US20140166520A1

US20140166520A1 - Shock Absorbing Lining for a Transport Container

Info

Publication number: US20140166520A1
Application number: US14/236,590
Authority: US
Inventors: Hendrik Hoppe; Robin Einwächter
Original assignee: Sanofi Aventis Deutschland GmbH
Current assignee: Sanofi Aventis Deutschland GmbH
Priority date: 2011-08-02
Filing date: 2012-07-19
Publication date: 2014-06-19
Also published as: EP2739548A1; CA2841895A1; WO2013017416A1; JP2014521564A

Abstract

The present invention relates to a shock absorbing lining for a transport container, the lining comprising: a carrier to be arranged along a lateral side wall of the container and being adapted to support at least one shock absorbing element extending laterally inwardly from the carrier at a predefined distance from a lower edge thereof.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a U.S. National Phase Application pursuant to 35 U.S.C. §371 of International Application No. PCT/EP2012/064155 filed Jul. 19, 2012, which claims priority to European Patent Application No. 11176239.9 filed Aug. 2, 2011. The entire disclosure contents of these applications are herewith incorporated by reference into the present application.

FIELD OF INVENTION

The present invention relates to a shock absorbing lining for a transport container, being particularly adapted for transportation of vitreous items, in particular of vitreous bodies for cartridges to be filled with a liquid medicament.

BACKGROUND

Particular pharmaceutical products like liquid medicaments require packaging by way of packaging material being inert to the medicament. In order to cope with given hygienic standards, vitreous bodies, e.g. made of glass are commonly used for packaging of liquid medicaments. Prior or during bottling of the medicament into such vitreous bodies, the bodies, typically of tubular shape have to be transported in a reliable, safe and unharmful way. Especially for mass-production processes, cracking and disintegration of such vitreous packaging units has to be prevented.
Otherwise, entire stacks of vitreous bodies or even filled cartridges could be contaminated by a single damaged or cracked vitreous body or cartridge.
Document DE 103 39 830 A1 already discloses a transport container made of plastic having an inner lining on a bottom portion and its side walls. There, the lining is composed of a liquid absorbing foam.
In particular with vitreous bodies 32 as illustrated in the sketch of FIG. 1, the problem may arise, that the bodies or cartridges 32 arranged in an upright orientation on a bottom wall 28 of a transport container 40 mutually abut with each other in particular with a bulged portion 36 located at a proximal end of the vitreous body 32. When densely packed, the items or bodies 32 are in direct contact with each other by way their bulged portions 36. Moreover, the bulged portions 36 of items 32 arranged adjacent a rigid side wall 38 of the transport container 40 get in close or direct contact with said side wall portion 38.
In particular in the event the container 40 becomes subject to an inevitable lateral shock effect 9, mechanical impact may propagate across the arrangement of items 32. Due to a densely packed arrangement and due to the contact configuration of the proximal bulged portions 36, externally applied shocks 9 may vastly extend and propagate across the arrangement of vitreous items 32. As a consequence, a single or several items 32 may easily become subject to fracture or cracking in response to such external impact 9 induced or transferred via lateral side walls 38.
It is therefore an object of the present invention to provide an improved mass transport container particularly designed for transportation of vitreous bodies and providing improved shock absorbing properties. By way of the improved transport configuration, the likelihood and degree fracture or damage of items disposed therein should be significantly reduced. Moreover, an improved protection against externally applied mechanical impact should be attained for items stored therein. Despite an improved protection, the container should still provide a high packing density for items stored therein.

