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Publication numberWO2010115762 A1
Publication typeApplication
Application numberPCT/EP2010/054124
Publication date14 Oct 2010
Filing date29 Mar 2010
Priority date1 Apr 2009
Publication numberPCT/2010/54124, PCT/EP/10/054124, PCT/EP/10/54124, PCT/EP/2010/054124, PCT/EP/2010/54124, PCT/EP10/054124, PCT/EP10/54124, PCT/EP10054124, PCT/EP1054124, PCT/EP2010/054124, PCT/EP2010/54124, PCT/EP2010054124, PCT/EP201054124, WO 2010/115762 A1, WO 2010115762 A1, WO 2010115762A1, WO-A1-2010115762, WO2010/115762A1, WO2010115762 A1, WO2010115762A1
InventorsStephan MÜLLER-PATHLE, Jörg BIGALKE, Claudia Matthias, Irina Lanin
ApplicantSanofi-Aventis Deutschland Gmbh
Export CitationBiBTeX, EndNote, RefMan
External Links: Patentscope, Espacenet
Pen-type drug delivery device with luminous markers
WO 2010115762 A1
Abstract
A pen-type drug delivery device comprises a housing member (1) suitable for containing a drug, a dose setting member (4) which is movable with respect to the housing member (1) in order to set a dose of the drug to be delivered, and a button member (5), wherein the dose is delivered when the button member (5) is moved with respect to the housing member (1) from a first position to a second position. The drug delivery device comprises a luminous marker (30, 31, 32, 33) positioned on at least one of the housing member (1), the dose setting member (4) and the button member (5).
Claims  (OCR text may contain errors)
Claims
1. Pen-type drug delivery device comprising
- a housing member (1 ) suitable for containing a drug,
- a dose setting member (4) which is movable with respect to the housing member (1 ) in order to set a dose of the drug to be delivered,
- a button member (5), wherein the dose is delivered when the button member (5) is moved with respect to the housing (1 ) member from a first position to a second position,
characterised in that the drug delivery device comprises a luminous marker (30, 31 , 32, 33, 34, 35, 36, 37) positioned on at least one of the housing member (1 ), the dose setting member (4) and the button member (5).
2. Pen-type drug delivery device according to claim 1 , characterised in that the marker (30, 31 , 32, 34, 36, 37) is suitable for indicating information about the drug which is contained in the housing member (1 ).
3. Pen-type drug delivery device according to claim 1 or 2, characterised in that the marker (33, 35) is suitable for indicating information about the dose which is set.
4. Pen-type drug delivery device according to any of claims 1 to 3, wherein the marker (34, 35, 37) comprises a scale.
5. Pen-type drug delivery device according to claim 3 or 4, characterised in that the marker (33, 35) is positioned on the dose setting member (4) which is moveable with respect to the housing member (1 ) in order to adjust the dose.
6. Pen-type drug delivery device according to claim 4, characterised in that the housing member (1 ) comprises a cartridge holder and a cartridge, wherein the scale (34, 37) is located on at least one of the cartridge holder and the cartridge.
7. Pen-type drug delivery device according to any of claims 1 to 6, characterised in that the marker (30, 31 , 32, 36) indicates one drug of a multitude of drugs.
8. Pen-type drug delivery device according to any of claims 1 to 7, characterised in that the marker (30, 31 , 32, 33, 34, 35, 36, 37) comprises luminous material.
9. Pen-type drug delivery device according to any of claims 1 to 8, characterised in that the marker (30, 31 , 32, 33, 34, 35, 36, 37) is printed.
10. Pen-type drug delivery device according to any of the claims 1 to 9, characterised in that the marker (30, 31 , 33, 34, 35, 36) comprises a luminous symbol.
11. Pen-type drug delivery device according to any of the claims 1 to 9, characterised in that the marker (32, 37) comprises a luminous background surrounding a symbol.
Description  (OCR text may contain errors)

Description

PEN-TYPE DRUG DELIVERY DEVICE WITH LUMINOUS MARKERS

This disclosure relates to a pen-type drug delivery device.

