DK2415041T3 - PROCEDURE FOR PREPARING A BODY FOR A PHARMACEUTICAL ADMINISTRATION USING AN ADHESIVE AND A BODY FOR A PHARMACEUTICAL ADMINISTRATION DEVICE - Google Patents

Description

DESCRIPTION

[0001] The present invention is defined in the appended claims and relates to a method for manufacturing a drug delivery device body, particularly of a portable drug delivery device, especially a pen-type drug delivery device or injection pen.

Portable drug delivery devices are generally known for the administration of a medicinal substance or fluid, for example insulin, growth hormones or other drugs, being suitable for selfadministration by a patient. A drug delivery device is especially useful in the shape of a pen, which can be handled easily and kept everywhere available. A sophisticated type of drug delivery device is constructed to be refillable and reusable many times. To secure a long life of the device, it is important to avoid damages caused during every day use.

Some drug delivery devices are constructed to deliver a plurality of different doses. One particular example of such a drug delivery device is described in EP1923083A1. The drug delivery device shown therein allows a user to activate the delivery device. For that purpose, the drug delivery device includes a drive mechanism suitable for use in pen-type injectors, where an amount of pre-set doses of a medicinal product can be administered. A needle unit can be attached to the drug delivery device for dispensing the medicinal product into a patient's body.

[0002] A further apparatus for supplying medicine (for infusion) portable by a patient is given in US2005/209562 A1.

[0003] Necessary information about the drug delivery, the dosage or the particular drugs contained in the drug delivery device should be directly accessible by the user of the device and should therefore be visual on the body of the device. Further, with respect to patients using two different types of drugs it is helpful, if the patient has one device (for example one pen) for one type of drug and another device (for example pen) for the other type of drug. To avoid a mix-up between the two drugs, it is necessary to make the drug delivery devices distinguishable.

[0004] It is an object of the present invention to provide a method for fixing a first part of a drug delivery device body to a second part of a drug delivery device body. It is a further object of the present invention to provide a method which allows to fix a part containing information or an element making the drug delivery device distinguishable to a second part of the drug delivery device body.

[0005] This object is achieved with the subject matter of the independent claims. Embodiments derive from the dependent claims.

[0006] The method for manufacturing a drug delivery device body (or a housing of a drug delivery device) according to the present invention comprises the following steps: 1. A) A first part of the drug delivery device is provided; this first part has one or more selected areas and one or more non-selected areas on its surface. This selected area(s) are part(s) of the contact area(s) of the first part of the drug delivery device body and a second part of the drug delivery device body which is to be fixed to the first part. In other words: the selected area is the area completely covered by the second part of the drug delivery device body after having fixed the second part to the first part of the drug delivery device body. 2. B) In a second step, a layer of an adhesive is deposited on the surface of the first part of the drug delivery device body; in order to allow a selective deposition of the adhesive only in the selected areas (and not in the non-selected areas), deposition means are used which particularly allow a precise deposition. 3. C) In a further step the first and the second part of the drug delivery device body are joined and the first part of the drug delivery device body is fixed to the second part by the adhesive. The joining of the two parts is realized in a way that after joining the layer of the adhesive is arranged in the contact area of the first and the second part of the drug delivery device body only (and does not cover any part of a non-selected area). Usually also the adhesive and/or the thickness of the layer of adhesive are selected so as to achieve a result where no part of a non-selected area is covered with adhesive.

[0007] According to the present invention, "contact area(s)" describe the area of the drug delivery device body where the second part of the drug delivery device body is fixed or is to be fixed to the first part of the drug delivery device body; the contact area comprises the selected areas and the non-selected areas on the first and the second part of the drug delivery device body as well as the layer of adhesive (and usually consists of these areas and this layer). Therefore, the contact area is the area of the first and the area of the second part of the drug delivery device body being invisible after joining of the two parts; further, the contact area comprises the area where an adhesive force fixes the first part to the second part (after joining the two parts).

[0008] A "drug delivery device body" may comprise the outer housing of the drug delivery device. Particularly, the drug delivery device and the outer housing of the drug delivery device are identical.

