Skin protectant spray compositions

SKIN PROTECTIVE SPRAY COMPOSITIONS BACKGROUND OF THE INVENTION

Technical Field

This invention relates to topical formulations and, more particularly, to topical sprayable skin-protective formulations.

Background

Certain drugs and other substances are often applied to human skin to protect it from harmful stimuli.

The US Food and Drug Administration (FDA) has in the past defined a skin protectant as a drug that protects damaged or exposed mucous membrane or skin surfaces from harmful or irritating stimuli (21 CFR _ 347.3 (1983)). Thus, a skin protectant can be used to protect and/or treat the skin in connection with various indications including diaper rash; minor burns; cuts; scratches; sunburn; cutting, cracking, fissuring or dryness of the skin or lips; skin irritation; and oozing and/or oozing from the skin due to contact with plants of the genus Rhus, poison ivy, poison oak, and/or poison sumac.

Children's skin is known to be very sensitive, 25 particularly to chemicals. A common skin problem in children is diaper rash, more commonly called diaper rash. Diaper rash has been defined by the FDA as an inflammatory condition of the skin in the diaper area 30 (perineum, buttocks, lower abdomen, and inner thighs) due to one or more of the following factors: moisture, occlusion , friction, continued contact with urine, feces, or both, or mechanical or chemical irritation (21 CFR _ 347.3 (1990)), and this definition will be used in this document. The FDA has also indicated that mild diaper rash appears as a simple rash and that more serious conditions may be accompanied by papules, vesicles, oozing, and ulceration. Adults (for example, incontinent adults) can also get diaper rash.

Treatment strategies for diaper rash include removing the source of irritation, reducing the immediate skin reaction, relieving discomfort, and preventing secondary infection. Many products used in the treatment of diaper rash are designed to provide a barrier between the skin and bodily debris. Known barrier ingredients include zinc oxide and petroleum jelly. Barrier products that

<img file="ECSP014064A_D0001.tif" />

<img file="ECSP014064A_D0002.tif" />

They contain oily substances such as Vaseline, they can feel greasy, they can be difficult to apply due to their high viscosity and they can be difficult to remove from the hands that apply the products or from the baby's skin.

Some people may find cleaning these products off baby's hands and skin a time consuming, messy and inconvenient task.

The FDA will allow claims that the following substances are useful as skin protectants 10 provided, among other things, those substances are used at FDA-specified concentration levels: mineral oil, dimethicone, zinc oxide, allantoin, calamine, kaolin, petroleum jelly, white petroleum jelly, cod liver oil, lanolin, talc, topical starch, aluminum hydroxide gel, cocoa butter, glycerin, liver oil shark, zinc acetate and zinc carbonate, all of which are referred to herein as active ingredients to protect the skin (21 CFR _ 347.10 (1983 and

1990)). As used herein, the terms, skin protection and human skin protection are synonymous and each includes the protection and/or treatment of the skin in connection with various indications involving the skin, including diaper rash; minor burns; cuts; scratches; sunburn; cutting, 25 cracking, fissuring or dryness of the skin or lips; skin irritation; and skin oozing and/or oozing from contact with Rhus ivy, poison oak, and/or poison sumac.

The FDA will allow claims that the following 30 substances are useful for the treatment of diaper rashes provided, among other things, those substances are used at FDA-specified concentration levels: mineral oil, dimethicone, zinc oxide, allantoin, calamine, kaolin, petroleum jelly, white petroleum jelly, cod liver oil, lanolin, talc, and topical starch, all of which are referred to herein as active ingredients for the treatment of diaper rash (21 cfr _ 347.10 (1983 and 1990)). For example, assuming all other requirements are met, the FDA 40 will allow a claim that a dimethicone-containing composition is useful for treating diaper rash if the dimethicone concentration is 1%w (weight percent) to 30%w . A similar statement can be made for a composition containing zinc oxide if the zinc oxide concentration is 1%w to 40%w. A similar statement can be made for a composition containing oil

-K -vtfid' &gt;7 í&lt;&gt;' mineral if the concentration of mineral oil is from 50%p to 100%p. As used herein, the term "diaper rash treatment" includes the treatment of an existing diaper rash, the prevention of a diaper rash, or both.

<img file="ECSP014064A_D0003.tif" />

Compositions that can come into contact with the

<td colspan="4">skin and may contain zinc oxide</td><td colspan="2" rowspan="2">and/or mineral oil and/or dimethicone or others</td>

<td colspan="3">silicon dioxide</td><td>(silica) and/or</td>

<td></td><td>compounds</td><td>of sylicon,</td><td colspan="2">may be some</td><td>of them in</td>

<td> 10</td><td>form of</td><td>sprays or</td><td colspan="3">spray compositions and</td>

<td></td><td colspan="2">being able to use some</td><td>of them for</td><td>treat the</td><td>eruption of</td>

<td></td><td colspan="2">diaper, include the</td><td>compositions</td><td colspan="2">mentioned in the</td>

<td></td><td>patents</td><td>Of states</td><td>United Nos.</td><td>Re.33.107,</td><td> 2.843.522,</td>

<td></td><td> 3.770.648,</td><td> 3.935.862,</td><td> 4.043.077,</td><td> 4.196.218,</td><td> 4.273.786,</td>

<td> 15</td><td> 4.278.658,</td><td> 4.329.366,</td><td> 4.389.418,</td><td> 4.514.383,</td><td> 4.556.560,</td>

<td></td><td> 4.569.839,</td><td> 4.574.082,</td><td> 4.672.074,</td><td> 4.725.438,</td><td> 4.800.076,</td>

<td></td><td> 4.816.254,</td><td> 4.842.593,</td><td> 4.847.071,</td><td> 4.911.932,</td><td> 4.933.330,</td>

<td></td><td> 4.938.960,</td><td> 4.996.238,</td><td> 4.996.239,</td><td> 5.043.359,</td><td> 5.085.856,</td>

<td></td><td> 5.137.714,</td><td> 5.208.031,</td><td> 5.210.102,</td><td> 5.232.691,</td><td> 5.234.689,</td>

<td> 20</td><td> 5.266.318,</td><td> 5.362.488,</td><td> 5.389.204,</td><td> 5.436.007,</td><td> 5.527.519,</td>

<td></td><td> 5.543.135,</td><td> 5.545.673,</td><td> 5.558.872,</td><td> 5.573.753,</td><td> 5.576.006,</td>

<td></td><td> 5.603.863,</td><td> 5.616.331,</td><td> 5.635.191,</td><td> 5.643.588,</td><td> 5.652.274,</td>

<td></td><td> 5.662.937,</td><td> 5.665.426,</td><td> 5.730.993,</td><td> 5.733.895,</td><td> 5.744.146,</td>

<td></td><td> 5.756.082,</td><td> 5.756.110,</td><td> 5,762.945,</td><td> 5.776.440,</td><td> 5.834.290,</td>

<td> 25</td><td> 5.861.143,</td><td> 5.861.144,</td><td> 5.861.146,</td><td> 5.863.522,</td><td> 5.869.061,</td>

<td></td><td> 5.869.062,</td><td> 5.869.071,</td><td> 5.874.094,</td><td> 5.885.599,</td><td> 5.914.101,</td>

<td></td><td> 5.939.053,</td><td> 5.945.211,</td><td> 5.958.397,</td><td> 5.961.961,</td><td> 5.962.441,</td>

<td></td><td> 5.965.137,</td><td> 5.965.610,</td><td>5,968,531 and 5</td><td> .972.359.</td><td>(All these</td>

<td></td><td>documents</td><td>and any</td><td>other document</td><td>i described</td><td>or mentioned</td>

<td> 30</td><td colspan="2">or identified from another</td><td>way in this</td><td>document</td><td>is incorporated</td>

in its entirety for all purposes).