Document DE 10 2004 063 shows a pen-type drug delivery device and a dose indicator attached to the drug delivery device. The pen-type drug delivery device is suitable for the delivery of several doses of a drug which can be adjusted by a setting member. The attached indicator shows the amount of the dose which is adjusted.

The drug delivery device may be easily recognized or used in a well lit place. But the handling of the drug delivery device may be more difficult in a dark place or in a badly lit place.

It is an aim of the present invention to provide a drug delivery device which can be recognized or used in a dark or badly lit place.

For this aim a pen-type drug delivery device is provided, the pen-type drug delivery device comprising a housing member which is suitable for containing a drug, a dose setting member which is movable with respect to the housing member in order to set a dose of drug to be delivered, and a button member, wherein the dose is delivered when the button member is moved with respect to the housing member from a first position to a second position. The drug delivery device comprises a luminous marker which is positioned on at least one of the housing member, the dose setting member and the button member.

The luminous marker facilitates the handling and recognition of the drug delivery device in dark or badly lit places. One embodiment of the luminous marker glows in the dark. One embodiment of the luminous marker immediately emits the light so that the luminating power of the marker is increased in comparison with a non-luminous marker. A drug delivery device may be a single-dose or multi-use, disposable or re-usable device designated to dispense a selected or fixed dose of a drug, preferably multiple selected or fixed doses of the drug, e.g. insulin, growth hormones, heparin. Preferably the drug delivery device is of the injector-type. The pen-type drug delivery device may have an elongated form which has a tubular or a non-tubular shape. One embodiment is shaped essentially as an ellipsoid. An alternative embodiment is shaped essentially cuboidal. The drug delivery device may have an attachable cap which is suitable for covering a part of the drug delivery device.

The housing member comprises exterior or interior housing parts which are designed to enable safe, correct, and comfortable handling of the drug delivery device. The housing member may be a unitary or a multipart component. The housing member comprises a reservoir which is configured to contain the drug. The reservoir can be formed by outer or inner part parts of the housing member. The reservoir may be fixed or engaged with outer or inner part parts of the housing member. Usually the housing member comprises a cartridge from which a number of doses of the drug may be dispensed. An alternative embodiment of the cartridge is suitable for the delivery of a single dose.

A dose setting member is an element that is moved when a dose of the drug is set. The movement may be a rotational and/or translational movement with respect to the housing member. In one embodiment the dose setting member is designed as a dose setting sleeve which may be designed as a tubular component of essentially circular cross-section.

The button member is a part of the drug delivery device which is moveable with respect to the housing member by the user. The drug is expelled when the button member is moved from a first position to a second position. The button member may be releasably coupled with the dose setting member. In an alternative embodiment the button member and the dose setting member are mounted or integrally formed. The marker is preferably positioned on a visible part of at least one of the housing member, the dose setting member and the button member. In one embodiment the marker is positioned on a part of one of these members, which is visible in an operation state during use of the drug delivery device, e.g. the marker is visible when a dose of the drug is set or when the cap of the drug delivery device is removed.

The marker may be suitable for indicating information about the drug which is contained in the housing member. Alternatively, the marker may be suitable for indicating information about the dose which is set.

A luminous marker comprises an area that exhibits luminescence. In other words, it gives off visible light through fluorescence, phosphorescence, or radioluminescence. In one embodiment the marker is visible under white light. In an alternative embodiment the marker is clear, i.e. not visible, under white light but glows in the dark or under black-light.

Luminescence is an effect that usually occurs at low temperatures. It is a form of cold body radiation. Luminescence may be caused by chemical reactions, electrical energy, subatomic motions or stress on a crystal.

Photoluminescence means that a substance absorbs photons and then re-radiates photons. The period between absorption and emission may be short. However, this period can be extended into minutes or hours under special circumstances.

