Login| Sign Up| Help| Contact|

Patent Searching and Data


Title:
SECONDARY PACKAGING ARRANGEMENT FOR A MEDICAMENT
Document Type and Number:
WIPO Patent Application WO/2013/050342
Kind Code:
A1
Abstract:
The present invention relates to a packaging arrangement comprising: at least one boundary wall (34, 35, 36, 37,38) confining an inner volume (32) to receive at least one item (24), at least one fastening member (40; 44; 50; 60; 70) engageable with the at least one boundary wall (34, 35, 36, 37, 38) and with a predefined shelf structure (18, 20) to attach the packaging arrangement in a hanging configuration to the shelf structure (18, 20).

Inventors:
MICHEL MAXIMILIAN (DE)
Application Number:
PCT/EP2012/069405
Publication Date:
April 11, 2013
Filing Date:
October 02, 2012
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
SANOFI AVENTIS DEUTSCHLAND (DE)
International Classes:
B65D5/42; A61J1/00; B65D25/22
Domestic Patent References:
WO1997026811A11997-07-31
Foreign References:
US2920757A1960-01-12
US4928849A1990-05-29
Other References:
"Rote Liste", 2008
"Remington's Pharmaceutical Sciences", 1985, MARK PUBLISHING COMPANY
Download PDF:
Claims:
Claims

1 . A packag ing arrangement comprising : - at least one boundary wall (34, 35, 36, 37 ,38) confining an inner volume (32) adapted to receive at least one item (24), at least one fastening member (40; 44; 50; 60; 70) engageable with the at least one boundary wall (34, 35, 36, 37, 38) and with a predefined shelf structure (1 8, 20) to attach the packaging arrangement in a hanging configuration to the shelf structure (1 8, 20).

2. The packaging arrangement according claim 1 , wherein the fastening

member (40; 44; 50; 70) is adapted to positively engage the at least one boundary wall (34, 35, 36, 37, 38) with the shelf structure (1 8, 20).

3. The packaging arrangement according to any one of the preceding claims, wherein the fastening member (60) is adapted to provide a holding force to keep the boundary wall (34) in a predefined attachment position relative to the shelf structure (1 8, 20).

4. The packag ing arrangement accord ing to any one of the preceding claims, wherein the fastening member (40; 44; 50; 60) is at least partially integrated into the at least one boundary wall (34) and/or wherein the fastening member (40; 44; 50) is integrally formed with the at least one boundary wall

(34).

5. The packaging arrangement according to claim 4, wherein the fastening member (40; 44; 50) comprises an appendix of at least one boundary wall (42) which is foldable and/or bendable into an attachment configuration.

6. The packag ing arrangement accord ing to any one of the preceding claims, wherein the at least one fastening member (40; 44; 50; 60) is adapted to extend or to act through the plane of the shelf structure (1 8, 20).

7. The packag ing arrangement according to any one of the preceding claims, wherein the fastening member (40; 44) comprises at least one hook-shaped structure (40; 44) adapted to penetrate a corresponding opening (43) of the shelf-structure (1 8, 20) in a squeezed or folded configuration .

8. The packaging arrangement according to any one of the preceding claims,

wherein at least one fastening member (40; 44) levels with an upper surface (39) of an upper boundary wall (34) in an initial configuration and wherein the fastening member (40; 44) is foldable and/or bendable into an attachment configuration in which the fastening member (40; 44) protrudes from said surface (39). 9. The packag ing arrangement according to any one of the preceding claims, wherein the fastening member (50; 60) comprises at least one pair of mutually attracting magnetic elements (62, 64, 66, 68) to be arranged on opposite sides of the shelf structure (20). 1 0. The packaging arrangement according to claim 9, wherein a first magnetic (66, 68) element is arranged on or is integrated in the shelf structure (20) and wherein a second magnetic or ferromagnetic element (62, 64) is attached to the boundary wall (34) or is arranged inside the inner volume (32).

1 1 . The packag ing arrangement according to any one of the preceding claims, wherein the fastening member (70) comprises a C- or U-shaped clip having a lower branch (74) and an upper branch (72), wherein the lower branch (74) is adapted to be introduced into the inner volume (32) adjacent an upper boundary wall (34) and wherein the upper branch (72) is adapted to be arranged on an upper side of the shelf structure (20).

