WO2016124430A1

WO2016124430A1 - Needle unit for piercing a medicament reservoir wall from the inside

Info

Publication number: WO2016124430A1
Application number: PCT/EP2016/051425
Authority: WO
Inventors: Marcus-Meinolf DITTRICH
Original assignee: Sanofi-Aventis Deutschland Gmbh
Priority date: 2015-02-02
Filing date: 2016-01-25
Publication date: 2016-08-11

Abstract

The present disclosure relates to a medicament reservoir (10), comprising a wall (12) defining a cavity for holding a medicament, wherein a needle unit (1) is arranged within the medicament reservoir (10) intended to pierce the wall from an inside to an outside to connect the medicament reservoir (10) to a drug delivery device (16), wherein the wall (12) is flexible at least in an area intended for being pierced by the needle (2) of the needle unit (1). Furthermore, the present disclosure relates to a method for connecting such a medicament reservoir (10) to a drug delivery device (16).

Description

NEEDLE UNIT FOR PIERCING A MEDICAMENT RESERVOIR WALL FROM THE INSIDE

Technical Field

The invention relates to a medicament reservoir and to a method for connecting a drug delivery device to a medicament reservoir.

Background of the present disclosure

Drug delivery devices may be connected to medicament reservoirs which need to be kept sterile prior to use. The connection may be established by piercing a reservoir wall of the reservoir with a hollow needle. A needle interface may be provided to facilitate the connecting process. In particular with a flexible reservoir wall it may be difficult to establish and maintain the connection.

Thus, there remains a need for an improved medicament reservoir and to an improved method for connecting a drug delivery device to a medicament reservoir.

Summary of the present disclosure

It is an object of the present disclosure to provide an improved medicament reservoir and to an improved method for connecting a drug delivery device to a medicament reservoir.

The object is achieved by a medicament reservoir according to claim 1 and by a method according to claim 14.

Exemplary embodiments of the present disclosure are given in the dependent claims.

According to the present disclosure a medicament reservoir comprises a wall defining a cavity for holding a medicament, wherein a needle unit is arranged within the medicament reservoir intended to pierce the wall from an inside to an outside to connect the medicament reservoir to a drug delivery device, wherein the wall is flexible at least in an area intended for being pierced by the needle of the needle unit. The needle unit is arranged within the medicament reservoir such that it cannot be lost or tampered with and such that the wall is piercable by the needle unit from an inside to an outside. Furthermore, this arrangement ensures that the needle unit is replaced every time the

medicament reservoir is replaced.

All the disposables are contained inside the medicament reservoir. An adapter of a delivery device intended to be used with the medicament reservoir may be used multiple times. The delivery device could be designed to contain no sharps on the adapter which would have to be protected against user access.

In an exemplary embodiment, the reservoir comprises a pouch, in which the needle unit is arranged.

In an exemplary embodiment the needle unit for connecting a drug delivery device to the medicament reservoir comprises a hollow needle comprising a sharp tip for piercing the wall of the medicament reservoir, wherein the needle is held in a base element, wherein a needle cover element is arranged over the needle and slidable with respect to the needle in an axial direction, wherein the needle cover element is biased away from the base element towards a needle safe position in which the sharp tip is covered within the needle cover element.

The needle cover element covers the sharp needle tip prior to use and after use.

In an exemplary embodiment the base element is arranged at an end of the needle opposite the sharp tip.

In an exemplary embodiment, the needle comprises a second sharp tip for piercing a wall of a medicament reservoir, wherein a second needle cover element is arranged over the needle and slidable with respect to the needle in the axial direction, wherein the second needle cover element is biased away from the base element towards a needle safe position in which the second sharp tip is covered within the second needle cover element.

A needle unit with two sharp tips allows for a simplified manufacturing of the medicament reservoir as the assembly procedure is independent from an orientation of the needle unit.

In an exemplary embodiment, the needle is held in the base element between the sharp tip and the second sharp tip. In an exemplary embodiment, the base element comprises one or more fluid channels for connecting a lumen of the needle with an outer surface of the base element.

In an exemplary embodiment, one or more springs are arranged to bias the needle cover element away from the base element towards the needle safe position.

In an exemplary embodiment, the needle cover element has a through bore for allowing the needle to pass through.

In an exemplary embodiment, a drug delivery device comprises:

an adapter comprising a membrane or septum,

a nozzle for delivering a medicament, and

a fluid channel for connecting the membrane or septum to the nozzle, wherein the adapter is configured to be placed on the wall of the medicament reservoir with the needle unit such that the sharp tip of the needle pierces through the wall and the membrane or septum.