Resonant radiation, which is a photoluminescent process, means that a photon of a particular wavelength is absorbed and an equivalent photon is immediately emitted. This process can be very fast.

In an alternative process energy transition occurs before emission. Fluorescence is such a process, which is also typically a fast process. Phosphorescence is a specific type of photoluminescence related to fluorescence. Unlike fluorescence, a phosphorescent material does not immediately emit the radiation it absorbs. Absorbed radiation may be emitted at a lower intensity for up to several hours. Phosphorescence is a slow radiative transition process, sometimes lasting minutes or hours. This is the basis for the "glow in the dark" effect.

Common pigments used in phosphorescent materials may comprise zinc sulfide, strontium aluminate and/or strontium oxide aluminate.

At least one of the shape of the marker, the colour of the marker under white light, the intensity of the luminescence and the colour of the luminescence can be used to indicate information about the drug delivery device or its state. The marker may be designed as a symbol, pattern, number, letter or a combination of these.

In one embodiment the marker is suitable for indicating information about the drug which is contained in the housing member. The marker may be designed as a symbol which indicates the information about the content of the drug delivery device, e.g. the type or the concentration of the drug. This information can also be indicated by the colour of the marker. The marker may be designed as a clear word, which means that a luminous lettering indicates the content of the drug delivery device. Alternatively a non-luminous lettering is positioned on a luminous area.

In one embodiment the marker comprises a luminous symbol, which indicates information about the drug, the dose or facilitates recognization of the marker. In one embodiment the marker comprises a luminous background surrounding a symbol.

In one embodiment the marker is suitable for indicating information about the dose which is set. If the drug delivery device is constructed to deliver variable doses of the drug, the marker or a part of the marker indicating the amount of the dose which is set may appear at a given position, e.g. in a window of the housing member. In one embodiment, a number indicating the amount of the dose may be visible in the window. If the drug delivery device is designed as a fixed dose drug delivery device, a symbol may appear at a given position when the dose is set.

Preferably, the marker comprises a scale. The glowing scale is visible in the dark. This marker may be positioned on the dose setting member which is moved with respect to the housing member when the dose is adjusted.

In one embodiment the housing member comprises a cartridge holder and a cartridge, wherein the scale is located on at least one of the cartridge holder and the cartridge. The marker may be designed as a scale which facilitates reading of the scale in the dark in order to get information about the drug provided in the drug delivery device.

The marker may be suitable for indicating one drug of a multitude of drugs. This means that one of the multitude of drugs is represented by one symbol from a multitude of symbols. In other words, a first drug, e.g. a first type of insulin, is indicated by a first symbol and a second drug, e.g. a second type of insulin, is indicated by a second symbol.

In one embodiment the marker comprises luminous material. In one embodiment the marker is printed by luminous paint. Printing may be performed after manufacturing the drug delivery device or during the delivery process, e.g. before mounting the parts of the drug delivery device.

Luminous paint is paint that exhibits luminescence. Visible light is given off by fluorescence, phosphorescence, or radioluminescence.

Fluorescent paint may react to ultraviolet light, also known as black light. Ultraviolet sensitive pigments absorb black light and emit visible light.

There are two basic kinds of fluorescent paint: visible paint and invisible paint. Visible fluorescent paint can appear as any bright colour under white light, and glows brilliantly under black light. Invisible fluorescent paint appears white or clear under white light, but glows a particular colour, which depends on the pigment used, under black light. Invisible fluorescent paint can be used to create black-light effects.

Phosphorescent paint glows in the dark. It may comprise phosphors such as silver- activated zinc sulfide or doped strontium aluminate. Phosphorescent paint typically glows a pale green to greenish blue color. Phosphorescent paints have a sustained glow which lasts for some minutes or hours after exposure to light, but will eventually fade over time. The mechanism for producing light is similar to that of fluorescent paint, but the emission of visible light persists for some time after it has been exposed to light.