<td>The</td><td>compositions</td><td colspan="2">containing rust</td><td>of zinc that</td>

<td colspan="3">can come into contact with</td><td>the skin</td><td>include the</td>

<td colspan="2">mentioned in the</td><td>patents of</td><td>state</td><td>United Nos.</td>

<td> 2.843.522,</td><td> 3.770.648,</td><td> 4.034.077,</td><td> 4.278.658</td><td> , 4.389.418,</td>

<td> 4.556.560,</td><td> 4.569.839,</td><td> 4.672.074,</td><td> 4.816.254</td><td> , 4.911.932,</td>

<td> 4.933.330,</td><td> 5.085.856,</td><td> 5.208.031,</td><td> 5.232.691</td><td> , 5.527.519,</td>

<td> 5.543.135,</td><td> 5.545.673,</td><td> 5.573.753,</td><td> 5,603.863</td><td> , 5.616.331,</td>

<td> 5.652.274,</td><td> 5.662.937,</td><td> 5.665.426,</td><td> 5.730.993</td><td> , 5.773.895,</td>

<td> 5.744.146,</td><td> 5.756.110,</td><td> 5.762.945,</td><td> 5.834.290</td><td> , 5.861.143,</td>

<td> 5.861.144,</td><td> 5.861.146,</td><td> 5.863.522,</td><td> 5.869.062</td><td> , 5.874.094,</td>

<td> 5.885.599,</td><td> 5.914.101,</td><td> 5.939.053,</td><td> 5.945.211</td><td> , 5.961.961,</td>

<td> 5.962.441,</td><td> 5.965.610, 5,</td><td colspan="2">,968,531 and 5,972,359.</td><td></td>

Some of the zinc oxide-containing compositions can be sprayed (with or without a propellant). See, for example, US Patent Nos. 3,770,648,

4.278.658,

5.861.143,

5.939.053,

5.652.274,

5.861.146,

5.733.895,

5.863.522,

5.834.290,

5.885.599,

4.933.330,

5.861.144,

5,945,211, 5,962,441, 5,965,610 and 5,972,359.

Some of the compositions containing zinc oxide may contain small particles of zinc oxide (for which

5.573.753,

5.861.143,

5,961,961 and 5,972,359.

example, under US Patents 5,603,863, 5,861,144, micrometer). See, for example, United Nos.

5.616.331,

5.861.146,

5.527.519,

5.756.110,

5.945.211,

5.543.135,

5.730.993,

5.914.101,

Topical compositions for the treatment of diaper rash containing zinc oxide include DESITIN® Ointment and DESITIN® Creamy Ointment, both available from Pfizer Inc., the assignee of the present application. DESITIN® Ointment contains approximately 40%w zinc oxide and other ingredients, including white petrolatum, cod liver oil, lanolin, talc and approximately 5%w water. DESITIN® Cream Ointment contains approximately 10%w zinc oxide and other ingredients including mineral oil, mineral wax, dimethicone, cyclomethicone, white petrolatum, white wax and more than 30%w water.

Other diaper rash treatment, incontinence/dermatitis rash treatment and baby treatment compositions include those mentioned in the

<td>patents of</td><td colspan="2">United States Us</td><td>. Re.33.107,</td><td> 2.843.522,</td>

<td> 3.770.648,</td><td> 3.935.862,</td><td> 4.034.077,</td><td> 4.273.786,</td><td> 4.329.366,</td>

<td> 4.556.560,</td><td> 4.816.254,</td><td> 4.842.593,</td><td> 4.911.932,</td><td> 4.996.238,</td>

<td> 4.996.239,</td><td> 5.362.488,</td><td> 5.436.007,</td><td> 5.576.006,</td><td> 5.558.872,</td>

<td> 5.635.191,</td><td> 5.643.588,</td><td> 5.652.274,</td><td> 5.762.945,</td><td> 5.834.290,</td>

<td>5,869,071 and í</td><td> 5.945.211.</td><td></td><td></td><td></td>

<td>Some</td><td>of this</td><td colspan="3">treatment compositions</td>

<td>rashes</td><td>diaper</td><td>, of</td><td>rashes</td><td>due to</td>

Incontinence/Dermatitis and Baby Treatment may form a film when applied topically and may be resistant to moisture. See, for example, US Patent Nos. 4,996,238 (column 2, line 20 et seq.) and 4,996,239 (column 22, line 40 et seq.).

Some of these diaper rash treatment, incontinence/dermatitis rash treatment and baby treatment compositions may contain film-forming agents. See, for example, US Patent Nos. 4,996,238 (column 2, line 42 et seq.), 4,996,239 (column 2, line 63 et seq.), 5,635,191 (column 18, line 34) and

5,643,588 (column 18, line 47).

Some of these diaper rashes, incontinence/dermatitis and baby treatment compositions may or treatment compositions for rashes due to a

(with the Patents

3.935.862,

5,576,006, be sprayable example, 3,770,648, 5,436,007,

5,869,071 and 5,945,211.

without a propellant). from the United States 4,329,366, 5,643,588,

state

4.273.786,

5.635.191,

See, for

Re.33.107,

4.842.593, 5.652.274,

US Patent No. Re.33,107 refers to spray compositions that may contain mineral oil for treating skin conditions such as dermatitis.

United States Patent No. 3,770,648, assigned by title to Bristol-Myers Company, relates to substantially non-aqueous, fast breaking aerosol foaming compositions containing silicone compounds (for example, dimethyl silicone fluids ), foamable organic liquids (eg mineral oil) and a high vapor pressure propellant system (eg fluorocarbons). Example 2 of the patent refers to what is called DESITIN® baby foam, which contains zinc oxide (approximately 4.2%w), mineral oil (approximately 71.7%w), a silicone and FREON. 12 as a fluorocarbon propellant.

US Patent Nos. 3,935,862 and 4,273,786 refer to compositions containing amino acid compounds to inhibit ammonia formation and thereby treat diaper rash. The compositions may contain solid diluents such as starch and talc and may also contain silicone type fluids such as polysiloxane fluid. Although some of the non-sprayable compositions illustrated in the patents refer to mineral oil, the only sprayable composition (Example H) contains micropulverized talc, an amino acid salt, perfume, anhydrous ethanol, isopropyl myristate, and two FREON propellants.

US Patent No. 4,329,366 refers to compositions containing acylaminophenols that can be used to treat various conditions, including diaper rash. Although some of the illustrated non-spray formulations refer to mineral oil, both of the sprayable formulations (Formulations F and L) use alcohol and propellants and at least one of them (Formulation F) contains water.

United States Patent No. 4,842,593 refers to

<img file="ECSP014064A_D0004.tif" />

a pH control system that can be sprayed on a used article to prevent or reduce diaper rash. The fibers of the article can be impregnated with silica.

US Patent No. 5,436,007 refers to a sprayable diaper rash lotion containing dimethicone (eg, 1%w to 30%w), water (eg, 50%w to 95%w) and an emulsifier (for example, from 1%w to 10%w). The patent also relates to io a diaper rash cream which may contain a linear polydimethylsiloxane (eg 20wt%), a light mineral oil (eg 4wt%), emulsifier (eg a 8%w) and water (for example, more than 40%w). Stearic acid, which is said to function as a thickener, and aloe may also be used in the lotion and cream. See, for example, from column 7, line 6, to column 10, line

26.

US Patent No. 5,576,006 refers to antibacterial compositions that can be used to deodorize footwear and to treat diaper rash.

Although shoe deodorant compositions can be spray-on, it appears that compositions intended for use on babies are body preparations and powders that may contain talc (column 3, lines 4725-63 and Example 3). The illustrated spray compositions contain water.

United States Patent Nos. 5,635,191 and 5,643,588 refer to a diaper having the top layer coated with a composition containing emollients (such as mineral oil, petrolatum or mineral wax, and polysiloxanes) and other ingredients ( such as viscosity modifiers and film formers). The composition can be sprayed on the top coat. According to the patents, the composition of the top layer 35 of the diaper is transferred to the wearer's skin and those top layers provide BM [bowel movement] cleansing and protective or therapeutic lotion coating benefits (U.S. Patent No. 5,635,191, column 2, line 64, to column 3, line 52; and 40 US Patent No. 5,643,588, column 2, line 62 to column 3, line 51). The composition is solid or semi-solid at 20°C (US Patent No. 5,635,191, column 9, lines 35-67; ​​and US Patent No. 5,643,588, column 9, line 39, to column 10, line 4) and 45 is substantially devoid of water (United States Patent

No. 5,635,191, column 10, lines 43-54, and Patent of

48-59).

refers to wounds. It lines 31-49; lines 5-26; and column 4. These compositions Al (for see

Some of the mineral oil and vitamin E compositions (see fewer examples, column 42, may contain, for example,

US No. 5,643,588, column 10, lines US Patent No. 5,652,274 therapeutic compositions for the healing of describe compositions for the treatment of diaper rash, for example, in column 11, column 15, lines 39-61; column 26, 138, line 52, to column 145, line may contain zinc oxide, compositions may be sprayed formulations of Embodiment One; line 26). Vaseline, column 66, lines 35-49).

US Patent No. 5,869,071 refers to a spray composition for incontinence patients that cleanses, hydrates, and leaves a protective petroleum jelly barrier against moisture and irritants in a single step (column 1, lines 58-63 ) . The composition is said to be an emulsion of water and petroleum jelly (or petrolatum) and may contain dimethicone, cyclomethicone, mineral oil, vitamin E and aloe.