Building a membrane or septum into the adapter allows for reusing the adapter multiple times. In an exemplary embodiment, the drug delivery device furthermore comprises a pump arranged between the fluid channel and the nozzle for pumping the medicament from the medicament reservoir to the nozzle.

In an exemplary embodiment, the drug delivery device further comprises an energy source for powering the pump.

In an exemplary embodiment, the adapter is separately arranged from and connected to the nozzle and/or pump through the fluid channel. Another aspect of the present disclosure relates to a method for connecting a medicament reservoir to a drug delivery device, the medicament reservoir comprising a wall defining a cavity for holding a medicament, wherein a needle unit is arranged within the medicament reservoir, wherein a flexible area of the wall is pierced by the needle unit from an inside to an outside to connect the medicament reservoir to a drug delivery device.

In an exemplary embodiment, the needle unit comprises a hollow needle comprising a sharp tip for piercing the wall of the medicament reservoir, wherein the needle is held in a base element, wherein a needle cover element is arranged over the needle and slidable with respect to the needle in an axial direction, wherein the needle cover element is biased away from the base element towards a needle safe position in which the sharp tip is covered within the needle cover element, wherein an adapter of the drug delivery device is moved towards the needle unit, thereby contacting the wall and displacing it towards the needle unit such that the wall contacts the needle cover element moving it towards the base element while the needle remains in place, such that the sharp tip of the needle pierces the wall and then a septum within the adapter, establishing a fluid communication between the medicament reservoir and the adapter. Further scope of applicability of the present disclosure will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating exemplary embodiments of the disclosure, are given by way of illustration only, since various changes and modifications within the spirit and scope of the disclosure will become apparent to those skilled in the art from this detailed description.

Brief Description of the Drawings

The present disclosure will become more fully understood from the detailed description given hereinbelow and the accompanying drawings which are given by way of illustration only, and thus, are not limitive of the present disclosure, and wherein:

Figure 1 is a schematic view of an exemplary embodiment of a needle unit prior to use,

Figure 2 is a schematic view of a medicament reservoir with a needle unit,

Figure 3 is a schematic view of the medicament reservoir with a needle unit and an adapter,

Figure 4 is a schematic view of the medicament reservoir with a needle unit and the adapter connected to the medicament reservoir through the needle unit,

Figure 5 is a schematic view of another exemplary embodiment of a needle unit prior to use, and

Figure 6 is a schematic view of the needle unit of figure 5 connected to a drug delivery device with two adapters. Corresponding parts are marked with the same reference symbols in all figures. Detailed Description

Figure 1 is a schematic view of an exemplary embodiment of a needle unit 1 prior to use. The needle unit 1 comprises a hollow needle 2 for establishing a fluid connection between a medicament reservoir and a drug delivery device (not shown). The longitudinal extension of the needle 2 defines an axial direction. The needle 2 comprises a sharp tip 3 intended to pierce a wall of a medicament reservoir. The needle 2 is fixedly held in a base element 4 at an end opposite the sharp tip 3. The base element 4 may comprise one or more fluid channels 5 for connecting a lumen of the needle 2 with an outer surface 6 of the base element 4. A needle cover element 7 having a through bore 8 is arranged over the needle 2 and slidable with respect to the needle 2 in the axial direction. A spring 9 is arranged to bias the needle cover element 7 away from the base element 4 towards a needle safe position in which the sharp tip 3 is covered within the needle cover element 7 as shown in figure 1 .

Figures 2 and 3 are different schematic views of a medicament reservoir 10 with a needle unit 1 as shown in figure 1 . In an exemplary embodiment, the medicament reservoir 10 comprises a pouch 1 1 in which the needle unit 1 is arranged. In an exemplary embodiment, a wall 12 of the medicament reservoir 10 is flexible at least in the area of the pouch 1 1 . In figure 3, an

adapter 13 is shown next to the pouch 1 1 , wherein the sharp tip 3 points towards the adapter 13. The adapter 13 comprises a membrane 14 or septum and a fluid channel 15 configured to connect the membrane 14 to a drug delivery device 16. The adapter 13 may be part of the drug delivery device 16 which may comprise a pump 17 for pumping a medicament from the medicament reservoir 10 to a nozzle 18, e.g. a hypodermic needle. In an exemplary

embodiment, an energy source 19, e.g. a battery or a spring may be provided for powering the pump 17. In an alternative exemplary embodiment, the adapter 13 may be a separate unit connectable to a drug delivery device 16 through the fluid channel 15.