1 2. The packaging arrangement according to any one of the preceding claims comprising a foldable lid (50) to act as a fastening member by unfold ing at least two segments (52, 54, 56) thereof into a clamp-like configuration . 1 3. The packaging arrangement according to claim 1 , wherein the at least one or several boundary walls comprise cardboard panels or plastic panels.

14. The packaging arrangement according to any one of the preceding claims providing a secondary packaging for a medicament and having at least one medicament provided in a primary packing (24) disposed therein .

1 5. A storage assembly comprising : packaging arrangement (30) according to any one of the preceding

at least one shelf-structure (1 8, 20) adapted to engage with the at least one fastening member (40; 44; 50; 60; 70) of the packaging

arrangement (30) in order to attach the packaging arrangement in a hanging configuration .

Description:
Secondary Packaging Arrangement for a Medicannent

Description Field of the Invention

The present invention relates to the field of packaging and in particular to

secondary packaging for medicaments that require refrigerated storage. Background

Patients suffering chronic disease require regular treatment with medicaments, e.g. on the basis of a predefined schedule. Particular medicaments require refrigerated storage and therefore have to be stored refrigerated, e.g. in a household fridge. Especially in a home treatment environment, the patient himself has to store the medicament and to administer a predefined dose thereof. Hence, the medicament is typically provided in a secondary packaging and is conveniently put and stored in the household fridge together with other items that require constant refrigeration, such like foodstuffs.

Depending on the dosage form of the medicament, the secondary packaging containing the medicament may not only provide a package for primary packed medicament itself but also for different kinds of drug delivery devices, e.g. by way of which the respective medicament is to be administered. For instance, the respective medicament may be provided in a pre-filled syringe or in a pen-type injector, which require comparatively large storage space in the refrigerated storage environment.

For a patient it may be therefore quite cumbersome to keep the refrigerated area tidy and cleaned up, such that the particular medicament provided in the secondary packaging can be easily and clearly distinguished from other items, such like foodstuffs or beverages kept in the refrigerated environment. Moreover, rather spacious dosage forms and secondary packagings for medicaments contravene a practical partitioning of a refrigerated area or volume, e.g. inside a household fridge. Objects of the Invention

It is therefore an object of the present invention to provide an improved packaging arrangement for medicaments, which is optimized for keeping and storing the packaging in a refrigerated area. It is a further object, to optimize spatial

partitioning of a fridge and to improve the structure and the clarity of items kept in a refrigerated area.

Summary of the Invention In a first aspect, the invention relates to a packaging arrangement comprising at least one boundary wall that confines an inner volume of the package, which is adapted to receive at least one item. In a further embodiment, the packaging arrangement comprises several boundary walls forming an essentially closed inner volume to store multiple items therein.

The packaging arrangement further comprises at least one fastening member engageable with the at least one boundary wall and being further engageable with a predefined shelf structure. The fastening member can therefore act as an attachment means to attach and to fix the packaging arrangement in an attached configuration, preferably a hanging configuration to the shelf structure. The fastening member is designed and formed in such a way, that the packaging arrangement and its at least one boundary wall supporting or holding the at least one item can be placed and kept in an attached or a hanging configuration inside the refrigerated area. In particular, the packaging arrangement can be attached to a lower side or underside of a shelf structure as it is typically present or provided in a household fridge. This way, floor space onto which various items can be arranged inside the fridge is no longer required for storage of the packaging arrangement. This way, storage space on top of a shelf structure can be vacated and can be used otherwise.

Moreover, a hanging packing arrangement may remain clearly visible and distinguishable from other items standing on the floor space. Hence, overall structuring and clarity of the arrangement of items kept in a refrigerated area can be improved by the hanging packing arrangement.

Also, a risk can be reduced that the medicament and/or its packaging may get lost among other items kept in the refrigerated area. By providing the packaging arrangement with a fastening member to hang the packaging arrangement onto or below a shelf of the fridge, the packaging and the medicament itself can be retrieved more easily since the packaging itself defines a particular storage position and configuration relative to a shelf structure of e.g. a household fridge. According to a preferred embodiment, the fastening member is adapted to positively engage the at least one boundary wall with the shelf structure. In effect, by way of the fastening member, the packaging arrangement, at least its boundary wall, may positively engage and may be fastened to the shelf structure thereby establishing a positive interconnection. By means of the positive interconnection, removal and replacement of the packaging arrangement can be easily conducted.