US Patent No. 5,945,211 refers to a composite material to which zinc oxide particles are adhered. The composite material can be a diaper and the zinc oxide can be deposited on the composite material from an aqueous medium (for example, by spraying a zinc oxide slurry).

Sprayable compositions (with or without propellant) that may come into contact with the skin and may contain dimethicone or other silicon compounds include those mentioned in US Pat. NOS. 3,770,648, 3,935,862, 4,273,786, 4,514,383, 4,933,330, 5,635,191, 5,861,143, 5,885,599, one that

3.770.648, 3.935.862, 4.273.786,

5.266.318,

5.733.895,

5.861.146,

4.514.383

5.389.204,

5.776.440,

5.863.522,

4.847.071,

5.436.007,

5.834.290,

5,869,071, (dioxide Patents 4,996,238, 5,543,135, 5,756,082, 5,861,146, 5,968,531 are

patents of

5.137.714,

5.643.588,

5,861,144, 5,939,053, 5,962,441, 5,965,610 and 5,972,359.

The compositions of silicon) of United

4.996.239,

5.573.753,

5.756.110,

5.863.522,

5.972.359.

as

United States Nos. 4,996,238 and 4,996,239.

and tools that contain some form of silica include

United Nos.

5.137.714,

5.603.863,

5.834.290,

5.885.599,

It is said that thickeners.

mentioned

4.574.082,

5.208.031,

5.616.331,

5.861.143,

5,914,101, some forms

See, in the

4.800.076,

5.527.519,

5.733.895,

5,861,144, 5,939,053, of silica for example, the

2O

3/- Me and 0/1/ example,

5.527.519,

5.773.895,

5.861.146,

5,968,531 and US Patents

5.543.135,

5.756.110,

5.863.522,

5.972.359.

contain zinc oxide í of States 5,573,753, 5,834,290, 5,885,599. United Nos.

5.603.863,

5.861.143,

5,914,101, which contain sprayable silica. See, United Nos. 5,137,714, 5,861,144, 5,861,146,

Some of these compositions that contain some form of silica can also See, for 5,208,031, 5,616,331, 5,861,144, 5,939,053,

Some of these compositions (with or without zinc oxide) can be, for example, US Patents 5,733,895, 5,834,290. 5,861,143,

5,863,522, 5,885,599, 5,939,053 and 5,972,359.

Some spray compositions may contain aloe and/or a form of vitamin E. See, for example, US Patent Nos. 4,847,071, 5,436,007, 5,861,143, 5,861,144, 5,861,146,

5,885,599, 5,965,137, compositions containing aloe and/or a formula may be for the treatment of rash incontinence/dermatitis. See, for example, US Nos. 5,436,007 and 5,869,071.

Compositions containing (a) mineral oil or (c) dimethicone or other those mentioned in 3,770,648, 4,933,330, 5,603,863,

5.744.146,

5.861.146, 5.961.961,

5,266,318, 5,869,071, 5,965,610 and 5,972,359. Some of the vitamin E diapers and/or the Patents of: United States

4.569.839,

5.232.691,

5.730.993,

5.861.143,

5.914.101,

5.972.359.

4.389.418,

5,085.856,

5.616.331,

5.756.110,

5.863.522,

5.962.441,

And sprayable (with Patents 5,733,895, 5,863,522,

United Nos.

4.911.932,

5.543.135,

5.773.895,

5.861.144,

5.939.053,

Some of these compositions may or may not have a United

5.834.290,

5.885.599,

Some of these compositions can propellant). See, United Nos.

5.861.143,

5,939,053, for

3.770.648,

5.861.144,

5,962,441, Petrolatum, (b) zinc oxide and silicone ingredient, include Patents 4,556,560, 5,208,031, 5,665,426, 5,834,290, 5,885,599, 5,965,610 exemplify, 4,933,330, 5,861 .146, 5,965,610 and 5,972,359.

be for the treatment of diaper rash. See, for example, US Patent Nos. 4,556,560 and 4,911,932.

Some of the compositions containing (a) mineral oil or petrolatum, (b) zinc oxide, and (c) dimethicone or other silicone ingredient may also contain silica. See, for 5,208,031, 5,756,110, 5,863,522, example,

5.543.135,

5.834.290,

5,885,599, the Patents

5.603.863,

5.861.143,

5,914,101, United States Nos.

5.616.331,

5.861.144,

5,939,053 and

5.733.895,

5.861.146,

5.972.359.

JL- /'«Λ 7 ÍW

Some of these compositions may be sprayable (with or without a propellant). See, for example, US Patent Nos. 5,733,895, 5,834,290, 5,861,143,

5,861,144, 5,861,146, 5,863,522, 5,885,599, 5,939,053 and

5.972.359.

Some of the compositions containing (a) mineral oil or petrolatum, (b) zinc oxide, and (c) dimethicone or other silicone ingredient may also contain wax.

<td>See, for</td><td colspan="2">example, patents</td><td colspan="2">of United States Nos.</td>

<td> 10 4.389.418,</td><td> 4.556.560,</td><td> 4.569.839,</td><td> 4.911.932,</td><td> 4.933.330,</td>

<td> 5.085.856,</td><td> 5.208.031,</td><td> 5.232.691,</td><td> 5.616.331,</td><td> 5.665.426,</td>

<td> 5.730.993,</td><td> 5.733.895,</td><td> 5.744.146,</td><td> 5.834.290,</td><td> 5.863.522,</td>

<td>5,939,053 and</td><td colspan="2">5,961,961. Some of</td><td colspan="2">compositions can</td>

be sprayable (with or without a propellant). See, for example, US Patent Nos. 4,933,330, 5,733,895, 5,834,290, 5,863,522, and 5,939,053.

Despite all the work done in this technical area, there remains a need for a safe and effective liquid skin protective composition that is liquid, hydrophobic, substantially anhydrous and can be applied directly to the skin in a quick and easy manner. easy and without getting your hands dirty with the composition, and that it does not move after it has been applied to the skin. In addition, a need still exists for such a composition that can be applied to the skin without the need to use high pressure, such as that provided by a propellant in an aerosol can. Furthermore, there remains a need for a composition that meets all of these criteria and that can be used for the treatment of diaper rash.

SUMMARY OF THE INVENTION

A composition has now been developed which can satisfy some or all of these needs and which provides other advantages which will be apparent to those skilled in the art. In general terms, the composition of this invention is a skin protective composition comprising:

(a) at least about 0.001 wt% of at least one active ingredient to protect the skin;

(b) at least about 0.001 wt% of at least one rheology modifier; and (c) a vehicle;

the substantially anhydrous, hydrophobic, liquid composition being pumpable for spraying, being designed to be sprayed onto the skin of an infant or other human to protect the skin, having adequate adhesion to the skin and resisting displacement.

Another aspect of the invention refers to a skin protective composition comprising:

(a) at least about 0.001 wt% of at least one active ingredient to protect the skin;

(b) at least about 0.001 wt% of a rheology modifier that is an association thickener and optionally at least about 0.001 wt% of at least one other rheology modifier; and io (c) a vehicle;

the substantially anhydrous, hydrophobic, liquid composition being pumpable for spraying and being designed to be sprayed onto the skin of an infant or other human to protect the skin, having adequate adhesion to the skin and resisting displacement.

Another aspect of the invention refers to a skin protective composition comprising:

(a) at least about 0.001 wt% of at least one active ingredient to protect the skin;

(b) at least about 0.001 wt% of a rheology modifier that is an association thickener and optionally at least about 0.001 wt% of at least one other rheology modifier;

(c) at least about 0.001 wt% of at least one film-forming agent; and (d) a vehicle;

the substantially anhydrous, hydrophobic, liquid composition being pumpable for spraying, being designed to be sprayed onto the skin of an infant or other human being to protect the skin, having adequate adhesion to the skin and resisting displacement.

Another aspect of the invention refers to a skin protective composition comprising:

(a) at least about 0.1 wt% of at least one active ingredient to protect the skin;

(b) at least about 0.1 wt% of a rheology modifier that is an association thickener and optionally at least about 0.1 wt% of at least one other rheology modifier;

(c) at least about 0.1 wt% of at least one polymeric film-forming agent; and (d) A vehicle;

the composition being liquid, hydrophobic, substantially anhydrous, pumpable for spraying,

<img file="ECSP014064A_D0005.tif" />

<img file="ECSP014064A_D0006.tif" />

being designed to be sprayed on the skin of an infant or other human being to protect the skin, having adequate adhesion to the skin and resisting displacement.