[0009] The method of the present invention enables an easy and an economic way to manufacture a drug delivery device body. As no adhesive is present in non-selected areas (particularly in areas where no adhesive should be present as no other part is to be fixed to these areas) negative effects on the further assembly of the drug delivery device body or the drug delivery device in general can be reduced. Further, residues of the adhesive on the outer surface of the drug delivery device can be avoided. Particularly, the joining step has no influence on the haptics of the drug delivery device (and no influence on the distinguishability of different drug delivery devices).

[0010] The means for deposition of the adhesive which allow a precise deposition of the adhesive particularly may be devices for applying the adhesive, for example printing devices or a part of these devices. Additionally of alternatively, separate tools like stencils or masks can be used as means for deposition of the adhesive. The means for deposition of the adhesive particularly allow a deposition of the adhesive so that the selected areas are completely covered with adhesive or alternatively a deposition where only a part of the selected areas is covered and the section bordering the non-selected areas is uncovered. Such a way of covering the selected and non-selected areas of the surface enables a joining step, where the area being covered with adhesive is being enlarged but not to an extent that also non-selected areas are covered with adhesive.

[0011] According to an embodiment of the invention, the adhesive is deposited on the surface of the respective part of the drug delivery device by pad printing or by spraying of the adhesive. Both methods allow the deposition of a defined amount of the adhesive and the application of a particularly thin layer of adhesive.

[0012] For both methods the adhesive can be selected from the group consisting of pressure sensitive adhesives, drying adhesives, contact adhesives, hot melt adhesives and chemical setting adhesives. Concerning chemical setting adhesives even two-component adhesives can be used, also if the adhesive is sprayed on the surface of the respective part of the drug delivery device body.

[0013] The use of pressure sensitive adhesives and drying adhesives enables a very easy method of joining. If drying adhesives are used a very quick (and economic) procedure is possible as the solvent or the dispersion medium comprised in these drying adhesives evaporates during the joining step.

[0014] If chemical setting adhesives are used, usually a higher bonding strength can be obtained. Chemical setting adhesives may, therefore, be used for parts of the drug delivery device body where high mechanical stress can occur. Concerning chemical setting adhesives in principle all known adhesives are possible: e.g. two-component adhesives and one-component adhesives are possible. The hardening of the one-component adhesives can be induced by temperature, light or ultrasonic. However, the use of (visible or UV-) light usually requires at least one transparent part of the drug delivery device body or a part of the drug delivery device body having a transparent section in the area being joined to the other part of the drug delivery device body.

[0015] In a further embodiment a mask is used for the deposition of the adhesive on the selected areas. By use of a mask, the non-selected areas can be covered; a very precise deposition of the adhesive is possible. A mask will often be used, if the adhesive is deposited on the surface of the part of the drug delivery device body by spraying as usually no adhesives will soak between the mask and the surface of the part of the drug delivery device body part.

[0016] In a further embodiment, the mask does not only cover the non-selected areas; also a part of the selected areas, particularly the part bordering the non-selected areas, is covered (for example 10 to 15% of the selected area may be covered in the section bordering the non-selected areas). If also the selected areas partially covered, a soaking of the adhesive (or solution or dispersion of the adhesive) between the mask and the part of the drug delivery device body covered by the mask may be tolerated to a certain extent. Further, such a way of covering the selected and non-selected areas of the surface enables a joining step, where the area being covered with adhesive is enlarged (for example due to the imposed pressure) but not to an extent that also non-selected areas are covered with adhesive.

[0017] In a further embodiment, bulks or spacers may be present in the selected areas. Such raised surfaces in the selected areas may be used to control the thickness of the adhesive layer (and to prevent an enlargement of the adhesive layer upon pressing the two parts of the drug delivery device body against each other).