Radioluminescent paint comprises a radioactive isotope combined with a radioluminescent substance. The isotopes are typically strong emitters of fast electrons. Radioluminescent paints will glow without exposure to light until the radioactive isotope has decayed, which may be many years.

Further features and refinements become apparent from the following description of the exemplary embodiments in connection with the accompanying figures.

Figure 1 schematically shows an embodiment of a drug delivery device having luminous markers.

Figure 2 schematically shows a further embodiment of a drug delivery device having luminous markers.

Figure 3 schematically shows a further embodiment of a drug delivery device having luminous markers.

Figure 1 schematically shows an embodiment of a pen-type drug delivery device having luminous markers. The pen-type drug delivery device has a housing member 1 comprising a distal housing part 21 and a proximal housing part 22. The housing member 1 is configured to contain a drug and at least parts of a driving mechanism which is suitable to set a dose of the drug and to expel the dose from the drug delivery device.

The drug is contained in a reservoir 15 located in the distal housing part 21. The reservoir 15 is formed as a cartridge located inside the distal housing part 21.

The housing member 1 comprises a first window 7 which shows the content of the reservoir 15. The reservoir 15 can be fabricated from a transparent, partially transparent or translucent material, so as to allow a user to view the content of the reservoir through the first window 7. A second window 8 is located at the proximal housing part 22, the second window 8 showing a part of the driving mechanism. The second window 8 may suitable for indicating the status of the driving mechanism. In one embodiment the first and second windows 7, 8 are designed as cut-outs in the housing member 1.

The housing member 1 further comprises a cap 9 which can be attached to the distal housing part 21 so that the distal housing part 21 is covered, e.g. if the drug delivery device is not used. The cap 9 is removable, e.g. before use of the drug delivery device.

A first luminous marker 30 is positioned on the proximal housing part 22. In one embodiment the first marker 30 is designed as a circumferential surrounding pattern which comprises luminous design elements so that the pattern is visible in the dark. In this embodiment a multitude of stripes, which are arranged in parallel, forms the pattern. In one embodiment the pattern is printed by a luminous colour. In an alternative embodiment the pattern is printed on a film which serves as a label, wherein the label is attached to the housing member 1. In an alternative embodiment the pattern is formed by luminous material inserted into the proximal housing part 21.

A second luminous marker 31 and a third luminous marker 32 are positioned on the cap 9. The second marker 31 is designed as a luminous symbol. One embodiment of the second marker 31 is formed as a luminous film label which is attached to the cap 9. The third marker 32 comprises a luminous background which surrounds a non- luminous symbol. In one embodiment the third marker 32 is formed as a luminous film label having a cut-out shape as a symbol, the film being attached to the cap 9.

A needle unit 2 having a needle 3 is located at the distal end of the housing member 1 facing a patient's skin during medication. The needle unit 2 is configured to deliver the drug through the needle 3. Through the needle 3 of the needle unit 2 the drug can be injected into the patient. The needle unit 2 can be secured to the housing member 1 by a threaded engagement. The needle unit 2 forms a part of the distal housing part 21 , for example.

Delivery of the drug can be performed by means of the drive mechanism which comprises a piston member 6, a dose setting member 4, and a button member 5. The drive mechanism is configured to set a dose of the drug and to move the piston member 6 in the distal direction such that the set dose is dispensed from the reservoir 15 when the button member 5 of the drug delivery device is pressed. In general, embodiments of the invention are not restricted to a specific configuration of the drive mechanism.

The piston member 6 is located inside the distal housing part 21 and/or the proximal housing part 22, the piston member 6 being moveable in the distal direction with respect to the housing member 1 along inside walls of the reservoir 15. In one embodiment the piston member 6 rotationally moves with respect to the housing member 1 when the piston member 6 moves in the distal direction. The drug is expelled through the needle 3 when the piston member 6 moves distally along the inside walls of the reservoir 15. The position of the distal end of the piston member 6 is visible through the first window 7, which indicates the amount of drug remaining in the reservoir 15. In general, embodiments of the invention are not restricted to a specific configuration of the piston member 6.