Another aspect of the invention refers to a skin protective composition comprising:

(a) at least about 0.001 wt% of at least one active ingredient to protect the skin;

(b) at least about 0.001 wt% of at least one rheology modifier that is an association thickener and optionally at least about 0.001 wt% of at least one other rheology modifier that is a wax;

(c) at least about 0.001 wt% of at least one polymeric film-forming agent selected from the group consisting of silicon-containing polymers and synthetic waxes; and (d) a vehicle;

the substantially anhydrous, hydrophobic, liquid composition being pumpable for spraying, being designed to be sprayed onto the skin of an infant or other human being to protect the skin, having adequate adhesion to the skin and resisting displacement.

Another aspect of the invention relates to a diaper rash composition comprising:

(a) at least about 0.1 wt% of at least one active ingredient for treating diaper rash;

(b) at least about 0.1 wt% of at least one rheology modifier;

(c) at least about 0.1 wt% of at least one film-forming agent; and (d) a vehicle;

the liquid, hydrophobic, substantially anhydrous, pumpable sprayable composition being designed to be sprayed onto the skin of an infant or other human to treat diaper rash, having adequate adherence to the skin and resisting displacement.

Another aspect of the invention relates to a diaper rash composition comprising:

(a) at least about 1% wt of dimethicone;

(b) at least about 0.5 wt% of at least one rheology modifier selected from the group consisting of association thickeners and waxes;

(c) at least about 0.2 wt% of at least one polymeric film-forming agent; and

-3JjteíJv and iM

4Ó (d) a vehicle;

the liquid, hydrophobic, substantially anhydrous, pumpable sprayable composition being designed to be sprayed onto the skin of an infant or other human to treat diaper rash, having adequate adherence to the skin and resisting displacement.

Another aspect of the invention relates to a diaper rash composition comprising:

(a) at least about 1% wt of dimethicone;

(b) at least about 1 wt% zinc oxide;

(c) at least about 1 wt% wax;

(d) at least about 1 wt% of an association thickener;

(e) at least about 0.2 wt% of at least one polymeric film-forming agent; and (f) a vehicle selected from the group consisting of mineral oil and mineral oil substitutes;

the liquid, hydrophobic, substantially anhydrous, pumpable sprayable composition being designed to be sprayed onto the skin of an infant or other human to treat diaper rash, having adequate adherence to the skin and resisting displacement.

Another aspect of the invention relates to a diaper rash composition comprising:

(a) at least about 1% wt of dimethicone;

(b) at least about 1% wt of mineral wax;

(c) at least about 0.5 wt% silica;

(d) at least about 0.1 wt% of a silicon-containing polymeric film-forming agent;

(e) at least about 0.1 wt% of a synthetic wax film-forming polymeric agent;

(f) at least about 2 wt% cyclomethicone;

(g) at least about 2 wt% isohexadecane; and (h) at least about 50%w mineral oil;

the substantially anhydrous, hydrophobic, liquid composition being pumpable for spraying, being designed to be sprayed onto the skin of an infant or other human being to treat diaper rash, having adequate adherence to the skin and resisting displacement.

Another aspect of the invention relates to a diaper rash composition comprising:

and rfli about 0.8%w to (a) about 1.2%w of dimethicone;

(b) about mineral wax;

(c) about 2.8 wt% silica;

(d) about 1.2 wt% of a polymeric agent contains silicon;

(e) 2.4%w of a synthetic;

(f) from 4% to approximately one

6%p a about a polymeric agent 1.8%p about a a

0.8%pa approximately film-forming wax film-forming 1.6%pa approximately a

7,2%

5.2%p %p approximately approximately approximately a a a

<td colspan="2">(to)</td><td>to the</td><td>less</td>

<td></td><td>b)</td><td>to the</td><td>less</td>

<td></td><td>(c)</td><td>to the</td><td>less</td>

<td> 30</td><td>(d)</td><td>to the</td><td>less</td>

<td></td><td>(and)</td><td>to the</td><td>less</td>

<td></td><td>polymeric</td><td colspan="2">trainer</td>

<td></td><td>(F)</td><td>to the</td><td>less</td>

<td></td><td>polymeric</td><td colspan="2">trainer</td>

<td> 35</td><td>(g)</td><td>to the</td><td>less</td>

<td></td><td>(h)</td><td>to the</td><td>less</td>

and approximately

10.8%w of cyclomethicone;

(g) of approximately

7.8%w isohexadecane; and (h) of approximately

85%w ​​mineral oil;

the substantially anhydrous, hydrophobic, liquid composition being pumpable for spraying, being designed to be sprayed onto the skin of an infant or other human being to treat diaper rash, having adequate adherence to the skin and resisting displacement.

Another aspect of the invention is directed to a diaper rash composition comprising: about 1% dimethicone; about 1% zinc oxide; about a l%w of mineral wax; approximately 0.5%w of silicon;

about 0.1 wt% of a silicon-containing film agent;

about 0.1 wt% of a synthetic wax film agent;

about 2%w cyclomethicone; about 2%w isohexadecane;

(i) at least about 50%w mineral oil;

the substantially anhydrous, hydrophobic, liquid composition being pumpable for spraying, being designed to be sprayed onto the skin of an infant or other human being to treat diaper rash, having adequate adherence to the skin and resisting displacement.

Another aspect of the invention relates to a

--jieido and fidf diaper rash composition comprising:

<td rowspan="2">(a) 1.2%w of (b)</td><td colspan="2">of about dimethicone;</td><td rowspan="2">a a</td><td colspan="4">0.8%pa about a</td>

<td>of</td><td>approximately</td><td>8%p</td><td>to</td><td>approximately</td><td>a</td>

<td colspan="2">5 12%w of oxide</td><td>of zinc;</td><td></td><td></td><td></td><td></td><td></td>

<td>(c)</td><td>of</td><td>approximately</td><td>a</td><td> 1,8%</td><td>to</td><td>approximately</td><td>a</td>

<td colspan="2">2.7% wax:</td><td>mineral;</td><td></td><td></td><td></td><td></td><td></td>

<td>(d)</td><td>of</td><td>approximately</td><td>a</td><td>1,7%p</td><td>to</td><td>approximately</td><td>a</td>

<td>2.5%p of</td><td colspan="2">silica;</td><td></td><td></td><td></td><td></td><td></td>

<td>i (e)</td><td>of</td><td>approximately</td><td>a</td><td> 0,4%</td><td>to</td><td>approximately</td><td>a</td>

<td>0.6%p of</td><td>a</td><td colspan="2">polymeric agent</td><td colspan="3">film maker</td><td>that</td>

<td>contains</td><td colspan="2">silicon;</td><td></td><td></td><td></td><td></td><td></td>

<td>(F)</td><td>of</td><td>approximately</td><td>a</td><td>l.0%p</td><td>to</td><td>approximately</td><td>a</td>

1.6%w of a synthetic wax film-forming polymeric agent;

<td>(g)</td><td>of</td><td>approximately</td><td>a</td><td>6.8% to</td><td>approximately</td><td>a</td>

<td>10.2% of</td><td colspan="2">cyclomethicone;</td><td></td><td></td><td></td><td></td>

<td>(h)</td><td>of</td><td>approximately</td><td>a</td><td>4.5%pa</td><td>approximately</td><td>a</td>

<td>6.7% of</td><td colspan="2">isohexadecane; and</td><td></td><td></td><td></td><td></td>

<td>(Yo)</td><td>of</td><td>approximately</td><td>a</td><td>53%pa</td><td>approximately</td><td>a</td>

80%w mineral oil;

the liquid, hydrophobic, substantially anhydrous, pumpable sprayable composition being designed to be sprayed onto the skin of an infant or other human to treat diaper rash, having adequate adherence to the skin and resisting displacement.

Another aspect of this invention relates to a portable spray pump dispenser containing 30 and spraying the composition of this invention.

Another aspect of this invention relates to a process for protecting human skin that comprises applying the composition of this invention to human skin.

Another aspect of this invention relates to a method of treating diaper rash in a human comprising applying the composition of this invention to human skin.

The composition of this invention is safe, effective, and can be applied directly to the skin (ie, by spraying). Spraying avoids the need to first put the composition on the hands or an application device and then rub it onto the skin of an infant or other human. Such friction on skin already affected with, for example, diaper rash would probably cause discomfort. The composition of this invention is storage stable, even though it may contain

<img file="ECSP014064A_D0007.tif" />

a significant concentration of solids such as zinc oxide particles. The composition can be sprayed using a portable pump sprayer (a portable pump spray dispenser), ie without the need to use a pressurized device (eg a device containing a propellant). Portable spray pump dispensers are easier to use, are more environmentally friendly and their use avoids having to use a pressure vessel nearby, for this invention tends to have been applied greasy.

Other aspects of the invention will be technically apparent from the description of the invention.