[0018] In a further embodiment, particularly if a contact adhesive is used, a second layer of the adhesive is deposited on a second selected area on the second part of the drug delivery device body. This second selected area corresponds to the selected area of the first part of the drug delivery device body. In order to avoid the deposition of adhesive from the second layer of adhesive to non-selected areas of the first part of the drug delivery device body only the area corresponding to the selected areas of the first part of the drug delivery device body are coated with adhesive. In other words: only the area of the second part of the drug delivery device body being invisible after joining of the two parts of the drug delivery device body is (at least partially) covered with adhesive.

[0019] In a further embodiment, the first or the second part of the drug delivery device body is indicative for the drug contained in the drug delivery device. In particular, the first or the second part of the drug delivery device body may be an element of design making it easy for a user to distinguish two different drug delivery devices.

[0020] A part being indicative for the drug contained in the drug delivery device may for example provide a three-dimensional surface structure enabling a user of the drug delivery device to distinguish two different drug delivery devices by different haptics. Even for a user with impaired vision, such a drug delivery device (for example with a "structure" being Braille) provides the possibility to distinguish drug delivery devices by feeling the surface of the drug delivery device body.

[0021] Further, the (indicative) part may be colored (but can also be colored after the manufacturing process).

[0022] In a further embodiment the first or the second part of the drug delivery device body is a label, particularly a label containing a piece of information. The information may be printed or structured on the surface of the label.

[0023] In a further embodiment, the first or the second part of the drug delivery device body is a transparent cover. The cover may protect information being displayed underneath the cover.

Furthermore, the transparent cover may cover a window aperture. A window aperture may be useful to allow at least one symbol representing dosage information to be visible, wherein the symbol(s) representing dosage information are changed during operation of the drug delivery device.

[0024] The transparent cover (as well as the first and the second part of the drug delivery device in general) may comprise plastics or may consist of plastics. The transparent cover, in particular, may comprise a scratch-resistant material on its outer surface to prevent or reduce damage due to gliding or scratching of the drug delivery device along a surface.

[0025] In a further embodiment, a recess is arranged in the surface of the first or the second part, wherein at least a part of the selected area of the first part (or the second part) covers at least a section of surface of the recess.

[0026] If such a recess is present in the surface, the two joined parts of the drug delivery device body can sustain more mechanical stress. If the first or the second part of the drug delivery device body is a transparent cover having a thickness being less than or at most equal to the depth of the recess, the outer surface of the transparent cover is protected from being scratched or damaged during usage or storing of the drug delivery device even more. If a mask is used in the present invention, the recess may serve as support for the exact adjustment of the mask.

[0027] In an embodiment of the drug delivery device body, it is intended for a pen-type device of elongated shape, provided at one end with an operation button. The smaller part of the two parts of the drug delivery device body, particularly a part being indicative for the drug contained in the drug delivery device or a part containing information, is located near the end of the body where the operation button is to be placed.

[0028] The term "drug", 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.

[0029] 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, Val 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.

[0030] Insulin derivates are 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-myristoyl 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-((O-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-((O-carboxyheptadecanoyl) human insulin.

[0031] 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-lle-Glu-

Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

[0032] 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(0)14, Asp28] Exendin-4(1-39), des Pro36 [Met(0)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(0)14 Trp(O2)25, Asp28] Exendin-4(1-39), des Pro36 [Met(0)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)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)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)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)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(0)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Lys6-des Pro36 [Met(0)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38 [Met(0)14, Trp(O2)25] Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Met(0)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2 H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Trp(O2)25, Asp28] Exendin-4(S1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)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.

[0033] 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, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.

[0034] 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 enoxaparin sodium.

[0035] 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.

[0036] Pharmaceutically acceptable solvates are for example hydrates.

[0037] In another embodiment, the body is part of an assembled drug delivery device, especially an injection pen or a syringe.

[0038] According to a further aspect of the present invention, a drug delivery device body is provided. The drug delivery device body comprises a first part and a second part; the first part and the second part are joined to each other by means of a layer of an adhesive. Outside the adhesive joint no adhesive is present.

[0039] The drug delivery device according to the invention, therefore, enables an easy assembly of the whole drug delivery device; also on the outer surface of the drug delivery device body no adhesive is present and it is unproblematic to distinguish two different types of drug delivery devices, particularly due to different haptics on the surface of the drug delivery device.