Figure 4 is a schematic view of the medicament reservoir 10 with the needle unit 1 and the adapter 13, wherein the adapter 13 is connected to the medicament reservoir 10 through the needle unit 1 . Starting from the position shown in figure 3, the adapter 13 has been moved towards the needle unit 1 , thereby contacting the wall 12 of the pouch 1 1 and displacing it towards the needle unit 1. During this movement, the wall 12 has in turn contacted the needle cover element 7 moving it towards the base element 4 against the bias of the spring 9 while the needle 2 has remained in place. As soon as the cover element 7 has been sufficiently moved to expose the sharp tip 3 of the needle 2, the sharp tip 3 pierces the wall 12 and then the septum within the adapter 13, establishing a fluid communication between the medicament reservoir 10 and the fluid channel 15 of the adapter 13 through the fluid channels 5 in the base element 4 and the needle 2.

Figure 5 is a schematic view of another exemplary embodiment of a needle unit 1 prior to use. The needle unit 1 comprises a hollow needle 2 for establishing a fluid connection between a medicament reservoir 10 and a drug delivery device (not shown). The longitudinal extension of the needle 2 defines an axial direction. The needle 2 comprises a first sharp tip 3.1 and a second sharp tip 3.2 intended to pierce a wall 12 of a medicament reservoir 10. The needle 2 is fixedly held in a base element 4 between the first and second sharp tips 3.1 , 3.2. The base element 4 may comprise one or more fluid channels 5 for connecting a lumen of the needle 2 with an outer surface 6 of the base element 4. A first needle cover element 7.1 having a through bore 8 is arranged over the needle 2 and slidable with respect to the needle 2 in the axial direction. A first spring 9.1 is arranged to bias the first needle cover element 7.1 away from the base element 4 towards a needle safe position in which the first sharp tip 3.1 is covered within the first needle cover element 7.1 as shown in figure 5. A second needle cover element 7.2 having a through bore 8 is arranged over the needle 2 and slidable with respect to the needle 2 in the axial direction. A second spring 9.2 is arranged to bias the second needle cover element 7.2 away from the base element 4, i.e. also away from the first needle cover element 7.1 , towards a needle safe position in which the second sharp tip 3.2 is covered within the second needle cover element 7.2 as shown in figure 5.

The advantage of this embodiment is that the needle unit 1 can be inserted into the reservoir 10 in both directions regardless where the top or bottom surface of the reservoir 10 is. This would make production lines simpler, hence, less expensive because the needle units 1 do not have to be brought into a specific orientation (top/bottom) before they are inserted into the reservoir 10. In Fig.4 it is shown that the sharp tip 3 penetrates a portion of the reservoir wall 12 that can be referred to as the upper wall because of its orientation. On the other hand, the base element 4 is pressed against the bottom wall of the reservoir 10. If the needle unit 1 in figure 4 would have been inserted upside down, the sharp tip 3 would penetrate the bottom wall without establishing a connection to the drug delivery device 16. For the embodiment with the two sharp tips 3.1 , 3.2 shown in figure 5, the delivery device could comprise two adapters 13 that are arranged on opposite sides to clamp the needle unit 1 in between. That way, the reservoir 10 would not have to have a dedicated upper wall and a bottom wall. Figure 6 shows the needle unit 1 of figure 5 connected to a drug delivery device with two adapters 13.

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, an enzyme, an antibody or a fragment thereof, 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 exendin-3 or exendin-4 or an analogue or derivative of exendin-3 or exendin-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, 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.

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-(oo-carboxyheptadecanoyl)-des(B30) human insulin and Β29-Ν-(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-Gln-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.

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 Exendin-4(1-39),

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(02)25, Asp28] Exendin-4(1-39),

des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1-39),

des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1-39),

des Pro36 [Met(0)14 Trp(02)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(02)25, Asp28] Exendin-4(1-39),

des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1-39),

des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1-39),

des Pro36 [Met(0)14 Trp(02)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

des Pro36 Exendin-4(1-39)-Lys6-NH2 (AVE0010),

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(02)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Trp(02)25] Exendin-4(1 -39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-NH2,

des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Met(0)14, Asp28] Exendin-4(1-39)-Lys6-NH2,

des Met(0)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,

H-(Lys)6-desPro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Met(0)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(02)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Met(0)14, Trp(02)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(02)25, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(S1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6- NH2; or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exendin-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, Triptorelin, 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 enoxaparin sodium.