DETAILED DESCRIPTION OF THE INVENTION example, a baby. The composition of to resist displacement after the skin and has a little touch characteristics for the and advantages of this specialists in the

The composition of this invention is a liquid, hydrophobic, substantially anhydrous, pumpable spray composition that is designed to be sprayed onto the skin of an infant or other human to protect the skin (for example, for the treatment of diaper rash ). This composition is believed to be the first skin protective spray composition that is, among other things, liquid, designed for direct application to the skin of a human (including sensitive baby skin), effective for protect the skin to which it is applied, has adequate adhesion to the skin, may contain particles (for example silica), storage, pumpable for diaper rash treatment composition is also believed to be hydrophobic, substantially anhydrous and spray stable and resists displacement, that the liquid realization of the diaper rash spray for treatment spray is designed for the direct application to the skin of a baby, provides effective treatment of diaper rash, has adequate adhesion to the skin, it may contain zinc oxide particles, is storage stable, hydrophobic, substantially anhydrous and pumpable for spraying, and resists creep.

By the term liquid is meant that at 20 degrees Celsius at atmospheric pressure, the substance in question has a continuous liquid phase and otherwise meets the definition of a liquid. For example, the composition of this invention is liquid before being sprayed because it is the first of the diaper, among other things, it is

<img file="ECSP014064A_D0008.tif" />

to that of is a continuous liquid phase at 20 degrees Celsius and atmospheric pressure. Thus, for example, the presence of solid particles (for example, zinc oxide and/or silica) in the composition does not prevent it from being considered a liquid composition.

By hydrophobic is meant that the composition, when on the skin, substantially prevents the passage of liquid water through the composition for a sufficiently long period of time. Thus, for example, in the case of a diaper rash treatment composition of this invention, the composition is hydrophobic in that it prevents the passage of water for at least the typical period of time between diaper changes ( for example three hours, five hours, seven hours or, in some cases, even more).

For substantially contained in approximately approximately approximately approximately approximately approximately approximately add nothing separately when any of the composition may contain small amounts of water, some water is present in the composition of this invention, desirably not free water ( ie not emulsified) and therefore desirably there is no separate aqueous phase. In this manner, preferably, at least as can be seen with the naked eye (i.e., 20/20) without the aid of any magnifying or detecting equipment, no separate aqueous layer is formed when the composition of this invention remains at rest degrees Centigrade. in inert.

anhydrous in 3%p, 2%p, l%p,

0.5%p,

0.3%p, in

5% is understood composition will be weight, typically desirably ] more desirably even more desirably preferably more preferably less less less less &gt; less less less water a a a a a a 0, l%p and even more preferably less than 0.05% p.

water intentionally how the composition is manufactured, i ingredients used for the of of of of of of of of of of

Although preferably no ingredient it is possible to formulate the If a closed container filled with gas for 24 hours at 20

The presence of free water in the composition tends to adversely affect the physical and other properties of the composition. A greater amount of free water could create a discrete water layer and/or increase the surface tension of the composition (reducing the ability of the composition to wet the working parts of the spray pump manifold and therefore to spray easily ) and/or reduce the adhesion of the composition to the skin (viscosity) and/or increase bleeding (i.e., the tendency of the composition to move from the skin to which it has been applied due to gravity or other force). Thus, free (i.e., non-emulsified) water present in a layer of composition on skin being protected (including skin being treated) is believed to reduce the effectiveness of the composition for its intended purpose. skin protection (for example, in the treatment of diaper rash) by reducing the sprayability of the composition, by reducing the barrier properties of the composition (including rendering the composition less hydrophobic) and by facilitating the composition to leave the skin being treated prematurely (for example, to be rubbed off the skin prematurely). or that flows from the skin by the force of gravity) . If the composition were to be formulated with water, it would be necessary to add an emulsifier; however, a feature of this invention is that the composition may be free of an emulsifier. Preferably, the composition is devoid of an emulsifier. Including an emulsifier in the composition (so that there is no free water) would tend to make the composition less spray-pumpable and less hydrophobic, and a feature of this invention is that the composition is spray-pumpable and hydrophobic. .

By pumpable for spraying it is meant that a portable spray pump dispenser can be used to dispense the composition, which is liquid at 20 degrees Celsius at normal atmospheric pressure, by spraying, using normal finger pressure on the equipment portion. spray pump designed to be activated by the pressure of a finger. By "spray" is meant a stream of finely divided liquid composition. (See, for example, US Patent Nos. 3,159,316, 4,034,900, and 4,050,860, which show different spray pump dispensers). The portable spray pump dispenser used to dispense (spray) a composition of this invention typically contains the composition at atmospheric pressure and, only when finger pressure is applied, does the spray pump mechanism temporarily pressurize the composition to 45 causing a portion thereof to leave the dispenser in the form of a spray. In the mechanism, the pressure

4/ -my ufo and VM

<img file="ECSP014064A_D0009.tif" />

it returns to atmospheric pressure shortly after the small portion of composition has been dispensed. Such a portable dispensing pump distributor is considered a non-pressurized distributor. In other words, a feature of this invention is that a portable spray pump dispenser (ie, a non-pressurized dispenser) can be used in the normal way to dispense the composition of this invention.

Spray cans or aerosol cans using propellants (eg FREON or another fluid having a vapor pressure at 20 degrees Celsius significantly greater than atmospheric pressure) are well known types of pressure dispensers. Another type of pressure distributor is one that has a deformable flexible chamber 15 that has been force-filled with enough mass to cause it to expand. The memory of the flexible vesicle material causes it to try to return to its initial, undeformed shape and size, thereby applying pressure to the mass inside the vesicle. 20 Another type of pressure distributor is a motor-driven pump (for example, a centrifugal pump or a positive displacement pump).

The higher pressures than are provided by pressurized dispensers are not needed to dispense (spray) the composition of this invention, although they may be used in some cases. The fact that a pumpable spray composition of this invention may also be dispensed using a pressurized distributor (for example, a distributor containing a propellant, a distributor containing an expanded flexible chamber, or a motor-driven pump) does not mean that the composition is not pumpable for spraying; however, portable pump-spray dispensers (ie, non-pressurized dispensers) are preferred for use in spraying the composition of this invention onto the skin to be treated. Generally speaking, portable spray pump dispensers are less expensive, more economical, and more environmentally friendly than lo? pressure distributors.

No special design is believed to be necessary for the portable spray pump dispenser, although some adjustment of certain dimensions and/or materials of construction may be necessary because of the physical and chemical properties of the particular composition 45 to be dispensed. As will be understood by those skilled in the art, the particular design of the fuel pump manifold

-cbcl^ff and

<img file="ECSP014064A_D0010.tif" />

Spraying is not critical and any portable spray pump dispenser can be used that allows proper dispensing of the composition of this invention, in which the composition is sufficiently stable on storage and is not adversely affected by the composition ( for example, due to prolonged storage). Generally speaking, spray pump dispensers are affected to some extent by the compositions they contain and dispense. For example, storage of the composition in the pump spray manifold in a hot climate for an extended period can cause different parts of the pump spray manifold to swell to different degrees. This in turn can adversely affect the operation of the spray pump and the distribution (spray) of the composition. The selection of a suitable spray pump portable manifold design and materials of construction is well within the skill of the art.

The terms, protect the skin and protect the human skin are synonymous, have been defined above, and include the protection and/or treatment of the skin in connection with various indications involving the skin, including diaper rash; minor burns; cuts; scratches; sunburn; cutting, cracking, fissuring or dryness of the skin or lips; skin irritation; and oozing and/or oozing from the skin due to contact with plants of the genus Rhus 30 poison ivy, poison oak, and/or poison sumac.

Diaper rash has been previously defined as an inflammatory condition of the skin in the diaper area (perineum, buttocks, lower abdomen, and inner thighs) due to one or more of the following 35 factors: moisture, occlusion, friction, continued contact with urine, feces, or both, or mechanical or chemical irritation. Thus, diaper rash is the well-known condition that incontinent infants and elderly people frequently suffer from as a result of the use of diapers or the like (eg, incontinence pads). Diaper rash may also be called diaper rash or incontinence dermatitis.

The term diaper rash treatment has been defined above to include treatment of an existing diaper rash, prevention of a diaper rash,

<img file="ECSP014064A_D0011.tif" />

diaper or both.

A composition that is designed to be sprayed on the skin of a baby or another human being is a sprayable composition that will not harm the skin of any human being, even the delicate (sensitive) skin of a baby, will not be toxic it will not cause irritation, it will not produce unpleasant odors, it will not decompose causing harmful reactions, it will not adversely affect the diaper or any other substrate that may be in contact with the composition, etc. Compositions designed to be sprayed on the skin of an infant or other human include compositions designed to be sprayed on the skin of infants or other humans for any indication for which a skin protectant is used.

