Drug injection device with particular optical window elements for unambiguous legibility of dose value

The present disclosure relates to an arrangement for a drug delivery device, which is a syringe-type device, such as a pen-type syringe. In addition, the present disclosure relates to drug delivery devices.

For example, a drug delivery device is known from Patent Document 1.

<p><patcit num="1"><text>WO2008 / 058665A1</text></patcit></p>

<p> An object of the present disclosure is to make it easier to identify the indicia of a drug delivery device.</p>

<p> This object is achieved by the subject matter of the independent claims. Advantageous embodiments and improvements are set forth in the dependent claims.</p><p> One aspect of the disclosure relates to a device for a drug delivery device, such as a syringe type device. The device for the drug delivery device includes an optical element and an induction member. The indication member includes a plurality of prints. The optics include an imaging section and a non-imaging section. The indication member is movable relative to the optical element so that the print is continuously moved to the display position relative to the optical element.</p><p> In one embodiment, the imaging section is configured to image the first print within the imaging solid angle when the first print is placed at the display position.</p><p> The viewing side of the optical element may be the side of the optical element deviating from the induction member. Therefore, the induction member is arranged on the side opposite to the viewing side of the optical element.</p><p> In one embodiment, the non-imaging section is, for example, light reflected from an indicating member such that the second print cannot be identified by the user within the viewing solid angle of the optical element. , The light defining the second print is configured to be deflected by the non-imaging section. It is convenient for the imaging section to be transparent.</p><p> In one embodiment, the non-imaging section is light transmissive.</p><p> A further aspect of the disclosure relates to a drug delivery device, including a device. The optics are designed to form a dose window for the drug delivery device. A dose window is provided to allow the user to view or inspect the dose print of the drug delivery device provided, for example, on the internal member of the drug delivery device, such as an indication member. The distance between the indicating member and the optical element may range from, for example, about 0.2 mm in the central region of the optical element to 0.3 mm, for example, in the outer edge region of the optical element. The induction member may be a display member of the drug delivery device. The drug delivery device can include a needle or needle assembly in which the drug is dispensed from or through the drug delivery device.</p><p> In one embodiment, the device is configured such that different prints are moved to the display position during the dose setting and / or dose dosing operation of the drug delivery device. Therefore, the indication member can be moved with respect to the optics and vice versa.</p><p> Specifically, the light that defines the print, which is visible light, can mean that the light defines the outline of the print. Therefore, the print itself and the area surrounding the print can reflect light in various ways so that the contour can be seen. As a result, the light is reflected from either the print or the area surrounding the print.</p><p> Preferably, the display position of the print is the position where the dose or dose size of the drug delivery device corresponding to this print is set, where the user clearly identifies the print within the imaging solid angle by an optical element. can do.</p><p> The imaging solid angle is a solid angle at which the print placed at the display position is clearly identified by the user. Therefore, the image produced by the imaging section is defined or limited in scope by the imaging solid angle. Here, the imaging solid angle extends above the image. The image is associated with the first print when the first print is placed in the display position.</p><p> From a manufacturing point of view, it is advisable to form the housing and dose window of the drug delivery device from a single component. This means that the housing is transparent and requires an opaque covering. For this purpose, when printing or labeling the housing, a gap is usually left around the dose window. When a volume is set by the drug delivery device and the print corresponding to this dose is shown through the dose window, marks, letters or other prints that are not placed in the display position may be visible through this gap. This can confuse the user when setting the dose. If the dose window is configured as a magnifying lens, the markings or prints may appear misaligned, which can be very confusing to the user.</p><p> According to the present disclosure, when the first print is placed in the display position, the first print is visible to the user, but the second print placed close to the first print can be identified by the user. Nothing is achieved. In this way, the first print or the second print placed in close proximity to any other mark cannot be identified by the user within the viewing solid angle of the optical element and is therefore used. Prevent confusion.</p><p> In one embodiment, the print comprises numbers and / or non-numeric characters such as dose numbers. Non-numeric characters preferably separate adjacent numbers. Non-numeric characters can include symbols such as dashes.</p><p> Preferably, the first print includes the dose number and the second print, which may be near the first print, includes a dash that separates the first print from the other prints. Alternatively, both the first and second prints can indicate a dose number indicating the size of the drug to be administered from the drug delivery device in sequence of the set dose or dose of the drug to be administered. The sizes that follow in sequence may differ from each other by, for example, 2 units, 4 units, or 1 unit. The unit is associated with the minimum amount of drug set to be dosed by the drug delivery device. The print may be printed, for example, on the outer surface of the indication member.</p><p> In one embodiment, the non-imaging section surrounds the imaging section, especially in plan view from the viewing side. The non-imaging section can define the boundary region of the optical element. Advantageously, if the first print is placed in the display position, the first print is projected by the imaging section regardless of the mutual placement of the first print and the second print, while It is easily achieved that the second print cannot be identified by the user within the viewing solid angle of the optical element.</p><p> In one embodiment, the optical element is included in the body. The device includes a covering that defines the window. The windows are arranged so that the optical elements can be seen through the windows. Preferably, the covering covers an area of the body other than the area where the optics are located. Apart from the optics, the body may be opaque, translucent, partially opaque or partially translucent. Alternatively, the body may be transparent. Preferably, the body is transparent.</p><p> In one preferred embodiment, the covering is opaque. In particular, when the body is embodied as transparent, it is a good idea that the covering can define the window. Thus, it is achieved that the user can see through the window or, in some cases, the optics, while structures not covered by the window are invisible or hidden by the user. Advantageously, the user's attention is focused on a structure or element, such as a print, that can be seen, for example, from outside the drug delivery device through a window and / or optics.</p><p> In the present disclosure, "transparency" can relate to structural properties through which an object can be viewed or analyzed, including its contours. "Translucent" can relate to structural properties that are partially light transmissive, such that the contours of an object cannot be seen or analyzed.