The dose setting member 4 is at least partly located inside the proximal housing part 22. One embodiment of the dose setting member 4 is designed as a dose sleeve which is tubular shaped. The dose setting member 4 is moveable so that a dose to be delivered is set. In one embodiment the dose sleeve is moveable in an axial direction with respect to the housing member 1. In an alternative embodiment the dose setting member 4 is rotatable with respect to the housing member. In one embodiment the dose is set when the dose setting member 4 is transversally and rotationally moved with respect to the housing member 1. In general, embodiments of the invention are not restricted to a specific configuration of the dose setting member 4.

The drug delivery device shown in figure 1 is configured to deliver a fixed dose. The fixed dosed is set when the dose setting member 4 is moved from a first position to a second position. The proximal part of the dose setting member 4 is located inside the proximal housing part 22 in the first position. The proximal part of the dose setting member 4 protrudes from the proximal housing part 22 in the second position. Figure 1 shows the dose setting member 4 positioned in the second position.

The second window 8 shows a part of the dose setting member 4. The part which is shown depends on the position of the dose setting member 4. A fourth luminous marker 33 is positioned on the dose setting member 4 so that the fourth marker 33 is visible through the second window 8 when the dose sleeve is located in the second position. The fourth marker 33 indicates that the dose is set. In one embodiment a further marker (not shown) is visible when the dose setting member 4 is located in the first position.

A button member 5 is located adjacent to a proximal end of the housing member 1. In this embodiment the dose setting member 4 and the button element are integrally formed. The drive mechanism is configured so that the dose is delivered when the button element 5 is moved with respect to the housing member 1 from a first position to a second position. In one embodiment the button member 5 is pushed in the distal direction with respect to the housing member 1. In general, embodiments of the invention are not restricted to a specific configuration of the button member 5.

Before use the cap 9 is removed from the distal housing part 21. In use of the drug delivery device, the dose setting member 4 is moved from the first position to the second position when the button member 5 is pulled in the proximal direction with respect to the housing member 1. The fixed dose is set by the proximal movement of the dose setting member 4. The fourth marker 33 which indicates that the dose is set is visible in the second window 8 when the dose setting member 4 reaches the second position.

When the button member 5 is pushed in the distal direction with respect to the housing member 1 the piston member 6 moves to the distal direction and along the reservoir 15 which contains the drug. The fixed dose of the drug is expelled through the needle 3 when the piston member 6 moves distally. The movement of the distal end of the piston member 6 is visible through the first window 1.

The luminous markers 30, 31 , 32, 33 facilitate the recognition and use of the drug delivery device in a dark or badly lit place.

The first, second and third markers 30, 31 , 32 are located on visible parts of the drug delivery devices. The luminous markers are suitable for indicating the position of the drug delivery device. The user can recognize the glowing luminous markers 30, 31 , 32 in a dark or badly lit place. The luminous markers 30, 31 , 32 facilitate finding the drug delivery device in the user's bag, for example.

The markers are also suitable for recognizing the drug delivery device. For this purpose the markers may be individually positioned by the user in order to personalize the drug delivery device so that the user can recognize his or her drug delivery device. In one embodiment the user attaches a combination of luminous symbols to the drug delivery device. The symbols may be designed as numbers, letters or pictograms.

The marker may be suitable for indicating information about the drug which is contained in the housing member 1. In one embodiment the pattern of the first marker 30 represents a drug from a multitude of drugs, e.g. a type of insulin. In one embodiment the marker is suitable for indicating the drug or the type of drug which is contained in the drug delivery device. For example, a first pattern represents a first type of insulin and a second pattern represents a second type of insulin. In one embodiment a first marker having a first colour represents a first type of insulin and a second marker having a second colour represents a second type of insulin. In general, embodiments of the invention are not restricted to a specific group of drugs.