A composition that is designed to be sprayed on the skin of an infant or other human to protect the skin is a composition that is designed to be sprayed on the skin of an infant or of another human and is effective in protecting the skin .

A composition that is designed to be sprayed on the skin of an infant or other human to treat diaper rash is a composition that is designed to be sprayed on the skin of an infant or other human and is effective in treating diaper rash.

A composition of this invention which has adequate adhesion to skin, after being applied to the skin will remain adhered to the skin under normal conditions of use for a period of time sufficient to have an effective effect (for example, to treat diaper rash). A layer of composition on the skin can be considered as a set of thin parallel layers, each layer being at least one molecule thick. With a composition having adequate adhesion to the skin, the molecular layer of the composition closest to the skin (the lower molecular layer) will temporarily physically and/or chemically bond to the skin at a molecular level, the lower molecular layer. molecular composition above the lower molecular layer will be physically and/or chemically temporarily attached to that lower molecular layer, and so on. The bonds between the skin and the lower molecular layer and between successive molecular layers cannot be permanent, since it would be difficult to remove the composition from the skin.

If a composition resists displacement, the composition, for example, will not flow easily or quickly.

-44' by the force of gravity from the skin where it has been applied. In any particular case, the ability to resist displacement depends not only on the physical and chemical properties of the composition itself, 5 but also on variables such as the thickness of the layer of composition applied to the skin and the condition (for example, lubricity, cleanliness) of the skin on which the composition was applied. Rheology modifiers, optional film-forming agents and optional volatile carrier ingredients used in the composition help to resist creep.

The ability to resist creep of a composition of this invention was compared to the ability to resist creep of two compositions outside the scope of the invention. All tests were performed at room temperature (approximately 20 degrees Celsius). The preferred zinc oxide-containing composition of this invention (described in detail below) was placed in a dispenser that dispenses as a spray nominally 0.13 ml of composition per pump. The spray nozzle was held approximately 2 inches above a piece of FORMICA plastic sheeting, lying flat on a horizontal work surface, so that the center line of the nozzle dispensing opening was perpendicular to the surface of the laminate, and three pumps of composition (a total of nominally 0.39 milliliters of composition) were dispensed. The resulting circle formed on the laminated surface by the sprayed composition had a diameter of approximately 1.5 inches. The piece of plastic sheeting was rotated to a vertical position so that the plane of the circle was perpendicular to the horizontal work surface, and a line was drawn approximately 4 inches by 12 inches below the bottom edge of the circle and parallel to the top. horizontal work surface. The preferred zinc oxide-containing composition of this invention did not drift from its 1.5-inch circle or cross the line at about 4 inches even after 2 hours.

The test was also performed with two compositions outside the scope of the invention: (1) a liquid consisting only of the mineral oil used in the preferred zinc oxide-containing composition and (2) a liquid consisting of 99% wt. that mineral oil and a l%w of the dimethicone used in the preferred composition containing oxide of (KUidU cif# zinc. The 100%w mineral oil traveled down the surface of the plastic laminate and traveled the distance of approximately 10.2 centimeters in less than one second. The liquid consisting of 99 wt% mineral oil and 1 wt% dimethicone traveled down the surface of the plastic laminate and traveled the distance of approximately 10.2 centimeters in approximately 4 seconds.

As used herein, the term drift resistant means that when a composition is tested in this manner, if it drifts at all, it requires at least about 10 seconds to traverse (travel to) the line at a distance of 10.2 centimeters (in other words resists displacement 15 for at least about 10 seconds), typically, requires at least about 15 seconds to traverse the 4-inch line (resists displacement for at least about 15 seconds), typically requires at least 20 about 20 seconds to traverse the 10-inch line .2 centimeters (resists displacement for at least approximately 20 seconds), desirably requires at least about 30 seconds to traverse the line at a distance of 4 inches (resist displacement for at least about 30 seconds), more desirably requires at least about 45 seconds to traverse the line at a distance of 10.2 centimeters (resists displacement for at least about 30-45 seconds), even more desirably it requires at least about 1 minute to traverse the line located at a distance of 10.2 centimeters (resists displacement for at least about 1 minute), preferably still requires at least about 2 35 minutes to traverse the line located at a distance of

10.2 centimeters (resists displacement for at least approximately 2 minutes), more preferably it requires at least about 5 minutes to cross the line located at a distance of 10.2 centimeters 40 (resists displacement for at least about 5 minutes) / more preferably it requires at least about 10 minutes to cross the line located at a distance 10.2 centimeters (resists displacement for at least about 10 minutes) 45 and, in some cases, requires at least approximately 30 minutes to cross the line located at a distance of (tórtih/ &lt;j ni·

10.2 centimeters (resists displacement for at least approximately 30 minutes).

The most preferred compositions do not cross the line at a distance of 10.2 centimeters even after an hour or more and, therefore, can be said to be sag resistant (sag resistant for at least about an hour).

These tests demonstrate that the preferred zinc oxide-containing composition of this invention resists displacement and that neither of the other two compositions tested resists displacement. The last two compositions are outside the scope of the invention because, for example, neither contains a rheology modifier and neither resists displacement. Testing of the preferred zinc oxide-containing composition also demonstrates that it has adequate adherence to skin.

The composition of this invention has the right rheology to be pumpable for spraying (ie, it has a sufficiently low viscosity under shear conditions), as well as to resist displacement after being applied to the skin (ie, it has a viscosity high enough when not in shear condition) . This is due in part to the fact that one or more rheology modifiers are used to cause the composition's viscosity to generally decrease with increasing shear (ie, the composition may be pseudoplastic or thixotropic). Thus, when the composition that has been at rest (ie, not flowing) in the spray pump manifold begins to move, for example, to a tube within the spray pump manifold, the flow increases. shearing and the viscosity of the composition is reduced. As the composition continues to move, eg, in a narrow passageway toward the small nozzle opening of the spray pump manifold, the shear continues to increase and the viscosity continues to decrease. Shear can reach a maximum and viscosity a minimum as the composition passes through the nozzle opening and leaves the spray pump manifold.

After the composition has been deposited on the skin, the force that is applied to the composition is substantially less than when the composition was being forced to move into the spray pump manifold and through the opening. Therefore,

<img file="ECSP014064A_D0012.tif" />

rfcMffo 7 &gt;lrlt the viscosity of the composition on the skin can return to essentially the same as the viscosity of the composition when it was at rest inside the spray pump dispenser (and can be even higher if the volatile ingredients of the vehicle are evaporated, occurs with the return to a shear more what desirably this invention). This according to the reduction in higher viscosity compositions optional use of one or more film-forming agents helps the composition to resist sliding on the skin. In summary, a rheology modifier is a substance suitable for incorporation into a composition of this invention that helps to impart to the composition the necessary transport properties and that renders said composition, for example, pseudoplastic or thixotropic.

In general terms, the composition of this invention contains at least one active ingredient to protect the skin, at least one rheology modifier and a vehicle. A preferred embodiment of this invention contains at least one active ingredient for treating diaper rash, at least one rheology modifier, and a vehicle. The composition contains various perfumes, conditioners, water resistant agents and hydrophobic agents.

The term zinc, white, cocoa starch, zinc skin-protecting active ingredients and of this invention at least one optional ingredient-forming agent include antimicrobials, preservatives, desirably also film-promoting agents. Colorants, emollients, adhesion, include allantoin, topical oil, glycerin, zinc carbonate, skin protectants known or in the future may be effective in protecting the skin, always satisfactorily alone or in active ingredients to form invention.

The term diaper rash ingredients includes mineral oil, zinc oxide, allantoin, white petrolatum, talc oil and topical starch. The for treatment of mineral oil, dimethicone, calamine oxide, kaolin, petroleum jelly, cod liver petroleum jelly, lanolin, talc, aluminum hydroxide gel, shark liver oil butter, acetate

The term active ingredients for also include other substances that are on the skin,: alone that can be used in combination with others a composition of this active ingredient to treat dimethicone, calamine, kaolin, petroleum jelly, cod liver, lanolin, term active ingredients diaper rash too

<img file="ECSP014064A_D0013.tif" />

<img file="ECSP014064A_D0014.tif" />

it includes other substances that are or may in the future be effective in treating diaper rash, provided they can be used satisfactorily alone or in combination with other active ingredients to form a composition of this invention. Of the active ingredients listed above, dimethicone is preferred and a combination of dimethicone and zinc oxide is more preferred.