</p><p> The body can constitute the outer housing of the drug delivery device. It is preferred that the user cannot identify any features of the drug delivery device that are not covered by the window.</p><p> In one embodiment, the imaging section extends above the first print when the first print is placed in the display position.</p><p> In one embodiment, the non-imaging section extends at least partially over the second print when the first print is placed in the display position. In other words, the projection of the imaging section above the injection member extends above the first print when the first print is placed in the display position, and the projection of the non-imaging section is the first. At least partially extends over the second print when the print is placed in the display position. Therefore, the projection of the optics on the injection member is on top of the first print, and even on a second print or part of any other print that is placed close to the first print. Extend.</p><p> In one embodiment, the imaging section is raised compared to the non-imaging section. Advantageously, this embodiment enables the embodiment of the imaging section according to the specific imaging requirements of the imaging section. For example, the bulge of the imaging section facilitates the realization of the imaging section as or according to the magnifying element. In addition, the side walls of the imaging section formed by the ridges can reflect the light that defines the second print. Therefore, the ridge facilitates the light being deflected so that the user cannot identify the light within the imaging solid angle.</p><p> In one embodiment, the imaging section is formed according to a magnifying element such as a lens. The advantage of this embodiment is that the readability of the print is improved, especially for people with poor eyesight, such as the elderly. In addition, the embodiments are also advantageous for diabetics who often suffer from diminished visual acuity.</p><p> When the imaging section is embodied as a magnifying element, the user can see the magnified first print within the viewing solid angle when the first print is in the display position.</p><p> In one embodiment, the non-imaging section is a transparent refracting section that includes an interface. The boundary surface is arranged so that when the first print is placed at the display position, the second print cannot be identified by the user within the viewing solid angle of the optical element.</p><p> In one embodiment, the interface comprises a flat or flat portion oriented at an angle to the optical axis of the device.</p><p> In the present disclosure, "oblique" or "oblique" preferably means that one component is not positioned or oriented perpendicular to another component.</p><p> The optical axis may be the axis on which the optics and the first print are aligned when the first print is placed in the display position.</p><p> Due to the oblique orientation of the interface of the non-imaging section, the light emitted or reflected from the indicating member and passed through the optics is refracted in the non-imaging section differently than in the imaging section, thereby providing a second The light that has defined the print and passed through the non-imaging section will be refracted to the region outside the viewing solid angle. In one embodiment, the interface is the first print that is projected by the structured plane outside the viewing solid angle of the optical element when the first print is placed at the display position. The second print is located outside the imaging solid angle and is within the second solid angle on the viewing side, which is different from the first solid angle, including a structured surface configured to have a solid angle. Cannot be identified.</p><p> Preferably, the non-imaging section is configured such that the interface surrounds the imaging section. A structured surface can include multiple planes or flat parts, the surface normals of which are tilted relative to each other and / or with respect to the optical axis. On the viewing side of the optics, the surface normals of one or more of those parts are preferably oriented away from the optical axis so that the first print is placed in the display position. While the light is emitted or reflected from the indicating member, the light defining the second print is deflected by the interface, so the second print is the user within the viewing solid angle of the optical element. Will not be able to identify. In other words, the interface can deflect the light that defines the second print out of the viewing solid angle. Therefore, only the first print can be identified by the user within the imaging solid angle.</p><p> The flat portion may be suitable for projecting a second print, for example, when the first print, which is located close to the second print, is in the display position. Advantageously, the user is confused by the second print, as well as other prints or markings, even when reading or inspecting the set dose or set dose size of the drug delivery device within the solid angle outside the viewing solid angle. I can't let you.</p><p> In one embodiment, the non-imaging section is a translucent diffusion section. According to this embodiment, advantageously, when the first print is placed in the display position, the first print is projected by the imaging section within the imaging solid angle and the second print is not projected and is non-imaging. It is achieved that it becomes indistinguishable to the user as it is spread by the sections. The translucent diffuse section can include a rough surface that prevents the second print from being projected when the first print is placed in the display position. The rough surface can include a surface texture containing features having dimensions of, for example, 1 micrometer to 1 millimeter, thereby allowing light emitted or reflected from the indication member and passed through a non-imaging section. Will be diffused.</p><p> In one embodiment, non-imaging sections are provided along both sides of the optics. Both sides can face the proximal and / or distal end of the device. This is especially proximal to the device for the first printing when, for example, a dash separating the two dose numbers is placed correspondingly on the injection member, i.e. the first print is placed in the display position. It is a good idea if it is placed on the side facing the end and / or the distal end. The non-imaging section is not needed on the other side of the optics, the corresponding side of the first print of the indication member, which would not be printed there if it could be projected within the imaging solid angle. You may.</p><p> The longitudinal axis of the device can extend from the distal end to the proximal end of the device. The longitudinal axis of the device may coincide with the longitudinal axis of the drug delivery device. The distal end of the device may be the distal end or towards the distal end of the drug delivery device, and the proximal end of the device is the proximal end or towards the proximal end of the drug delivery device. May be suitable for.</p><p> The distal end of the drug delivery device can indicate the end where the drug is administered from the drug delivery device and / or the needle is placed there.</p><p> The proximal end of the drug delivery device can indicate the end that is located farthest from where the drug is administered from the drug delivery device and / or farthest from the needle.</p><p> The features described above and below in conjunction with various aspects or embodiments herein can also be applied to other aspects and embodiments. Further features and advantages of the subject matter of the present disclosure will become apparent from the description of the exemplary embodiments below, along with the drawings.</p>