Moreover, a positive interlock or interconnection is rather insensitive in terms of temperature and/or humidity. In a further approach, the fastening member and/or the at least one boundary wall is or are adapted to be clipped to the shelf structure preferably in such a way, that the inner volume defined by the at least one boundary wall of the secondary packaging is located below the shelf structure. In another embodiment, the fastening member is adapted to provide or to generate a holding force to keep the at least one boundary wall in a predefined attachment position relative to the shelf structure. The holding force may either be of adhesive or magnetic type, thereby providing a force-fitting interconnection of the at least one boundary wall and the shelf structure.

According to another embodiment, the fastening member is at least partially integrated into the at least one boundary wall. Additionally or alternatively, the at least one fastening member is integrally formed with the at least one boundary wall. Depending on the type of fastening member, it may either be provided on the surface of the boundary wall or may even be embedded in the bulk of the boundary wall. The fastening member may further be activated, e.g. by folding or bending into a fastening configuration, in which the fastening member can for instance positively engage with the shelf structure.

When the fastening member is entirely embedded in a boundary wall, it may for instance comprise one or several magnetic elements, by way of which e.g. a foldable portion of the boundary wall adapted to at least partially embrace a front edge of the shelf structure can be kept in position .

According to a further embodiment, the fastening member may also comprise an appendix of at least one boundary wall of the package which is foldable or bendable into an attachment configuration. Once transferred to the attachment configuration, the fastening member may protrude from the boundary wall in order to engage with the shelf structure.

In still another embodiment, the at least one fastening member is further adapted to extend and/or to act through the plane of the shelf structure. Hence, the fastening member may physically extend through e.g. an orifice or an opening of the shelf structure or a grid or may act in any other way perpendicular to the plane of the shelf structure. For instance, by arranging mutually corresponding and interacting magnetic elements on different sides of the self structure, a holding magnetic force may act therethrough.

A fastening member may for instance further comprise at least one hook-shaped structure which is adapted to penetrate a corresponding opening of the shelf structure, preferably in a squeezed or folded configuration. As soon as the hook- shaped structure extends through such a opening, it may laterally expand or unfold in such a way, that it provides a positive interlock with the shelf structure in the circumference of its opening. This embodiment is of particular benefit when the shelf structure comprises one or several openings. Especially for household fridges, a shelf may comprise a grid-like structure featuring a plurality of slats or rods extending parallel with respect to each other and being arranged at a distance from each other, such that hook-shaped fastening members may extend

therebetween.

In a further embodiment, the at least one fastening member levels with the upper surface of an upper boundary wall in an initial configuration, thereby forming a substantially planar surface. The fastening member may further be folded or bended into an attachment configuration, in which the fastening member protrudes and extends from said surface when mounted in the fridge. The upper surface of the upper boundary wall typically faces towards a lower side of the shelf structure. The unfolded or bended fastening member may then protrude through the shelf structure from underneath. By having the fastening member in a substantially planar position with the boundary wall, the fastening member only has a minimum influence on the outer appearance of the packaging arrangement. Furthermore, the fastening member may remain entirely inactive while distributed among pharmaceutical wholesale and pharmacy retail . By not protruding or extending from the boundary walls of the packaging arrangement when in initial configuration, the fastening member is also effectively protected against damage during transportation across the various sale and retail stages. Moreover, the patient himself may individually decide whether he wants to make use of the fastening member. If a hanging storage is neither required nor wanted by the user, the fastening member may remain inactive and may neither disturb nor influence other ways to store and to arrange the packaging arrangement.

According to another embodiment, the fastening member comprises at least one pair of mutually attracting magnetic elements to be arranged on opposite sides of the shelf structure, wherein the term "mutually attracting magnetic elements" means either a first magnetic element and a second magnetic element or a magnetic element and a ferromagnetic. A magnetic element may be embedded in the at least one boundary wall or may elsewhere be disposed in the inner volume of the packaging. By way of additional magnetic elements to be positioned on top of the shelf structure, magnetic attraction of mutually corresponding pairs of magnetic elements arranged above and below the shelf structure can be

established, thereby squeezing and fixing the at least one boundary wall and the package to a lower side of the shelf structure.

The holding force provided by the magnetic elements should be at least large enough to hold the packaging arrangement in an attached, e.g. a hanging configuration at the bottom or underside of the shelf structure.