[0040] Other features of examples and embodiments of the invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings.

Figure 1 and figure 2 show a part of an embodiment of a pen-type drug delivery device body according to the invention.

Figures 3A to C show in a cross-section the process of joining two parts of a drug delivery device body.

Figure 4A and B show in a cross-section the process of joining two parts of the drug delivery device body, wherein one part has a recess.

[0041] The figures show additional features that are not essential for the invention and are represented by way of illustration only. The figures are not drawn to scale.

[0042] Figure 1 shows a first part 1 of an embodiment of a pen-type drug delivery device comprising a recess 9 and an aperture for secure retention of an inner part of the drug delivery device. Inside the recess 9, the selected area 5 is defined by a dashed line (for the sake of clarity of the drawing, this line rather resembles an area covered with adhesive where the section of the selected areas bordering the non-selected areas is not covered with adhesive). The dashed line does not enclose the aperture 14; therefore, adhesive deposited in the selected area 5 cannot cause any problems concerning the further assembly of the drug delivery device. The second part 2 of the drug delivery device body to be joined with the first part 1 shows a second selected area 8 corresponding to the selected area 5 of the first part 1 of the drug delivery device. Adhesive may also be deposited on the second selected area 8. After joining of the first part 1 and the second part 2 no problems are caused concerning the further assembly and the aperture 14.

[0043] Figure 2 shows a further view of an embodiment of a pen-type drug delivery device comprising a first part of the body 1 with a recess 9 extending from one end of the pen to the other end. The recess comprises a window aperture 12 (for example to enable the display of dosage information). The dashed line inside the recess defines two separate selected areas 5 (for the sake of clarity of the drawing, these lines rather resemble areas covered with adhesive where the section of the selected areas bordering the non-selected areas is not covered with adhesive). The method according to the present invention enables a procedure where no adhesive is present in the area surrounding or extending into the window aperture 12 or jutting out on one of the ends of the first part 1. Therefore, the adhesive cannot cause any problems concerning a further assembly of the drug delivery device or concerning a complete display of dosage information. The second part 2 of the drug delivery device body comprises a transparent section 10 (which may be joined with the not transparent part of the second part 2 of the drug delivery device body according to the method of the present invention). The transparent section 10 (or the not transparent part) may contain a lettering 13 (for example the name, a trademark or information).

[0044] Figures 3Ato 3C show the procedure how to manufacture a drug delivery device body according to the present invention in a cross-section. Figure 3A shows a first part 1 of the drug delivery device body having several selected areas 5 and non-selected areas 6. Figure 3B shows the situation after deposition of the layer of adhesive. In each of the selected areas 5 a layer of an adhesive 3 is arranged. The layer of adhesive 3 does not extend until the border between selected areas 5 and non-selected areas 6 in order to allow a certain enlargement of the film during the joining process (for example upon pressure being imposed). Figure 3C shows the situation after joining of the first part 1 and a second part 2. The second part 2 of the drug delivery device body consists of a transparent section 10 and a non-transparent section 11. The layer of adhesives extends until the borders between the selected areas 5 and the non-selected areas 6 (for example due pressure having been imposed during the joining step). The non-selected area 6 underneath the second part 2 of the drug delivery device body, therefore, is not covered with adhesive. Therefore, the surface of the first part 1 of the drug delivery device or a not shown window aperture in the surface of the first part 1 of the drug delivery device body is visible through the transparent part 10 of the second part of the drug delivery device body 2.