<figref num="1">It is a schematic diagram of a drug delivery device.</figref><figref num="2">It is a schematic partial sectional view of an apparatus.</figref><figref num="3">FIG. 5 is a diagram of an exemplary embodiment of dose printing.</figref><figref num="4">FIG. 6 is a schematic partial cross-sectional view of an apparatus according to an exemplary embodiment.</figref><figref num="5">FIG. 3 is a partial perspective view of the device according to a further exemplary embodiment.</figref><figref num="6">FIG. 5 is a schematic cross-sectional view of the apparatus according to the embodiment shown in FIG.</figref>

In drawings, similar elements, elements of the same type and elements having the same function may have the same reference number. Moreover, the scales in the drawings may not be accurate. Rather, certain features may be exaggerated to better demonstrate important principles.

FIG. 1 is a schematic view of the drug delivery device 200. The drug delivery device 200 may be a syringe-type device, such as a pen-type syringe. The device can be operated by the user to set and administer a fixed dose of the drug, or preferably a variable dose of the drug, which is a user-configurable dose size. The drug delivery device 200 includes a body 6 and a covering 19 (see FIG. 2) that defines the window 8. The covering 19 is opaque. It is preferable that the user can see the actually set dose through the window 8. The main body 6 further includes an optical element 1 having a rectangular shape in a plan view. The optical element 1 is designed to form a dose window for the drug delivery device 200 that displays dose information to the user, such as a set dose size. The optical element 1 is visible in the window 8. The covering 19 can cover a region other than the region where the optical element 1 of the main body 6 is located. The optical element 1 includes an imaging section 4 and a non-imaging section 5. Imaging section 4 is preferably transparent to visible light. The non-imaging section 5 is preferably transparent to visible light. The non-imaging section 5 surrounds the imaging section 4. The optical element 1 is framed by the window 8. Thereby, it is preferable that the device is fixed to the main body 6. The drug delivery device 200 further includes an indication member 2 with a plurality of prints, specifically a dose number 3. The indication member 2 arranged in the main body 6 can form a display member of the drug delivery device. In the state described, the dose number 3 is arranged at the display position with respect to the optical element 1. In this state, the dose number 3 is projected within the imaging solid angle 9 by the imaging section 4. The imaging solid angle 9 indicates a solid angle at which the user of the drug delivery device 200 can easily and clearly inspect or view the print 3 from the viewing side of the optical element 1. Viewing side of optical element 1 (see 13 in Fig. 2) ) Is the side of the optical element 1 deviated from the induction member 2. The viewing side 13 is outside the drug delivery device 200.