In further embodiments, the packaging arrangement may comprise an appendix to be folded around an edge portion of the shelf structure, such that the shelf structure is at least partially embraced by said appendix or flap. It is then of particular benefit, when the at least one boundary wall and the appendix are provided with mutually corresponding or mutually attracting magnetic elements being arranged in a substantially overlapping manner in the plane of the shelf structure. Apart from that and according to another embodiment, a first magnetic element may be arranged on or in the shelf structure while a second magnetic or

ferromagnetic element is either attached to the boundary wall, is embedded in the boundary wall or is arranged inside the inner volume confined by the boundary wall. According to another embodiment, a first ferromagnetic element may be arranged on or in the shelf structure while a second magnetic element is either attached to the boundary wall, is embedded in the boundary wall or is arranged inside the inner volume confined by the boundary wall. When bringing the

packaging arrangement in close proximity to the shelf a magnetic attraction force builds up and fixes the packaging arrangement in an attached or hanging

configuration to the shelf structure.

According to a further embodiment, the fastening member may comprise a C- or U- shaped clip having a lower branch and an upper branch by way of which the packaging arrangement can be attached to the bottom or to the underside of the shelf structure. In particular, the lower branch of the clip is adapted to be

introduced into the inner volume adjacent an upper boundary wall and the upper branch of the clip is adapted to be arranged on an upper side of the shelf structure. Upper and lower branch may be elastically deformable against a reset or restoring force, by way of which a clamping effect perpendicular to the plane of the shelf structure can be attained in general .

This way, the clip may also provide a kind of frictional engagement of clip, shelf structure and boundary wall. The lower branch of the clip is typically inserted into the inner volume of the package in such way, that the free end of the lower branch points towards an opposite side wall of the package. In effect, lower and upper branch of the clip embrace and/or frictionally engage with the at least one boundary wall and the shelf structure of the fridge.

In still another embodiment, the packaging arrangement comprises a foldable lid to act as a fastening member by unfolding at least two segments of the lid into a clamp-like configuration. The lid may serve as a closure member to provide access to the inner volume by way of unfolding the lid . The lid may comprise various segments to be folded with respect to numerous pivot or folding axis extending substantially parallel with respect to each other. For instance, by folding the lid and/or its segments by 90° or 180° with respect to each other, the unfolded lid may extend substantially parallel to the boundary wall at a distance therefrom in order to receive an upper edge of the shelf structure therebetween. The lid may be equipped with a magnetic fastening element substantially

overlapping with a magnetic element of the upper boundary wall when it reaches its unfolded configuration. Alternatively, it is even conceivable, that the foldable lid is stiffened or structurally enhanced in such a way, that the unfolded lid provides a sufficient holding force to keep the packaging arrangement in a hanging

configuration at the underside of the shelf structure.

In a further embodiment, the upper boundary wall of the secondary packaging arrangement may be attached to the shelf by means of an adhesive, whereby the packaging arrangement is attached to the shelve in a hanging position. In still a further embodiment, the at least one or several boundary walls forming a secondary packaging comprise cardboard panels or plastic panels. It is of particular benefit, when the boundary walls and/or the secondary packaging are made of a lightweight and convenient material, which is easy to discard and/or to recycle after use. It is also advantageous, when the packaging is manufactured from a single material blank featuring numerous fold lines to assemble the packaging in a cost-efficient and convenient way.

According to a further embodiment, the packaging arrangement provides and serves as a secondary packaging for a medicament and having at least one medicament provided in a primary packaging disposed therein. Moreover, the secondary packaging may provide storage of several drug delivery devices such as pre-filled syringes, pen-type injectors or other dosage forms like carpules, ampoules or vials that contain a predefined amount of e.g. a liquid medicament and which are to be used as replaceable supply items with a corresponding drug delivery device. In still another but independent aspect the invention also refers to a storage assembly comprising at least one packaging arrangement as described above and at least one shelf structure that mates with the at least one fastening member of the packaging assembly. The self structure may be equipped with one or several fastening elements or fastening members to provide releasable attachment of the packaging arrangement thereto.

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; Β29-Ν-(ω- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-( -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-G lu-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(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

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(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(O)14, Asp28] Exendin-4(1 -39)-(Lys)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)-(Lys)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 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 glucosanninoglycane, 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 (CH) 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, K 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.