SUMMARY

The present invention provides a shock absorbing lining for a transport container. The lining comprises a carrier to be arranged along a lateral side wall of the container and being adapted to support at least one shock absorbing element extending laterally inwardly from the carrier at a pre-defined distance from a lower edge thereof. The carrier is adapted and designed to be positioned at the inner surface of the side wall of the container. The at least one shock absorbing element is designed to protrude inwardly from the preferably flat-shaped carrier, hence, away from the sidewall of the container and towards the lateral side walls of items to be stored therein. The pre-defined distance between the at least one shock absorbing element and the lower edge of the carrier is larger than zero. By means of a non-zero distance of the shock absorbing element from the lateral edge of the carrier, a lateral receptacle adjacent to a bottom portion of the container can be formed and provided.
This way, a lateral receptacle or recess can be provided in a transition between the bottom portion of the container and a shock absorbing lining covering the side wall the container, since the lower edge of the carrier will be typically supported by the bottom portion of the transport container when assembled therein.
The shock absorbing element is particularly adapted to transfer mechanical impact between the lateral side wall of the container and lateral side walls of items to be transported in said container. Since the at least one shock absorbing element is arranged at a pre-defined distance from a lower edge of the carrier, and since the carrier is to be positioned with its lower side edge on the bottom wall of the container, a lateral gap or recess is formed between the at least one shock absorbing element, the carrier and the bottom wall of the container.
Said lateral recess is designed and adapted to receive a laterally or radially outwardly extending or bulged portion of the vitreous item, e.g. of a cartridge. In effect, by way of the at least one laterally inwardly protruding shock absorbing element, the vitreous item can be positioned in the transport container in such a way, that there remains a respectable lateral and/or vertical gap between the carrier or the lateral side wall of the container and the bulged portion of the vitreous body. By way of the at least one shock absorbing element, the vitreous items can only be placed in the transport container in such a configuration, that their bulged, hence, their lower or proximal edge is no longer in impact transmitting contact with the lateral side wall of the transport container.
As a consequence, inevitable mechanical shocks or respective impact incident on the transport container will exclusively be transferred via the shock absorbing element to a lateral side wall portion of the items disposed therein. By way of the at least one shock absorbing element, a direct contact configuration between the laterally extending bulged portion of the vitreous item and the rather rigid side wall of the container can be abrogated and direct impact propagation between the lateral side wall of the container and the rather sensitive or crack-prone bulged portion of the vitreous item no longer occurs.
According to a preferred aspect, the distance between a bottommost shock absorbing element and the lower edge of the carrier is at least 5 mm.
Preferably, the distance between the bottommost shock absorbing element and the lower edge of the carrier is selected to accommodate a bulged portion of the transport item to be disposed and arranged in the transport container, preferably in a densely packed configuration. The bulged portion of the transport item evolves in the manufacturing process of the vitreous items. Hence, the bulged portion typically comprises a melted and radially thickened edge of a vitreous body.
The vertical position as well as the lateral thickness of the bottommost shock absorbing element is designed such, that a melted or bulged edge of the vitreous body can be positioned in a lowermost gap formed between the bottom wall, the bottommost shock absorbing element and the carrier.
According to another preferred embodiment, the at least one shock absorbing element comprises at least one undulation or a corrugated structure extending substantially parallel to the lower edge of the carrier. By way of an undulation the vertical position of contact points between the shock absorbing element and adjacently arranged transport items may vary. This way, mechanical impact or shock being incident to the side wall of the transport container may distribute or dissipate to a multiplicity of adjacently arranged transport items at different vertical positions. Hence, support or abutment positions of transport items adjacently arranged with respect to each other may vary at least in a direction perpendicular to the direction of propagation of the undulation.
Additionally, the undulating shock absorbing element may also enhance mechanical stability of the shock absorbing lining itself. By way of an undulated and laterally inwardly protruding undulated structure, stiffness of a comparatively thin carrier of the shock absorbing lining can be advantageously increased, thereby facilitating and improving the general handling of the lining.
In a further preferred aspect, the carrier comprises a plurality of substantially parallel oriented shock absorbing undulations co-extending or co-propagating along the carrier at different distances from the lower edge of the carrier. Instead or additional to a parallel orientation of shock absorbing undulations among each other and/or with respect to the elongation of the lower edge of the carrier, it is even conceivable that the shock absorbing undulations extend at a predefined angle with respect to the lower edge of the carrier.
The amplitude of the at least one undulation preferably extends substantially perpendicular to its direction of propagation. Hence, the profile of the at least one undulation may resemble a sinusoidal shape or waveform. Preferably, an outermost undulation is separated from the lower edge of the carrier by a distance substantially equal to or exceeding the distance between adjacently located and/or co-propagating undulations.
According to another preferred embodiment, the at least one shock absorbing element comprises a rubber material protruding from the carrier and having a thickness between 1 mm to 4 mm, preferably between 2 mm and 3 mm. By means of the elastically deformable rubber material, the shock absorbing element is preferably made of, mechanical impact impinging externally to lateral side walls of the transport container can be effectively absorbed or at least damped. Additional or alternative to a rubber material, also plastic materials like elastomeric or thermoplastic materials can be used for providing the at least one shock absorbing element.