Figures 4A and 4B show a cross-section of the joining procedure wherein one of the parts of the drug delivery device body to be joined comprises a recess. The first part 1 of the drug delivery device body comprises a selected area 5 corresponding to the recess 9 in the first part of the drug delivery device body 1. Figure 4A further shows a layer of an adhesive 3 deposited on the selected area 5. A second part 2 of the drug delivery device body is being joined to the first part 1. The second part 2 shows a selected area 8 corresponding to the selected area 5 of the first part 1 of the drug delivery device body. On this second selected area 8 a second layer of the adhesive 7 was deposited (figure 4A, therefore, shows a process where for example a contact adhesive is used; if no contact adhesive is used, usually the second layer 7 of the adhesive may be omitted). On the surface of the second part 2 facing away from the first part of the drug delivery device 1 a part of a lettering 13 (or a structure enabling a design of the device or different haptics of the device) can be seen. Figure 4B shows the situation after joining. The adhesive is omitted for overview reasons. The adhesive does not extend the area of the adhesive joint 4.

Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the scope of the invention as defined by the appended claims. Also features described in conjunction with various embodiments can be combined in different ways provided that they are not departing from the scope of the appended claims.

Reference numerals [0045] 1 first part of the drug delivery device body 2 second part of the drug delivery device body 3 layer of adhesive 4 adhesive joint 5 selected area on the surface of the first part of the drug delivery device body 6 non selected area on the surface of the first part of the drug delivery device body 7 second layer of adhesive 8 selected area on the surface of the second part of the drug delivery device body 9 recess 10 transparent section 11 non transparent section 12 window aperture 13 lettering 14 aperture

REFERENCES CITED IN THE DESCRIPTION

This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

Patent documents cited in the description • EP1923Q83A1 [60011 • US2005209562A1 [00021

Non-patent literature cited in the description • Remington's Pharmaceutical SciencesEncyclopedia of Pharmaceutical TechnologyMark Publishing Companyl 9850000 [09351

Claims (14)