The concentration of the one or more skin-protecting active ingredients should be at least about 0.001 wt%, usually at least about 0.01 wt%, desirably at least about 0.1 wt%, and preferably at least about 1 l %p. In some cases, the concentration will be at least about 5%w, at least about 10%w, or even at least about 50%w. The FDA allows claims that dimethicone is present in a composition as an active ingredient for the treatment of diaper rash if its concentration in the composition in question is 1% wt to 30% wt (and as long as the 20 other FDA requirements). The corresponding range for zinc oxide under current FDA regulations is 1%w to 40%w. The corresponding range for mineral oil is 50%w to 100%w.

The limitation of at least about 0.001 wt% of at least one skin-protecting active ingredient is satisfied (a) if any skin-protecting active ingredient is present in a concentration of at least about 0.001 wt% (b ) if two or more skin-protecting active ingredients are present in a total concentration of at least about 0.001 wt%, although none of the active ingredients to protect the skin is individually present in a concentration of at least about 0.001 wt%. Similarly, the limitation at least about 0.1 wt% of at least one diaper rash active ingredient is satisfied (a) if any diaper rash active ingredient is present at a concentration of at least 0.1%w (b) if two or more active ingredients for treating diaper rash are present in a total concentration of at least about 0.1%w, although none of the active ingredients for treating diaper rash are individually present at a concentration of at least about 0.1 wt%. Similarly, the limitation at least about 0.001 wt% of at least one rheology modifier is satisfied (a) if any rheology modifier is present in a concentration of at least 0.001 wt% (b ) if two or more rheology modifiers are present in a total concentration of at least about 0.001 wt%, although none of the rheology modifiers are individually present at a concentration of at least about 0.001 wt%.

Other limitations that specify at least a certain percentage by weight of at least one of a certain type of ingredient are to be understood in the same way (allowing tolerances, of course, for different numerical limits and types of ingredients). For example, the limitation of at least about 0.1 wt% of at least one film-forming agent is satisfied (a) if any film-forming agent is present in a concentration of at least about 0.1% po (b) if two or more film-forming agents are present in a total concentration of at least about 0.1 wt%, although none of the film-forming agents 20 is individually present in a concentration of at least 0.1 wt%.

If dimethicone is used, it will typically be present in the composition in a concentration range of about 0.01% to about 30%w, desirably in the range of about 0.1% to about 10%w, and preferably in the range of about 0.2%w to about 3%w. If zinc oxide is used, it will typically be present in a concentration range from about 0.01% to about 40%w, desirably in a range from about 0.1% to about 20%w, and preferably in a range from about 0.2%w to about 15%w. If mineral oil is used, it will typically be present in the composition in a concentration range of about 10% to about 99%w, desirably in a range of about 50% to about 85%w, and preferably in a range from about 55%p to about 80%p.

The dimethicone used will desirably be a crystalline transparent viscous liquid, free of suspended matter and very low in odor. Any dimethicone can be used. A suitable dimethicone has a viscosity in the range of about 333 to about 368 centistokes when measured using a Size 3 Ubbelhode viscometer at 25 degrees Centigrade and a specific gravity of about 0.96 to about 0.98 ( 25 degrees Celsius/25 degrees Celsius).

The zinc oxide used will desirably be a high purity USP (United States Pharmacopeia) zinc oxide, with a typical particle size of about 0.11 microns, a maximum particle size of about 0.14 microns, a surface area minimum specific surface area (BET) of approximately 8 square meters per gram, a typical specific surface area (BET) of approximately 9 square meters per gram, a bulk density of about 0.80 grams per cubic centimeter, a bulk density of about 0.26 grams per cubic centimeter, and about 99.99% of the particles passing through a 325 mesh sieve. Thus, the zinc oxide used herein will typically have a mean particle size of less than about 1 micron (desirably less than about 0.75 micron, more desirably less than about 0.50 micron, still more desirably less than about 0.75 micron). about 0.25 micrometers, preferably less than about 0.20 microns and more preferably less than about 0.15 microns) and a BET surface area of ​​at least about 5 square meters per gram. The size of the zinc oxide particles (and the size of any other particulate matter present in the composition) should not be so large as to prevent spray pumpability of the composition.

The mineral oil is desirably NF (National Formulary) 30 light mineral oil and is a colorless, odorless and transparent oily liquid. Its viscosity will desirably be in the range of about 7 to about 10 centistokes when measured using a Size 2 Ubbelhode viscometer at 40 degrees Centigrade, with a specific gravity of about 0.83 to about 0.84 (25 degrees Centigrade/25 degrees

Centigrade).

The concentration of the one or more rheology modifiers should be at least about 0.001 wt%, usually at least about 0.01 wt%, desirably at least about 0.1 wt%, and preferably at least about 1 wt%. . In some cases, the concentration will be at least about 5%w, at least about 10%w, or even at least about 20%w.

The term rheology modifier includes waxes and

-SI — cintipnh) and Oo6 association thickeners. The term rheology modifier also includes other substances that are or may in the future be useful as rheology modifiers, provided they can be used satisfactorily alone or in combination with other rheology modifiers to form a composition of this invention. The one or more rheology modifiers help to impart the desired transport properties to the composition, that is, they help make the composition, for example, pseudoplastic or thixotropic, so that it can be pumped for spraying but can also resist displacement after being applied to the skin.

The wax, if used, is desirably a mineral wax.

If a mineral wax is used, the composition will typically be present in a concentration range of about 0.01% to about 20%w, desirably in a range of about 0.1% to about 15%w , and preferably in a range from about 0.2%w to about 6%w. The mineral wax will preferably be a white to yellowish odorless waxy solid, desirably with a melting range of about 65 degrees Centigrade to about 71 degrees Centigrade.

The association thickener, if used, desirably comprises a silica and preferably colloidal silicon dioxide NF (National Formulary). Its particle size cannot be so large as to prevent the composition from being pumpable for spraying.

Desirably, both mineral wax and colloidal silicon dioxide are used. The wax helps provide consistency to the composition, provides internal cohesion (internal adhesion) to the layer of composition on the skin (making it easier to remove from the skin), and provides hydrophobicity, as well as acting as a rheology modifier. Colloidal silicon dioxide acts as a rheology modifier, and if zinc oxide is present in the composition, the silicon dioxide helps to suspend the zinc oxide particles. It is considered that between these two types of rheology modifiers (waxes and association thickeners), the association thickeners play a major role in providing the composition of this invention with the desired transport properties to be, for example , pseudoplastic or thixotropic.

The vehicle can comprise more than one ingredient. The concentration of the vehicle in the composition should be at least about 10%w, usually at least

<img file="ECSP014064A_D0015.tif" />

approximately approximately approximately approximately approximately The, desirably preferably more preferably still preferably at at least less less includes mineral oil and The term vehicle also provided that they can be used in combination with other isostearyl, a a a a 50%py more 60% p.

The term mineral oil substitutes carrier includes other substances that are or may be useful in the future as carriers, satisfactorily alone or carrier ingredients to form a composition of this invention.

Mineral oil substitutes include alkanes having at least 10 carbon atoms (eg, isohéxádécáño), benzoate esters, aliphatic esters, non-comodogenic esters, volatile silicone compounds (eg, cyclomethicone), and volatile silicone substitutes. Examples of benzoate esters include C12-C15 alkyl benzoate, 2-ethyl hexyl benzoate, dipropylene glycol benzoate, octyldodecyl benzoate, stearyl benzoate and behenyl benzoate. Examples of aliphatic esters include C12-C15 alkyl octanoate and dioctyl maleate. Examples of non-comodogenic esters include isononyl isononanoate, isodecyl isononanoate, diisostearyl dilinero diinero, arachidyl propionate and isotridecyl isononanoate. Examples of volatile silicone substitutes include isohexyl decanoate, octyl isononanoate, isononyl octanoate and diethylene glycol dioctanoate.

If mineral oil is used, it will typically be present in the composition in a concentration range from about 10% to about 99%w, desirably in a range from about 50% to about 85%w, and preferably in a range from about 55%p to about 80%p.

If isohexadecane is used, it will typically be present in the composition in a concentration range of about 0.01% to about 50%w, desirably in a range of about 0.1% to about 15%w, and preferably in a range from about 0.2%p to about 10%p. The isohexadecane helps to reduce the greasy feeling of the composition that would be perceived if this component were not present. Isohexadecane itself tends to provide a dry, non-greasy feel.