The print 3 can indicate, for example, the set dose size of the drug delivery device 200, which is the number of the set unit of the drug to be administered. Indication member 2 includes a dose number 3 so that during the dose setting and / or dose dosing operation of the drug delivery device 200, the dose number close to the drawn dose number 3 is moved to the indicated position. It is movable with respect to the optical element 1. The above-mentioned movement is an axial or spiral movement of the optical element 1 or a rotation of the drug delivery device 200 about the longitudinal axis x. Therefore, the dose numbers are arranged axially, spirally or angularly around the outer circumference of the indication member 2 (see FIG. 3). The longitudinal axis of the drug delivery device 200 can extend between the distal and proximal ends of the drug delivery device 200.

FIG. 2 is a schematic cross-sectional view of the device 100 including the optical element 1. The drug delivery device 200 can include the device 100. The optical element 1 includes an imaging section 4 and a non-imaging section 5. From the cross-sectional view of FIG. 2, the imaging section 4 appears to be located between the two parts of the non-imaging section 5. The longitudinal axis x of the drug delivery device 200 may coincide with the longitudinal axis of the device 100. In this embodiment, the induction member 2 includes, but is not limited to, a plurality of prints represented by a first dose number 3a and a second dose number 3b, 3c. Further printing is represented herein by a dash 7, which is placed in close proximity to dose numbers 3a, 3b and 3c. The direction in which the dose numbers 3a, 3b and 3c are aligned (horizontally) along them may be parallel to the longitudinal axis x. The dose number 3a, which can represent the first print, points towards the imaging section 4 of the optical element 1. In the state shown in FIG. 2, the first print 3a is arranged at the display position with respect to the optical element 1 and can therefore be identified by the user within the imaging solid angle 9. The optical axis 11 is shown in FIG. 2 and can pass through the center of imaging section 4. The optical axis 11 can further travel radially with respect to the longitudinal axis x. The projection of imaging section 4 or imaging section 4 on the injection member 2 extends along dose number 3a. Optical element 1 extends along dose numbers 3a and dash 7, and further extends partially along dose numbers 3b and 3c. The distance between the induction member 2 and the optical element 1 may be in the range of about 0.2 mm to 0.3 mm.

The diagonal dashed lines on both sides of the device 100 in FIG. 2 indicate the imaging solid angle 9. The imaging section 4 of the optical element 1 is raised as compared to the non-imaging section 5. The advantage of this ridge is that the imaging section 4 is composed of, for example, a magnifying lens, as indicated by the curved surface of the imaging section 4. Therefore, the dose number 3a is extended to the user when the user reads or identifies the dose number 3a.

The imaging section 4 is configured such that the dose number 3a is projected by the imaging section 4 within the imaging solid angle 9. Non-imaging section 5 allows the user to identify dose numbers 3b, 3c and / or dash 7 or elements on the indication member that are not in the display position within the imaging solid angle 9 of viewing side 13 of optical element 1. The light defining the element is configured to be deflected by the non-imaging section 5 so that it cannot be done. In device 100, the indication member 2 is moved such that the dose number 3a is moved out of the display position when the dose size of the drug indicated by the dose number 3a and projected by the imaging section 4 is changed by the user. It is configured as follows. As a result, one of the dose numbers 3b and 3c is moved to the indicated position. Therefore, this print will then be projected within the imaging solid angle 9 by the imaging section.

FIG. 3 is a simplified partial top view of the Indication Member 2 including an exemplary dose number 3 and a dash 7. The dose number 3 and the dash 7 separating the print 3 are aligned along an axis parallel to the longitudinal axis x, respectively. Print 3 is arranged in a spiral, so two consecutive prints in the vertical or circumferential direction show the difference between the two dose units. Figure 3 outlines only a small portion of the possible prints.

FIG. 4 is a schematic partial cross-sectional view of the device 100 in which the dose number 3a is in the display position corresponding to the state shown in FIG. Imaging section 4 is also raised compared to non-imaging section 5. The imaging section 4 is preferably formed by a magnifying lens. The side wall 26 of the imaging section lies between the imaging section 4 and the non-imaging section 5. The side wall 26 connects the imaging section 4 and the non-imaging section 5. The side wall 26 is defined by the extent to which the imaging section 4 is raised above the non-imaging section 5. The dose number 3a is projected within the imaging solid angle 9 by the imaging section 4, as indicated by the optical path 19, so that the user can view the dose number 3a within the imaging solid angle 9 on the viewing side 13 of the optical element 1. Can be identified. In this embodiment, the non-imaging section 5 is preferably transparent to visible light and includes an interface 10. The boundary surface 10 is oriented obliquely with respect to the optical axis 11. The interface 10 may be partially flat, or if the optics 1 are rectangular, for example each optic 1 may include a plane or a portion 16. The portion 16 may be flat and can define a surface normal 14 tilted with respect to the optical axis 11. Due to the tilt of the interface 10, the light defining the dose numbers 3b and 3c is deflected out of the imaging solid angle 9, so the user identifies the dose number within the imaging solid angle 9. You will not be able to. Although not explicitly shown, the cross section of the portion does not have to be flat. FIG. 4 shows exemplary optical paths 20a and 20b of light extending from the induction member 2 defining a dose number 3c. Light from the optical path 20a passes through non-imaging section 5. The light is deflected towards the region outside the viewing solid angle 9 by the non-imaging section 5, which makes dose number 3c indistinguishable within the viewing solid angle 9. Therefore, the light is on the side wall 2 It is refracted at 6 and then reflected longitudinally, thereby deflecting it away from the optical axis 11. Further, or otherwise, the light traveling along the optical path 20b can re-enter the imaging section of the optical element 1 after passing through the non-imaging section 5. The light is then reflected so that it is completely reflected, for example, at the surface 27 of the imaging section 4, whereby the optical element 1 does not remain within the imaging solid angle 9.

