about 99%, optionally from about 2% to about 70%, optionally from about 3% to about 50%, optionally from about 5% to about 30%, and optionally from about 6% to about 25% excipient, by weight dosage unit composition.

Dosage units may also contain one or more of a wide range of optional ingredients and processing aids, as will be understood by those skilled in the art with regard to the preparation of various dosage forms. Non-limiting examples of optional ingredients include plasticizers, dyes, flavors, sweeteners, buffering agents, lubricants, carriers, pH regulators, natural ingredients, stabilizers, biological additives such as enzymes (including proteases and lipases), additives chemical, cooling agents, chelating agents, denaturing agents, astringents, emulsifiers, painkillers for external use, fragrances, moisture absorbers, opacifiers (such as zinc oxide and titanium dioxide), anti-foaming agents (such as silicone), preservatives (such as butylated hydroxytoluene (BHT) and butylated hydroxyanisole (BHA), propyl gallate, benzalkonium chloride, EDTA, benzyl alcohol , potassium sorbate, parabens and mixtures thereof), reducing agents, solvents, hydrotropes, dissolving agents, suspending agents (non-surfactants), solvents, viscosity enhancers (aqueous and anhydrous), masking agents, keratolytic agents and the like, and mixtures and / or combinations thereof.

Generally, unless otherwise specified herein, dosage units may contain from about 0.001% to about 99%, optionally

EP2 651 365 from about 0.01% to about 80%, optionally from about 0.01% to about 50%, and optionally from about 0.01% to about 10% of optional ingredients, by weight of the dosage unit composition.

The cards and blister systems described above provide intuitive dosing tips that help consumers take multiple unit doses at different times, for example during the day. Blister cards can be sized to fit easily into someone's pocket or purse. If not all unit doses are accepted, the information provided by the blister cards may be an indication to the consumer when to take the remaining unit doses.

It should be noted that terms such as "preferably", "essentially", "commonly" and "usually" are not used herein to limit the scope of the claimed embodiments or to suggest that certain features are relevant, necessary, or even important for certain structures or functions. Instead, these terms are only intended to capture alternative or additional features that may or may not be used in a particular embodiment.

For the purposes of describing and identifying various embodiments, it should further be noted that the term "essentially" is used herein to represent the inherent degree of uncertainty that can be attributed to a quantitative comparison, size, measurement or other representation. The term "essentially" is also used herein to describe the extent to which a quantitative representation may differ from the values ​​expressed without changing the basic function of the subject matter.

Dimensions and sizes disclosed here should not be taken as strictly limited to the numerical values ​​quoted herein. However, unless otherwise specified, each dimension mentioned is intended to mean both a quoted value and a functionally equivalent range around that value.

For example, the dimension "40 mm" is intended to mean "about 40 mm".

Citing any document does not imply that it is prior art to any invention disclosed or claimed herein, or that it alone teaches, suggests or discloses such an invention alone or in any combination with any of the other references.

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In addition, if any meaning or definition of an expression in this document does not match the meaning or definition of the same expression in a document incorporated by reference, then the meaning or definition of the expression should be as given in this document.

While particular embodiments of the present invention have been shown and described, it is clear to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. Therefore, it is intended to include all such changes and modifications within the scope of the present invention in the appended claims.

EP2 651 365