1. Fremgangsmåde til fremstilling af et legeme til en lægemiddeladministrationsanordning, som omfatter trinene: A) tilvejebringelse af en første del (1) af legemet til en lægemiddeladministrationsanordning med mindst ét udvalgt område (5) og mindst ét ikke-udvalgt område (6) på overfladen af den første del (1) af legemet til en lægemiddeladministrationsanordning, hvor det udvalgte område (5) er en del af kontaktområdet mellem den første del (1) af legemet til en lægemiddeladministrationsanordning og en anden del (2) af legemet til en lægemiddeladministrationsanordning, der skal fastgøres til den første del (1) af legemet til en lægemiddeladministrationsanordning, B) påføring af et lag af et klæbemiddel (3) på overfladen af den første del, hvor der tilvejebringes et påføringsmiddel til udvalgt påføring af klæbemidlet alene i det udvalgte område (5) , C) samling af den første og den anden del (1, 2) af legemet til en lægemiddeladministrationsanordning, således at laget af klæbemiddel kun er anbragt i kontaktområdet på den første og den anden del (1, 2) af legemet til en lægemiddeladministrationsanordning og ikke dækker nogen del af det ikke-udvalgte område (6) .A method of preparing a body for a drug delivery device comprising the steps of: A) providing a first portion (1) of the body to a drug delivery device having at least one selected region (5) and at least one non-selected region (6) in the surface of the first portion (1) of the body for a drug delivery device, wherein the selected region (5) is a portion of the contact area between the first portion (1) of the body of a drug delivery device and a second portion (2) of the body of a drug delivery device B) applying a layer of an adhesive (3) to the surface of the first portion providing an application agent for selected application of the adhesive only in the selected part. area (5), C) joining the first and second parts (1, 2) of the body to a drug delivery device so that For example, it is directed that the adhesive layer is located only in the contact area of the first and second portions (1, 2) of the body for a drug delivery device and does not cover any portion of the unselected region (6). 2. Fremgangsmåde ifølge ovennævnte krav, hvor trin B) omfatter pudetrykning af klæbemidlet.A method according to the preceding claim, wherein step B) comprises cushioning the adhesive. 3. Fremgangsmåde ifølge krav 1, hvor trin B) omfatter sprøjtning af klæbemidlet.The method of claim 1, wherein step B) comprises spraying the adhesive. 4. Fremgangsmåde ifølge et af ovennævnte krav, hvor klæbemidlet er valgt fra gruppen, der består af trykfølsomme klæbemidler, tørrende klæbemidler, kontaktklæbemidler, varmesmeltende klæbemidler og kemiske hærdende klæbemidler.A method according to any one of the preceding claims, wherein the adhesive is selected from the group consisting of pressure sensitive adhesives, drying adhesives, contact adhesives, heat melt adhesives and chemical curing adhesives. 5. Fremgangsmåde ifølge et af ovennævnte krav, hvor midlet til påføring af klæbemidlet omfatter en afdækning, der dækker det ikke-udvalgte område (6).A method according to any one of the preceding claims, wherein the means for applying the adhesive comprises a covering covering the unselected area (6). 6. Fremgangsmåde ifølge et af ovennævnte krav, hvor et andet lag af klæbemidlet (7) i trin B) påføres på et andet udvalgt område (8) af den anden del (2) af legemet til en lægemiddeladministrationsanordning, hvor det andet udvalgte område (8) svarer til det udvalgte område (5) af den første del (1) af legemet til en lægemiddeladministrationsanordning.A method according to any one of the preceding claims, wherein a second layer of the adhesive (7) in step B) is applied to a second selected region (8) of the second part (2) of the body to a drug delivery device, wherein the second selected region ( 8) corresponds to the selected region (5) of the first part (1) of the body to a drug delivery device. 7. Fremgangsmåde ifølge et af ovennævnte krav, hvor den første eller den anden del (1, 2) af legemet til en lægemiddeladministrationsanordning viser hvilket lægemiddel, der er indeholdt i lægemiddeladministrationsanordningen.A method according to any one of the preceding claims, wherein the first or second portion (1, 2) of the body of a drug delivery device shows which drug is contained in the drug delivery device. 8. Fremgangsmåde ifølge et af ovennævnte krav, hvor den første eller den anden del (1, 2) af legemet til en lægemiddeladministrationsanordning er et designelement.A method according to any one of the preceding claims, wherein the first or second part (1, 2) of the body of a drug delivery device is a design element. 9. Fremgangsmåde ifølge et af ovennævnte krav, hvor den første eller den anden del (1, 2) af legemet til en lægemiddeladministrationsanordning er en etiket.A method according to any one of the preceding claims, wherein the first or second part (1, 2) of the body of a drug delivery device is a label. 10. Fremgangsmåde ifølge et af ovennævnte krav, hvor den første eller den anden del (1, 2) af legemet til en lægemiddeladministrationsanordning er et transparent dæksel.A method according to any one of the preceding claims, wherein the first or second part (1, 2) of the body of a drug delivery device is a transparent cover. 11. Fremgangsmåde ifølge et af ovennævnte krav, hvor der er anbragt en forsænkning (9) i overfladen af den første del (1) af legemet til en lægemiddeladministrationsanordning, hvor mindst en del af det udvalgte område (5) dækker mindst et udsnit af overfladen af forsænkningen (9).A method according to any one of the preceding claims, wherein a recess (9) is arranged in the surface of the first part (1) of the body for a drug delivery device, wherein at least part of the selected area (5) covers at least one section of the surface. of the recess (9). 12. Fremgangsmåde ifølge et af ovennævnte krav, hvor lægemiddeladministrationsanordningen, der fremstilles, er en sprøjte eller en injektionspen.A method according to any one of the preceding claims, wherein the drug delivery device being manufactured is a syringe or pen. 13. Legeme til en lægemiddeladministrationsanordning, hvor legemet til en lægemiddeladministrationsanordning er fremstillet ved hjælp af fremgangsmåden ifølge et af ovennævnte krav 1 til 12.The body of a drug delivery device, wherein the body of a drug delivery device is manufactured by the method of any one of claims 1 to 12. 14. Legeme til en lægemiddeladministrationsanordning ifølge krav 13, hvor den første eller den anden del (1, 2) af legemet til en lægemiddeladministrationsanordning er et designelement, et transparent dæksel og/eller en etiket.The body of a drug delivery device according to claim 13, wherein the first or second portion (1, 2) of the body of a drug delivery device is a design element, a transparent cover and / or a label.