On the other hand, the light from the viewing side 13 by the optical path 21 is refracted in the non-imaging section 5 and passes through it. The light is then re-biased as it exits non-imaging section 5 and therefore does not hit doses 3b and 3c. In other words, the light is deflected by the non-imaging section 5 due to the tilting of the interface 10, which allows the optics 1 to partially extend over doses 3b and 3c, but at doses. Only 3a will be viewed by the user. The index of refraction of non-imaging section 5 is adjusted accordingly. Due to the tilt of the interface 10 of the non-imaging section 5 of the optical element 1, the dose numbers 3b and 3c are not discernible to the user within the imaging solid angle 9 of the viewing side 13 of the optical element 1. Use at least a small dose of 3b and 3c outside the imaging solid angle 9 of viewing side 13 of optics 1 because the light defining the second print is correspondingly deflected by the interface 10. Can be identified. Although not explicitly shown, the optics may be configured such that the non-imaging section extends along only a portion of the outer circumference of the optics. For example, the non-imaging section can extend only along the side of the optic that faces the proximal and / or distal end of the device (see Figure 5). On the other side of the optics, the corresponding side of the first print of the indication member, there would be no second print if it could be projected within the imaging solid angle, the non-imaging section It may not be necessary. In Figure 4, the dashes 7 that separate the dose numbers are omitted. However, dose numbers 3b and 3c may be embodied as dashes. Nevertheless, it is advantageous for the non-imaging section 5 to extend around the entire circumference of the imaging section 4.

FIG. 5 is a partial perspective view of the device 100 according to a further exemplary embodiment. As described in connection with FIG. 4, the optical element 1 including the imaging section 4 and the non-imaging section 5 is preferably transparent to visible light. FIG. 5 shows a non-imaging section 5 of the optical element 1 extending only along the side 18 facing the proximal and / or distal end of the device 100. Therefore, the prints (not shown) are also arranged along the longitudinal axis x in this embodiment. Although not explicitly shown, the optical element 1 may also be configured such that the non-imaging section 5 surrounds the imaging section 4. The non-imaging section 5 can include an interface 10 that includes a plurality of portions 16. Each portion 16 may be flat or flat. The portion 16 can form a structured surface 17 of the boundary surface 10. In this case, the surface normals of portion 16 are tilted with respect to the optical axis 11 and / or with respect to each other. Although not explicitly shown, portion 16 may be uneven, i.e. curved. Preferably, the portion 16 is configured such that the light emitted or reflected from the induction member 2 and passed through the non-imaging section 5 is deflected in a direction across the longitudinal axis x. Part 17 preferably projects the second print when the first print is in the display position, for example, within the first solid angle (see 24 in FIG. 6) outside the viewing solid angle 9. The advantage of this embodiment is that there is a second solid angle (see 25 in FIG. 6) outside the imaging solid angle 9, from which the user cannot identify the second print, so for example a setting. Users will not be confused during dose size testing.

FIG. 6 is a schematic cross-sectional view of the apparatus 100 of the embodiment shown in FIG. 5, where the dose number 3a is located at the display position. A curved device 100 is shown. This curvature is defined by the curvature of the drug delivery device 200. FIG. 6 shows a cross section of the non-imaging section 5 from FIG. Non-imaging section 5 contains three equilateral cuts that define part 16 (see part 16 in FIG. 5). The non-imaging section 5 is formed by the portion 16, so when the light emitted or reflected from the indication member 2 passes through the non-imaging section 5, the user can represent the second print, respectively. It becomes impossible to identify 3b, 3c and 3d. The dose number is preferably placed in close proximity to the dose number 3a (not shown) representing the first print. Compared to the embodiments shown in FIGS. 2 and 4, the dose numbers 3b, 3c and 3d are aligned along the outer circumference of the indication member 2 rather than in the longitudinal direction. The drawings show exemplary optical paths 22 and 23 showing that the light emitted or reflected from the indication member 2 is deflected out of the viewing solid angle 9 by the portion 16. Therefore, the light from the optical path 22 undergoes reflection, such as total internal reflection, and exits the non-imaging section 5. On the other hand, the light from the optical path 23 is simply refracted in the non-imaging section 5.