Antibodies are globular plasma proteins (-150 kDa) that are also known as immunoglobulins which share a basic structure. As they have sugar chains added to amino acid residues, they are glycoproteins. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA, tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like mammalian IgM.

The Ig monomer is a "Y"-shaped molecule that consists of four polypeptide chains; two identical heavy chains and two identical light chains connected by disulfide bonds between cysteine residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. Heavy and light chains each contain intrachain disulfide bonds which stabilize their folding. Each chain is composed of structural domains called Ig domains. These domains contain about 70-1 10 amino acids and are classified into different categories (for example, variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two β sheets create a "sandwich" shape, held together by interactions between conserved cysteines and other charged amino acids.

There are five types of mammalian Ig heavy chain denoted by α, δ, ε, γ, and μ. The type of heavy chain present defines the isotype of antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively. Distinct heavy chains differ in size and composition; a and γ contain approximately 450 amino acids and δ approximately 500 amino acids, while μ and ε have approximately 550 amino acids. Each heavy chain has two regions, the constant region (C_H) and the variable region (V_H). In one species, the constant region is essentially identical in all antibodies of the same isotype, but differs in antibodies of different isotypes. Heavy chains γ, a and δ have a constant region composed of three tandem Ig domains, and a hinge region for added flexibility; heavy chains μ and ε have a constant region composed of four immunoglobulin domains. The variable region of the heavy chain differs in 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 1 10 amino acids long and is composed of a single Ig domain.

In mammals, there are two types of immunoglobulin light chain denoted by λ and κ. A light chain has two successive domains: one constant domain (CL) and one variable domain (VL). The approximate length of a light chain is 21 1 to 217 amino acids. Each antibody contains two light chains that are always identical; only one type of light chain, κ or λ, is present per antibody in mammals. Although the general structure of all antibodies is very similar, the unique property of a given antibody is determined by the variable (V) regions, as detailed above. More specifically, variable loops, three each the light (VL) and three on the heavy (VH) chain, are responsible for binding to the antigen, i.e. for its antigen specificity. These loops are referred to as the Complementarity Determining Regions (CDRs). Because CDRs from both VH and VL domains contribute to the antigen-binding site, it is the combination of the heavy and the light chains, and not either alone, that determines the final antigen specificity.

An "antibody fragment" contains at least one antigen binding fragment as defined above, and exhibits essentially the same function and specificity as the complete antibody of which the fragment is derived from. Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino terminal fragments, each containing one entire L chain and about half an H chain, are the antigen binding fragments (Fab). The third fragment, similar in size but containing the carboxyl terminal half of both heavy chains with their interchain disulfide bond, is the crystalizable fragment (Fc). The Fc contains carbohydrates, complement- binding, and FcR-binding sites. Limited pepsin digestion yields a single F(ab')2 fragment containing both Fab pieces and the hinge region, including the H-H interchain disulfide bond. F(ab')2 is divalent for antigen binding. The disulfide bond of F(ab')2 may be cleaved in order to obtain Fab'. Moreover, the variable regions of the heavy and light chains can be fused together to form a single chain variable fragment (scFv).

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. Those of skill in the art will understand that modifications (additions and/or removals) of various components of the apparatuses, methods and/or systems and embodiments described herein may be made without departing from the full scope and spirit of the present disclosure, which encompass such modifications and any and all equivalents thereof.

List of References

1 needle unit

2 needle

3 sharp tip

3.1 first sharp tip

3.2 second sharp tip

4 base element

5 fluid channel

6 outer surface

7 needle cover element

7.1 first needle cover element

7.2 second needle cover element

8 through bore

9 spring

9.1 first spring

9.2 second spring

10 medicament reservoir

1 1 pouch

12 wall

13 adapter

14 membrane

15 fluid channel

16 drug delivery device

17 pump

18 nozzle

19 energy source

Claims

1. Medicament reservoir (10), comprising a wall (12) defining a cavity for holding a medicament, wherein a needle unit (1 ) is arranged within the medicament reservoir (10) intended to pierce the wall from an inside to an outside to connect the medicament reservoir (10) to a drug delivery device (16), wherein the wall (12) is flexible at least in an area intended for being pierced by the needle (2) of the needle unit (1 ).

2. Medicament reservoir (10) according to claim 1 , wherein the reservoir (10) comprises a pouch (1 1 ), in which the needle unit (1 ) is arranged.