Markers indicating information about the drug can be positioned to the housing member 1 , e.g. the cap 9 or the proximal housing part 22, or the button member 5. The markers are preferably also visible even if the drug delivery device is not in use.

In one embodiment (not shown) the marker is designed as luminous lettering which indicates the name or type of the drug. An alternative embodiment of the lettering indicates a warning or instruction for use. In one embodiment the marker is designed as luminous lettering on a dark background. In an alternative embodiment the marker is designed as dark lettering on a luminous background.

The description of the following embodiments concentrates on features which are different from the embodiment shown in figure 1. The same reference numerals apply for the description of the following figures as for the description of Figure 1.

Figure 2 shows an alternative embodiment of the of a drug delivery device having luminous markers. A cap is not shown for clarity reasons.

The drug delivery device comprises a needle unit 2 located at the distal end of the housing member 1 and a drive mechanism which comprises a piston member 6, a drive setting member 4 and a button member 5.

The housing member 1 which comprises distal and proximal housing parts 21 , 22 has a first window 7 showing the content of the reservoir 15 which is designed as a cartridge. The distal housing part 21 serves as a cartridge holder. The position of the distal part of the piston member 6 is visible through the first window 7. A first marker 34 is positioned on the distal housing part 21. The marker 34 is designed as a scale comprising a multitude of luminous scale lines 28. In this embodiment, numbers are assigned to the scale lines 28, the numbers being luminous numbers preferably positioned on a dark background. In one embodiment the numbers are also luminous. The position of the distal part of the piston member 6 with respect to the scale clearly indicates the amount of drug which is provided in the drug delivery device. In this embodiment the scale is positioned on the cartridge 15 and on the distal housing member 21. In one embodiment (not shown) the scale 24 is positioned only on the cartridge 15. In an alternative embodiment (not shown) the scale is positioned only on the distal housing part 21.

The drive mechanism is configured to set a variable dose of the drug and then expel this dose. The drive mechanism comprises the piston member 6, a button member 5 and a dose setting member 4, which comprises a scale having a multitude of numbers. The dose setting member 4 is embodied as a dose sleeve.

During setting the dose setting member 4 rotates and moves in the proximal direction with respect to the housing member 1. One of the numbers is visible in a second window 8 located in the distal housing part 22. The number which is visible depends on the position of the dose setting member 4. This number indicates the amount of the dose which is set.

The numbers serves as second marker 35 of the drug delivery device. In an alternative embodiment the numbers are designed as dark non-luminous numbers positioned on a luminous background. The dose setting member 4 may be made of a luminous material. The set dose is indicated by the position of the scale with respect to a given part of the housing member 1. In other words, the number which is visible in the second window 8 indicates the set dose and depends on the position of the dose setting member 4 which is moved during dose adjustment. The markers 34, 35 facilitate use of the drug delivery device in a dark or badly lit place. The user can see the amount of drug provided in the drug delivery device and the set dose.

Figure 3 shows an alternative embodiment of a variable dose drug delivery device having luminous markers. A cap is not shown for clarity reasons. The drug delivery device comprises a housing member 1 and a drive mechanism.

The variable dose pen-type drug delivery device has a button element with a first luminous marker 36. The luminous marker 36 is designed as a pattern of luminous structures. This marker 36 is suitable for recognizing the drug delivery device in a dark place. In one embodiment the pattern indicates information about the drug contained in the drug delivery device.

The distal housing part 21 serves as a cartridge holder for the reservoir 15 designed as a cartridge. A second marker 37 is positioned on the cartridge. The second marker 37 is designed as a luminous label having a non-luminous scale with scale lines 28. In one embodiment the label is a transparent, partially transparent or translucent luminous film, so as to allow a user to view the content of the reservoir. In an alternative embodiment the label is made from a transparent, partially transparent or translucent material, on which luminous symbols are printed.

The label can be easily attached to the reservoir 15 after manufacturing the drug delivery device.

The term "drug" or "medicament", as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound,

wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis,

wherein in a further embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy,

wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1 ) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4.