In the region of the indication member 2 where the dose numbers 3b, 3c and 3d are located, the light is deflected away from the region by the portion 16 of the non-imaging section 5 so that the non-imaging section from the viewing side 13 The light that has passed 5 will not hit. These areas are roughly defined by dashed lines 28 next to prints 3b, 3c and 3d. The index of refraction of non-imaging section 5 is adjusted accordingly. Due to the structure of the structured surface 17, the dose numbers 3b, 3c and 3d cannot be identified by the user within the imaging solid angle 9 of the viewing side 13 of the optical element 1.

In a further exemplary embodiment, the non-imaging section (see Figure 2) is a translucent diffusion section. For this purpose, the non-imaging section can include a rough surface, thereby projecting a print that is placed close to the first print when the first print is placed in the display position. It disappears. The rough surface can include a surface texture containing features having dimensions of, for example, 1 micrometer to 1 millimeter, thereby allowing light emitted or reflected from the indication member and passed through a non-imaging section. Will be diffused.

As used herein, the term "drug" preferably means a pharmaceutical formulation comprising at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound is up to 1500 Da. And / or a mixture of peptides, proteins, polysaccharides, vaccines, DNA, RNA, enzymes, antibodies or fragments thereof, hormones or oligonucleotides, or the pharmaceutically active compounds described above. Here, in a further embodiment, the pharmaceutically active compound is diabetes, or diabetes-related complications such as diabetic retinopathy, thromboembolism such as deep vein thromboembolism or pulmonary thromboembolism, acute coronary syndrome. (ACS), angina, myocardial infarction, cancer, luteal degeneration, inflammation, hay fever, atherosclerosis and / or useful for the treatment and / or prevention of rheumatoid arthritis, where further embodiments In, a pharmaceutically active compound comprises at least one peptide for the treatment and / or prevention of diabetic or diabetic-related complications such as diabetic retinopathy. Here, in a further embodiment, the pharmaceutically active compound is at least one human insulin or a human insulin analog or derivative, a glucagon-like peptide (GLP-1) or an analog or derivative thereof, or exendin-3 or exendin. -4 or exendin -3 or an analog or derivative of exendin-4.

Insulin analogs include, for example, Gly (A21), Arg (B31), Arg (B32) human insulin; Lys (B3), Glu (B29) human insulin; Lys (B28), Pro (B29) human insulin; Asp ( B28) Human insulin; Prolin at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and Lys may be replaced by Pro at position B29; Ala (B26) human insulin; Des (B28-B30) human insulin; Des (B27) human insulin, and Des (B30) human insulin.

Insulin derivatives include, for example, B29-N-myristoyl-des (B30) human insulin; B29-N-palmitoyl-des (B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28- N-Millitoyl LysB28ProB29 Human Insulin; B28-N-Palmitoil-LysB28ProB29 Human Insulin; B30-N-Millitoyl-ThrB29LysB30 Human Insulin; B30-N-Palmitoil-ThrB29LysB30 Human Insulin; -des (B30) Human Insulin; B29-N-(N-Lithocholyl-γ-Glutamil)-des (B30) Human Insulin; B29-N-(ω-carboxyheptadecanoyl)-des (B30) Human Insulin, and B29-N- (ω-carboxyheptadecanoyl) is human insulin.

Exendin-4, for example, H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu -Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2 sequence peptide Exendin-4 (1-39) ) Means.

Exendin-4 derivatives are, for example, the compounds listed below: H- (Lys) 4-desPro36, desPro37 Exendin-4 (1-39) -NH2, H- (Lys) 5-desPro36, desPro37 Exendin-4 (1-39) -NH2, desPro36 Exendin-4 (1-39) ), DesPro36 [Asp28] Oxygen-4 (1-39), desPro36 [IsoAsp28] Oxygen-4 (1-39), desPro36 [Met (O) 14, Asp28] Oxygen-4 (1-39), desPro36 [Met (O) 14, IsoAsp28] Exendin- (1-39), desPro36 [Trp (O2) 25, Asp28] Exendin-4 (1-39), desPro36 [Trp (O2) 25, IsoAsp28] Exendin-4 (1-) 39), desPro36 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39), desPro36 [Met (O) 14Trp (O2) 25, IsoAsp28] Exendin-4 (1-39) ; Or desPro36 [Asp28] oxygen-4 (1-39), desPro36 [IsoAsp28] Exendin-4 (1-39), desPro36 [Met (O) 14, Asp28] Exendin-4 (1-39), desPro36 [Met (O) 14, IsoAsp28] Exendin-(1-39), desPro36 [Trp (O2) 25, Asp28] Exendin-4 (1-39), desPro36 [Trp (O2) 25, IsoAsp28] Exendin-4 (1-39), desPro36 [Met (O) 14, Trp (O2)) 25, Asp28] Exendin-4 (1-39), desPro36 [Met (O) 14, Trp (O2) 25, IsoAsp28] Exendin-4 (1-39), (Here, the group-Lys6-NH2 is exendin. It may be bound to the C-terminus of the -4 derivative);