3. Medicament reservoir (10) according to claim 1 or 2, wherein the needle unit (1 ) comprises a hollow needle (2) comprising a sharp tip (3, 3.1 ) for piercing the wall (12) of the medicament reservoir (10), wherein the needle (2) is held in a base element (4), wherein a needle cover element (7, 7.1 ) is arranged over the needle (2) and slidable with respect to the needle (2) in an axial direction, wherein the needle cover element (7, 7.1 ) is biased away from the base element (4) towards a needle safe position in which the sharp tip (3, 3.1 ) is covered within the needle cover element (7, 7.1 ).

4. Medicament reservoir (10) according to claim 3, wherein the base element (4) is arranged at an end of the needle (2) opposite the sharp tip (3, 3.1 ).

5. Medicament reservoir (10) according to claim 3, wherein the needle (2) comprises a second sharp tip (3.2) for piercing a wall (12) of a medicament reservoir (10), wherein a second needle cover element (7.2) is arranged over the needle (2) and slidable with respect to the needle (2) in the axial direction, wherein the second needle cover element (7.2) is biased away from the base element (4) towards a needle safe position in which the second sharp tip (3.2) is covered within the second needle cover element (7.2).

6. Medicament reservoir (10) according to claim 5, wherein the needle (2) is held in the base element (4) between the sharp tip (3.1 ) and the second sharp tip (3.2).

7. Medicament reservoir (10) according to any one of the claims 3 to 6, wherein the base element (4) comprises one or more fluid channels (5) for connecting a lumen of the needle (2) with an outer surface (6) of the base element (4).

8. Medicament reservoir (10) according to any one of the claims 3 to 7, wherein one or more springs (9, 9.1 , 9.2) are arranged to bias the needle cover element (7, 7.1 , 7.2) away from the base element (4) towards the needle safe position.

9. Medicament reservoir (10) according to any one of the claims 3 to 8, wherein the needle cover element (7, 7.1 , 7.2) has a through bore (8) for allowing the needle (2) to pass through.

10. Drug delivery device (16) comprising:

an adapter (13) comprising a membrane (14) or septum,

a nozzle (18) for delivering a medicament, and

- a fluid channel (15) for connecting the membrane (14) or septum to the nozzle (18), wherein the adapter (13) is configured to be placed on the wall (12) of a medicament reservoir (10) according to any one of the preceding claims such that the sharp tip (3, 3.1 , 3.2) of the needle (2) pierces through the wall (12) and the membrane (14) or septum.

1 1. Drug delivery device (16) according to claim 10, furthermore comprising a pump (17) arranged between the fluid channel (15) and the nozzle (18) for pumping the medicament from the medicament reservoir (10) to the nozzle (18).

12. Drug delivery device (16) according to claim 1 1 , further comprising an energy source (19) for powering the pump (17).

13. Drug delivery device (16) according to any one of the claims 10 to 12, wherein the adapter (13) is separately arranged from and connected to the nozzle (18) and/or pump (17) through the fluid channel (15).

14. Method for connecting a medicament reservoir (10) to a drug delivery device (16), the medicament reservoir (10) comprising a wall (12) defining a cavity for holding a medicament, wherein a needle unit (1 ) is arranged within the medicament reservoir (10), wherein a flexible area of the wall (12) is pierced by the needle unit (1 ) from an inside to an outside to connect the medicament reservoir (10) to a drug delivery device (16).

15. Method according to claim 14, wherein the needle unit (1 ) comprises a hollow needle (2) comprising a sharp tip (3, 3.1 ) for piercing the wall (12) of the medicament reservoir (10), wherein the needle (2) is held in a base element (4), wherein a needle cover element (7, 7.1 ) is arranged over the needle (2) and slidable with respect to the needle (2) in an axial direction, wherein the needle cover element (7, 7.1 ) is biased away from the base element (4) towards a needle safe position in which the sharp tip (3, 3.1 ) is covered within the needle cover element (7, 7.1 ), wherein an adapter (13) of the drug delivery device (16) is moved towards the needle unit (1 ), thereby contacting the wall (12) and displacing it towards the needle unit (1 ) such that the wall (12) contacts the needle cover element (7, 7.1 ) moving it towards the base element (4) while the needle (2) remains in place, such that the sharp tip (3) of the needle (2) pierces the wall (12) and then a septum within the adapter (13), establishing a fluid communication between the medicament reservoir (10) and the adapter (13).