<img file="ECSP014064A_D0016.tif" />

If cyclomethicone is used, it will typically be present in the composition in a concentration range from about 0.01% to about 99%w, desirably in a range from about 0.1%w to about 20%w, and preferably in a range from about 0.2%w to about 15%w. Cyclomethicone is an evaporative silicone and helps make the composition pumpable for spraying. In addition, after the composition is administered and contacted with the skin, cyclomethicone tends to evaporate, thereby helping the composition to resist displacement and thus fixing the composition on the skin over the skin. that was pulverized

Preferably, the vehicle comprises a combination of mineral oil, isohexadecane and cyclomethicone.

Desirably, at least one film-forming agent is used in the composition. The concentration of one or more

<td colspan="2">training agents</td><td rowspan="2">movie must be 0.001%p, typically</td><td rowspan="2">to the to the</td><td rowspan="2">less less</td>

<td>approximately</td><td>a</td>

<td>20 approximately</td><td>a</td><td>0.01%p, desirably</td><td>to the</td><td>less</td>

<td>approximately</td><td>a</td><td>0.l%p, more desirably</td><td>to the</td><td>less</td>

<td>approximately</td><td>a</td><td>0.2%w, preferably</td><td>to the</td><td>less</td>

<td>approximately</td><td>a</td><td>l%py more preferably</td><td>to the</td><td>less</td>

approximately 2%p. In some cases, the concentration will be at least about 5%w, at least about 10%w, or even at least about 20%w.

The term "film-forming agent" includes polymers such as silicone-containing polymers and synthetic waxes. The term "film-forming agent" also includes other substances that are or may be useful in the future as film-forming agents, provided they can be used satisfactorily alone or in combination with other film-forming agents to form a composition of this invention.

Silicone-containing polymers that are useful herein will typically have silicone-affinity groups and hydrophobic groups. An example of a silicone-containing polymer that can be used as a film-forming agent is a polydimethylsiloxanepolypropylene glycol ether/isopropyldiisocyanate copolymer, which is a silicone polyurethane and is described as a pale yellow, semi-transparent viscous liquid. Such a material is marketed under the name Polyderm PPI-SI-WI 45 by Alzo Inc., located in Matawan, New Jersey, USA. If this silicone-containing polymer is used,

-rt C y (iJrí/ will typically be present in the composition in a concentration range from about 0.01% to about 15%w, desirably in a range from about 0.1% to about 10%w, and 5 preferably in a range from about 0.2%w to about 3%w. This polymer acts not only as a film-forming agent, but also as a conditioner and emollient, helps impart hydrophobicity, and helps give the composition adherence to the skin.

This polymer also helps to couple the silicone-containing components present (eg, dimethicone and cyclomethicone) to the non-silicone-containing components present (eg, mineral oil).

An example of a synthetic wax that can be used as a film-forming agent is described as a highly branched hydrocarbon made from olefins. A suitable synthetic wax may have a polydispersity of about 2.4, a number average molecular weight of about 900, and a weight average molecular weight of about 2,200. One such suitable material is marketed under the name Performa V 825 Polymer by New Phase Technologies, located in Piscataway, New Jersey, USA. The company's NPT Technical Bulletin 6825-1" (revision dated 3/99) describes material 25 as an excellent conditioner and film former that provides gloss to lipsticks and improves the rheology of sunscreen formulations. If this synthetic wax is used, it will typically be present in the composition in a concentration range of about 0.01% to about 30%w, desirably in a range of about 0.1% to about 10%w, and preferably in a range from about 0.2%w to about 6%w. This synthetic wax functions not only as a film-forming agent, but also helps impart hydrophobicity.

Many different optional ingredients may be included in the composition including colorants, perfumes, antimicrobial agents, preservatives, emollients, conditioners, adhesion promoting agents, water resistance agents, and hydrophobic agents. For example, an aloe barbadensis product may be included as well as vitamins such as vitamin E. If an aloe product is used in the composition, it will typically be present in a concentration range of about 0.01% pa to about 15% p, desirably in a range of about 0.1% p a ti&lt;i&lt; 4 *1 ítotv about 10%w, and preferably in a range from about 0.2% to about 6%w. Vitamin E, if used in the composition, will typically be present in a concentration range of about 0.01% to about 5%w, desirably in a range of about 0.1% to about 3%w , and preferably in a range from about 0.2% to about 1% wt, and can be added in the form of its acetate ester.

A preferred composition without zinc oxide and a preferred composition with zinc oxide are shown below (numerical values ​​are in percent by weight).

<img file="ECSP014064A_D0017.tif" />

sfi^h rm

<td>ingredient</td><td>Preferred Composition Without Zinc Oxide</td><td>Preferred Composition With Zinc Oxide</td>

<td>Mineral oil</td><td> 70,95</td><td> 66,50</td>

<td>Polyderm PPI-SI-WI</td><td> 1,00</td><td> 0,50</td>

<td>Dimethicone</td><td> 1,00</td><td> 1,00</td>

<td>mineral wax</td><td> 5,00</td><td> 2,25</td>

<td>Polymer Performa V 825</td><td> 2,00</td><td> 1,30</td>

<td>colloidal silicon dioxide</td><td> 2,30</td><td> 2,10</td>

<td>cyclomethicone</td><td> 9,00</td><td> 8,50</td>

<td>isohexadecane</td><td> 6,50</td><td> 5, 60</td>

<td>Aloe Barbadensis Extract</td><td> 2,00</td><td> 2,00</td>

<td>Vitamin E Acetate</td><td> 0,25</td><td> 0,25</td>

<td>Zinc oxide</td><td> 0,00</td><td> 10,00</td>

<td>Total</td><td> 100,00</td><td> 100,00</td>

A typical procedure for making the preferred zinc oxide composition is described below. The first five ingredients (mineral oil, Polyderm PPI5 SI-WI, dimethicone, mineral wax, and Performa V 825 Polymer) are placed in a suitable stainless steel bowl and heated to approximately 80 degrees Celsius while mixing on low speed. After the mineral wax has melted, the heating is discontinued and the zinc oxide is added while mixing at approximately 500 rpm (revolutions per minute) for at least 10 minutes. When the batch cools to approximately 50 degrees Celsius (while maintaining mixing), the colloidal silicon dioxide is added and the mixing speed is increased to approximately 2,000 RPM, holding this speed for at least 20 minutes. The other ingredients (cyclomethicone, isohexadecane, aloe barbadensis extract and vitamin E acetate) are then added and mixing is continued for approximately 15 minutes. After this period of time, the material is ground to further homogenize it whereby the manufacture is completed. To obtain the preferred composition that does not contain zinc oxide, the procedure is essentially the same, the main difference being that the step in which the zinc oxide is added is omitted. The process for making other compositions of the invention is well within the skill in the art.

<img file="ECSP014064A_D0018.tif" />

When the composition contains suspended solid particles (eg zinc oxide and/or colloidal silica), it would seem more appropriate to refer to the composition as a dispersion or suspension rather than as a liquid. However, although solid particles may be present, the composition of this invention will be referred to as a liquid because (a) the continuous phase of the composition is liquid and will typically make up the majority of the composition (and preferably about 90%w of the composition). itself) and (b) the user is likely to perceive such a composition as a liquid.

For a variety of reasons, such a dispersion or suspension is desirably storage stable, ie the particles desirably do not settle even after a prolonged standing period. When zinc oxide particles are present, silica (eg colloidal silicon dioxide) helps prevent their sedimentation. If the particles settle, they should be quickly and easily redispersible and resuspendable, preferably simply by shaking the composition a few times.

As will be apparent, in a composition of this invention a single ingredient may perform more than one function. Thus, when applying the claims to a given composition, it should be understood that since an ingredient in the composition may perform more than one function, an ingredient may satisfy (or fulfill) more than one limitation of a claim. For example, mineral oil, which can act as an active ingredient, is also a preferred carrier. If mineral oil is present in a composition in at least the minimum concentration for a skin-protecting active ingredient specified by the limitation of a given claim, then the mineral oil in that composition meets the limitation of the claim. If mineral oil is also present in that composition in at least the minimum concentration specified for the vehicle by another limitation of the same claim, then the mineral oil in that composition also meets that limitation of the claim. Thus, the same ingredient and amount of ingredient may satisfy more than a single limitation of a claim. (If no numerical minimum is specified in a limitation of the claim that requires the presence of an ingredient, for example, a limitation that requires only vehicle, that limitation is (or is) satisfied if at least some of the ingredient is present.

<img file="ECSP014064A_D0019.tif" />

<img file="ECSP014064A_D0020.tif" />

ingredient.

Certain variations and modifications will be apparent to those skilled in the art, and the claims are intended to include all modifications and variations within the true spirit and scope of the invention.

<img file="ECSP014064A_D0021.tif" />

<img file="ECSP014064A_D0022.tif" />

J5

<img file="ECSP014064A_D0023.tif" />

Having described the invention as above, what is contained in the following is declared as property