Alternatively, an exendin-4 derivative having the following sequence: desPro36 Exendin-4 (1-39) -Lys6-NH2 (AVE0010), H- (Lys) 6-desPro36 [Asp28] Exendin-4 (1-39) -Lys6-NH2, desAsp28Pro36, Pro37, Pro38 Exendin-4 ( 1-39) -NH2, H- (Lys) 6-desPro36, Pro38 [Asp28] Exendin-4 (1-39) -NH2, H-Asn- (Glu) 5desPro36, Pro37, Pro38 [Asp28] Exendin-4 ( 1-39)-NH2, desPro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39)-(Lys) 6-NH2, H- (Lys) 6-desPro36, Pro37, Pro38 [Asp28] Exendin-4 (1-9)- 1-39)-(Lys) 6-NH2, H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39)-(Lys) 6-NH2, H- (Lys) 6-desPro36 [Trp (O2) 25, Asp28] Exendin-4 (1-39)-Lys6-NH2, H-desAsp28Pro36, Pro37, Pro38 [Trp (O2) 25] Exendin-4 (1-39) -NH2, H- (Lys) 6-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 ( 1-39) -NH2, H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39) -NH2, desPro36, Pro37, Pro38 [Trp (O2) ) 25, Asp28] Exendin-4 (1-39)-(Lys) 6-NH2, H- (Lys) 6-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39) -(Lys) 6-NH2, H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39)-(Lys) 6-NH2, H-( Lys) 6-desPro36 [Met (O) 14, Asp28] Exendin-4 (1-39) -Lys6-NH2, desMet (O) 14, Asp28 Pro36, Pro37, Pro38 Exendin-4 (1-39) -NH2, H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39) )-NH2, H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39) -NH2; desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39)-(Lys) 6-NH2, H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] ] Oxygen-4 (1-39)-(Lys) 6-NH2, H-Asn- (Glu) 5desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Oxygen-4 (1-39)-(Lys) 6-NH2, H-Lys6-desPro36 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39) -Lys6-NH2, H-desAsp28, Pro36, Pro37, Pro38 [Met (O) ) 14, Trp (O2) 25] Exendin-4 (1-39) -NH2, H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39)- NH2, H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39) -NH2, desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39)-(Lys) 6-NH2, H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (S1-39)-(Lys) 6-NH2, H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39)-(Lys) 6-NH2; or selected from pharmaceutically acceptable salts or solvates of any one of the exendin-4 derivatives described above. To.

Hormones include, for example, gonadotropins (follitropin, lutropin, corion gonadotropin, menotropin), somatropin (somatropin), desmopresin, telluripresin, gonadorelin, triptolerin, leuprorelin, bucererin, nafarelin, gocerelin, etc., Rote Liste, 2008 Pituitary hormones or hypothalamic hormones or regulatory active peptides listed in and their antagonists.

Examples of the polysaccharide include glucosaminoglycan, hyaluronic acid, heparin, low molecular weight heparin, or ultra low molecular weight heparin, or derivatives thereof, or sulfated forms of the above-mentioned polysaccharides, for example, polysulfated forms, and / Or there are those salts that are pharmaceutically acceptable. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.

Antibodies are globular plasma proteins (about 150 kDa), also known as immunoglobulins that share a basic structure. These are glycoproteins because they have sugar chains added to amino acid residues. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit), and secretory antibodies are also dimers with two Ig units, such as IgA, in hard bone fish. It is also a tetramer with 4 Ig units, such as IgM, or a pentamer with 5 Ig units, such as mammalian IgM.

An Ig monomer is a "Y" -shaped molecule composed of four polypeptide chains, two identical heavy chains and two identical light chains linked by disulfide bonds between cysteine residues. Is. Each heavy chain is about 440 amino acids long and each light chain is about 220 amino acids long. The heavy and light chains each contain an intrachain disulfide bond that stabilizes these folded structures. Each strand is composed of a structural domain called the Ig domain. These domains contain approximately 70-110 amino acids and fall into different categories (eg, variable or V, and stationary or C) based on their size and function. They have a characteristic immunoglobulin folding structure that creates a "sandwich" shape in which the two β-sheets are held together by the interaction between the conserved cysteine and other charged amino acids.