It will be further apparent to those skilled in the pertinent art that various

modifications and variations can be made to the present invention without departing from the spirit and scope of the invention. Further, it is to be noted, that any reference signs used in the appended claims are not to be construed as limiting the scope of the present invention. Brief Description of the Drawings

In the following, preferred embodiments of the invention will be described by making reference to the drawings, in which: Figure 1 schematically illustrates the inner volume of a household fridge, illustrates a packaging arrangement in a hanging configuration on a grid-like fridge shell from a side view; Figure 3 shows the embodiment according to Figure 2 in a front view, shows another embodiment featuring rhombus-like fastening members, schematically shows a hanging configuration of a packaging arrangement with a foldable lid in a side view, shows the embodiment according to Figure 5 with a partially unfolded lid , is illustrative of a magnetic attachment of the packaging arrangement and illustrates an attachment of the packaging arrangement to the shelf by means of a fastening clip.

Detailed Description

Figure 1 schematically illustrates a refrigerated area as it is typically present in a household fridge 1 0. The fridge 1 0 comprises two shelf structures 1 8, 20 dividing the inner volume of the fridge 1 0 into free compartments 1 2, 14, 1 6. Any of the compartments 1 2, 14, 1 6 and shelves 1 8, 20 provide floor space to put and to store items 22 like foodstuffs thereon .

Figure 1 is further indicative of two packaging arrangements 30 having four items 24 stored therein . The packaging arrangements 30 are designed as secondary packaging for medicaments in different dosage forms 24. As illustrated for instance in Figures 2, 5 to 8, the dosage form 24 may comprise a sleeve-like barrel provided with a seal 26 at one end thereof. Such barrels, may be used as cartridges for pen- type injectors or may serve as a pre-filled syringe. Typically, such items 24 comprise a vitreous body, e.g . made of transparent or opaque glass or a plastic, being at least partially filled with a liquid medicament that requires refrigerated storage. The secondary packaging 30 as for instance illustrated in Figures 2 and 3 comprises an upper boundary wall 34, a bottom wall 38 and at least three side walls 35, 36 and 37. Opposite the side wall 36 as illustrated in Figure 2, there is provided an unloading opening 80 through which the items 24 are individually accessible to be taken out of the secondary packaging 30, even without moving the packaging itself. The packaging 30 is particularly adapted for storage in the refrigerated area 1 0 by way of hanging to a shelf 1 8, 20.

The well defined hanging storage of the packaging in which the items 42 are arranged substantially horizontal , further allows to remove a side wall and to freely and/or to permanently expose the inner volume 32 of the packaging 30 to the user.

This way, the fill ing level of the packaging is permanently visible and a risk that the stock of items 24 is running low or even running out can be reduced . Also, various storage items 24 may partially extend from the inner volume 32 confined by the boundary walls 34, 36, 36, 37, 38 and may extend across the unloading opening

80. This may provide easier gripping of individual items 24 while the packaging remains in place at the shelf 1 8.

The embodiments according to Figures 2, 3 and 4 therefore comprise at least two, preferably at least four regularly arranged fastening members 40 protruding upwardly from the upper boundary wall 34, thereby extending through a perforated structure of the shelf 1 8. In this configuration, the shelf 1 8 comprises several parallel extending slats or rods 42 spaced at a distance from each other in e.g . x- direction . The hook-shaped fastening members 40 may be forced through the open space 43 between the slats 42 until a configuration as indicated in Figure 3 is attained, in which laterally extending bevelled hooked portions of the fastening members 40 extend above the shelf 1 8 as seen in y-direction .

The hook-shaped structures 40 may be elastically deformable or foldable in order to pass through the openings 43 formed between the parallel and equidistantly arranged slats 42. The lateral size of the though opening 43 is smaller than a lateral extension of the relaxed or unfolded hook-shaped structures 40. The embodiment according to Figure 4 sl ightly deviates from the one illustrated in Figures 2 and 3 in that instead of hook-shaped fastening members 40 rhombus-l ike fastening members 44 are used . The rhombus-like structures 44 are preferably foldable or bendable with respect to a fold line 48 extending in y-direction, thereby allowing that the lateral extension of the fastening members 44 can be reduced in order to pass through the openings 43 between the equidistantly arranged slats 42. For this purpose the fastening members 44 comprise two foldable flaps 46 bendable with respect to the fold line 48 and being attached to the boundary wall 34 via a socket 47.

Moreover, it is conceivable that the fastening members 44 are twisted with respect to the socket 47 or with respect to an axis 48 extending substantially in y-direction, hence parallel to the surface normal of the upper surface 39 of the upper boundary wall 34.

The hook-shaped as well as the rhombus-l ike implementation of fastening

members 40, 44 is intuitive and rather easy to use. Moreover, the fastening members 40, 44 may be initially leveled with the upper surface 39 of the upper boundary wall 34 and may be unfolded or bended into the illustrated attachment configuration on demand, prior to a hanging storage of the packaging arrangement inside a household fridge 1 0.