Insulin analogues are 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; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, VaI or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

Insulin derivates are for example B29-N-myhstoyl-des(B30) human insulin; B29-N- palmitoyl-des(B30) human insulin; B29-N-myhstoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myhstoyl LysB28ProB29 human insulin; B28-N-palmitoyl- LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N- palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ω- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin. Exendin-4 for example means Exendin-4(1 -39), a peptide of the sequence H-His-Gly- Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-GIn-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.

Exendin-4 derivatives are for example selected from the following list of compounds:

H-(Lys)4-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,

H-(Lys)5-des Pro36, des Pro37 Exendin-4(1 -39)-NH2, des Pro36 [Asp28] Exendin-4(1-39), des Pro36 [lsoAsp28] Exendin-4(1 -39), des Pro36 [Met(O)14, Asp28] Exendin-4(1-39), des Pro36 [Met(O)14, lsoAsp28] Exendin-4(1 -39), des Pro36 [Trp(O2)25, Asp28] Exendin-4(1 -39), des Pro36 [Trp(O2)25, lsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, lsoAsp28] Exendin-4(1 -39); or

des Pro36 [Asp28] Exendin-4(1-39), des Pro36 [lsoAsp28] Exendin-4(1 -39), des Pro36 [Met(O)14, Asp28] Exendin-4(1-39), des Pro36 [Met(O)14, lsoAsp28] Exendin-4(1 -39), des Pro36 [Trp(O2)25, Asp28] Exendin-4(1 -39), des Pro36 [Trp(O2)25, lsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1 -39), des Pro36 [Met(O)14 Trp(O2)25, lsoAsp28] Exendin-4(1 -39), wherein the group -Lys6-NH2 may be bound to the C-terminus of the Exendin-4 derivative;

or an Exendin-4 derivative of the sequence

H-(Lys)6-des Pro36 [Asp28] Exendin-4(1 -39)-Lys6-NH2, des Asp28 Pro36, Pro37, Pro38Exendin-4(1 -39)-NH2, H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1 -39)-NH2, H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(l_ys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(l_ys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(l_ys)6-NH2, H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1 -39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1 -39)-(l_ys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1 -39)-(l_ys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1 -39)-(l_ys)6-

NH2,

H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2, des Met(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-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-(l_ys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-(Lys)6- NH2,

H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1 -39)-Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25] Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1 - 39)-NH2, des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(l_ys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(S1-39)- (Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1- 39)-(Lys)6-NH2; or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exedin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Thptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxapahn sodium.

Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCI or HBr salts. Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1 )(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 -C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6- C10-heteroaryl group. Further examples of pharmaceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology.

Pharmaceutically acceptable solvates are for example hydrates.

Other implementations are within the scope of the claims. Elements of different embodiments may be combined to form implementations not specifically described herein. Reference numerals

1 housing member

2 needle unit

3 needle

4 dose setting member

5 button member

6 piston member

7, 8 window

9 cap

15 reservoir

21 distal housing member

22 proximal housing member

28 scale line

30, 31 , 32, 33 marker

34, 35, 36, 37 marker

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Reference
1ALFONSO R. GENNARO: 'Remington's Pharmaceutical Sciences" 17. ed.', 1985, MARK PUBLISHING COMPANY
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
WO2012020089A1 *11 Aug 201116 Feb 2012Sanofi-Aventis Deutschland GmbhDifferentiation for a drug delivery device
EP2659902A1 *30 Apr 20136 Nov 2013Sun Pharmaceutical Industries LimitedLeuprolide injection
US96560234 Feb 201423 May 2017Sun Pharmaceutical Industries LimitedLeuprolide injection
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Classifications
International ClassificationA61M5/24
Cooperative ClassificationA61M5/3158, A61M2205/6081, A61M2205/587, A61M5/31551, A61M5/24, A61M5/3129, A61M2005/3125, A61M5/31525
European ClassificationA61M5/31C, A61M5/24
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