There are five types of mammalian Ig heavy chains represented by α, δ, ε, γ and μ. The type of heavy chain present defines the antibody isotype, and these chains are found in IgA, IgD, IgE, IgG and IgM antibodies, respectively.

Different heavy chains differ in size and composition, α and γ contain about 450 amino acids, δ contains about 500 amino acids, and μ and ε have about 550 amino acids. Each heavy chain has two regions, the constant regions (C)._H) And variable region (V)_H). In one species, the constant region is essentially the same for all antibodies of the same isotype, but different for antibodies of different isotypes. Heavy chains γ, α, and δ have a constant region composed of three tandem Ig domains and a hinge region for adding flexibility, and heavy chains μ and ε have four immunoglobulins. -Has a constant region composed of domains. The variable region of the heavy chain is different for antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is approximately 110 amino acids long and consists of a single Ig domain.

In mammals, there are two types of immunoglobulin light chains, represented by λ and κ. The light chain has two contiguous domains, one constant domain (CL) and one variable domain (VL). The approximate length of the light chain is 211-217 amino acids. Each antibody always has two light chains that are identical, and for each mammalian antibody there is only one type of light chain κ or λ.

Although the general structure of all antibodies is very similar, the unique properties of a given antibody are determined by the variable (V) region, as detailed above. More specifically, three variable loops on each light chain (VL) and three on the heavy chain (HV) are involved in antigen binding, i.e. its antigen specificity. These loops are called complementarity determining regions (CDRs). Since CDRs from both the VH and VL domains contribute to the antigen binding site, it is the combination of heavy and light chains that determines the final antigen specificity, not either alone.

An "antibody fragment" comprises at least one antigen binding fragment as defined above and exhibits essentially the same function and specificity as the complete antibody from which the fragment is derived. Limited protein digestion with papain cleaves the Ig prototype into three fragments. Two identical amino-terminal fragments, each containing one complete L chain and about half the H chain, are antigen-binding fragments (Fabs). The third fragment, which is comparable in size but contains a carboxyl terminus at half of both heavy chains with interchain disulfide bonds, is a crystallizable fragment (Fc). Fc includes carbohydrates, complementary binding sites, and FcR binding sites. Limited pepsin digestion results in a single F (ab') 2 fragment containing both the Fab fragment and the hinge region containing the HH interchain disulfide bond. F (ab') 2 is divalent for antigen binding. The disulfide bond of F (ab') 2 can be cleaved to obtain Fab'. In addition, the variable regions of the heavy and light chains can be condensed to form a single chain variable fragment (scFv).

Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. Acid addition salts include, for example, HCl or HBr salts. The basic salt is, for example, an alkali or alkaline earth, for example, a cation selected from Na +, K +, or Ca2 +, or an ammonium ion N + (R1) (R2) (R3) (R4) (in the formula, R1). ~ R4 are independent of each other: hydrogen, optionally substituted C1 to C6 alkyl groups, optionally substituted C2 to C6 alkenyl groups, optionally substituted C6 to C10 aryl groups, or optionally substituted C6 ~ A salt having a C10 heteroaryl group). Further examples of pharmaceutically acceptable salts can be found in Remington's Pharmaceutical Sciences, 17th Edition, Alfonso R. Gennaro (eds.), Mark Publishing Company, Easton, Pa., USA, 1985 and Encyclopedia of Pharmaceutical Technology. ..

A pharmaceutically acceptable solvate is, for example, a hydrate.

The scope of protection is not limited to the examples given above herein. The present invention is embodied in each novel property and each combination of properties, even if this feature or a combination of these features is not explicitly stated in the claims or in the examples. Specifically includes all combinations of any of the features described in the scope.

1 Optical element 2 Indication member 3a Dosage number 3b Dosage number 3c Dosage number 3d Dosage number 4 Imaging section 5 Non-imaging section 6 Body 7 Dash 8 Window 9 Imaging stereoscopic angle 10 Boundary surface 11 Optical axis 13 Viewing side 14 plane normal 15 Optical path (imaging section) 16 parts 17 Structured surface 18 Optical element side 19 Covering 20a Optical path (non-imaging section) 20b Optical path (non-imaging section) 21 Optical path (non-imaging section) 22 Optical path (non-imaging section) 23 Optical path (Non-imaging section) 24 1st optics 25 2nd optics 26 Side walls 27 Imaging section planes 28 Broken lines 100 Devices 200 Drug delivery devices