The fastening members 40, 44 can be made from the same material as the boundary walls 34, 35, 36, 37, 38. The upper surface 39 of the upper boundary wall 34 may be further provided with a visible mark or with a perforation indicating, where the fastening members 40, 44 are located and how they can be folded or bended into the shown attachment configuration .

The embodiment according to Figures 5 and 6 is particularly adapted to attach a packaging arrangement to a shelf structure 20 that features no or non-appropriate openings and which may for instance be made of glass. In this embodiment, the fastening member 50 comprises a foldable lid having three segments 52, 54, 56, each of which being pivotable with respect to adjacent or neighbouring segments 52, 54, 56 along a pivot axis extending substantially in x-direction . As illustrated by the arrow in Figure 6, the base segment 52 of the lid may be folded about 90° until it substantially protrudes perpendicular and upwardly from the upper boundary wall 34 of the packaging arrangement 30.

Then, an adjacent middle lid portion 54 or mid segment can be pivoted by about 1 80° relative to the base segment 52 in order to become substantially parallel arranged and oriented with respect to the upper boundary wall 34. In a similar way also the subsequent lid segment 56 forming a free end of the l id can be pivoted by 90° relative to the mid segment 54 until both lid segments 54, 56 co-al ign on the upper side of the shelf 20 as illustrated in Figure 5. Add itionally, the upper boundary wall 34 of the packaging 30 as well as the free end of the foldable l id 56, 50 can be provided with mutually attracting magnetic elements 62, 66, which in the attachment configuration according to Figure 5 may substantially overlap in the vertical direction (y).

Since the magnetic elements 62, 66 mutually attract each other, the unfolded l id 50 partially embracing a left-side located edge of the shelf 20 serves as a cl ip and provides a kind of clamping force keeping the packaging arrangement 30 in position at the bottom or underside of the shelf 20.

Figure 7 further illustrates another embodiment, wherein the packaging

arrangement 30 comprises two magnetic elements 62, 64 embedded in the bul k of the upper boundary wall 34. The magnetic elements 62, 64 of the upper boundary wall 34 substantially overlap with mutually corresponding magnetic elements 66, 68 located on the opposite or upper side of the shelf 20 that faces away from the packaging arrangement 30. Since magnetic elements 62, 66 and magnetic elements 64, 68 mutually attract each other, a respective holding force can be provided by way of which, the packaging arrangement 30 can be kept in a hanging position underneath the shelf 20. According to alternative but not illustrated embodiments, the magnetic elements 66, 68 can also be embedded in the bul k of the shelf 20. Additionally or

alternatively, the magnetic elements 66, 68 can for instance be adhesively attached at a lower or upper side of the shelf 20. Also, the magnetic elements 62, 64 of the packaging arrangement 30 can be either fastened inside or outside the boundary wall 34 as long as mutually overlapping and mutually corresponding magnetic elements 62, 66 and 64, 68 provide sufficient magnetic attraction .

Figure 8 is further illustrative of another embodiment, wherein the fastening member comprises a clip 70 having an upper branch 72 and a lower branch 74 interconnected by a middle section 76. Branches 72 and 74 are adapted to receive both the upper boundary wall 74 of the packaging arrangement 30 as well as an edge portion of the shelf structure 20 located therebetween . The cl ip 70 and its branches 72, 74 may be elastically deformable and may - depending on an eventual preload - also provide a substantial friction force between branches 72, 74, shelf 20 and upper boundary wall 34.

As further illustrated in Figure 8, the clip 70 is adapted and intended to be inserted with its lower branch 74 into an unloading opening 80 of the packaging

arrangement 30, wherein a free end of the lower branch 74 faces towards a side wall 36.

List of Reference Numerals:

1 0 refrigerated area

1 2 compartment

14 compartment

16 compartment

1 8 shelf

20 shelf

22 foodstuff

24 item

26 seal

30 packaging arrangement, secondary packaging

32 inner volume

34 boundary wall

35 boundary wall

36 boundary wall

37 boundary wall

38 boundary wall

39 surface

40 fastening member

42 slat

44 fastening member

46 flap

47 socket

48 fold line

50 fastening member

52 lid segment

54 l id segment

56 l id segment

60 fastening member

62 magnetic or ferromagnetic element

64 magnetic element

66 magnetic element magnetic element fastening member branch

branch

connecting portion unloading opening