According to a further preferred embodiment, the carrier is made of or comprises a plastic material. For instance, the carrier may comprise a layer of thermoplastic or elastomeric material and comprise a flat and even shaped carrier structure for the at least one shock absorbing element attached thereto. The carrier may comprise a shape substantially corresponding with the size and geometry of surrounding side wall segments of the transport container.
Moreover, the entire shock absorbing lining can be designed as an insert to be releasably arranged in the transport container. The shock absorbing lining may serve as a protective or shock absorbing structure to be arranged between comparatively rigid side wall segment of the transport container and laterally arranged vitreous items.
In still another embodiment, the carrier and the at least one shock absorbing element are integrally formed. Hence, carrier and shock absorbing element may comprise the same material and may be manufactured as a plastic or elastomeric component. Moreover, it is conceivable, that the shock absorbing lining is manufactured as a two- or more component injection molded structure comprising for instance a plastic carrier and an elastomeric or rubber-based shock absorbing element firmly bonded thereto.
The at least one shock absorbing element made of an elastic material may comprise a solid and homogeneous structure.
In a further embodiment, the at least one shock absorbing element comprises a corrugated fiberboard-like structure of various flute sizes in simplex and/or duplex arrangement. Hence, the shock absorbing element may comprise one or several layers having corrugated flutes inbetween. Generally, a large variety of flute sizes, like “A”, “B”, “C”, “E”, and “F” or microflute are generally conceivable as corrugated flute. Moreover, the fiberboard-like internal structure of the shock absorbing element may be of single wall-, hence simplex and/or of double wall-type, resembling a duplex arrangement. The shock absorbing element can be made of a paper-based material but may also comprise a correspondingly shaped plastic or elastomeric material.
In still another preferred embodiment, the shock absorbing lining comprises at least two segments that correspond in size and geometry with at least two adjacently arranged lateral side walls of the transport container. Preferably, the shock absorbing lining comprises three or even four segments to be arranged at and/or along the inside facing side walls of a rectangular transport container.
It is of further benefit, when the shock absorbing lining comprises one or several creasing- or fold lines in order to separate or to distinguish the various segments that match and correspond with corresponding lateral side walls of the transport container. The shock absorbing lining as a whole may comprise an elongated stripe or strip having up to four or even more adjacently arranged segments separated by creasing- or fold lines substantially extending perpendicular to the lower edge of the lining's carrier. When appropriately folded, the shock absorbing lining may correspond and match with the inside facing side wall structure of the transport container. It may then serve as an inside facing cover for the rather rigid side walls of the transport container.
Depending on the structure of the transport container the number of lining segments may vary. It is generally conceivable that the container, in particular its circumfering side wall structure is of triangular, pentagonal, hexagonal or other polygonal shape. In this case the lining comprises a corresponding shape and geometry.
According to another independent aspect, the invention also relates to a transport container of substantially rectangular geometry having a substantially flat shaped bottom portion to support numerous transport items, such like vitreous bodies or cartridges filled or to be filled with a liquid medicament. The transport container further has at least four lateral side walls that form a circumferential frame for the bottom portion. Furthermore, the transport container is equipped with at least one shock absorbing lining as described above. The shock absorbing lining is arranged at the inner face of at least lateral side wall.
Here, it is of further benefit, when the shock absorbing lining is unfastened or loosely arranged inside the transport container. This way, a releasing and disassembling of shock absorbing lining and transport container can be easily provided. In particular, when empty transport containers are to be stacked on top of each other, the shock absorbing linings can be taken away and stored or transported elsewhere for not getting damaged when empty transport containers are stacked on one another.
According to another embodiment, the transport container has a plurality of cartridges disposed therein wherein each cartridge has a vitreous body and is at least partially filled with a medicament, which is for instance to be administered by way of injection.
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 protein, 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-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.
Exendin-4 for example means Exendin-4(1-39), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
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 [IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, IsoAsp28] 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, IsoAsp28] Exendin-4(1-39); or
des Pro36 [Asp28] Exendin-4(1-39),
des Pro36 [IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, IsoAsp28] 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, IsoAsp28] 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-An-(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)5des 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-H2;
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 70-110 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; α 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, α 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 110 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 211 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. HCl 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 in detail by making reference to the drawings in which:

FIG. 1 schematically illustrates a transport configuration according to the prior art,

FIG. 2 is illustrative of a transport container equipped with a shock absorbing lining,

FIG. 3 shows an isolated perspective illustration of the shock absorbing lining prior to insertion into a transport container,

FIG. 4 is illustrative of a cross section of the shock absorbing lining along A-A according to FIG. 2,and

FIG. 5 shows various samples of corrugated fiberboard-like structures to be implemented as a shock absorbing element.

DETAILED DESCRIPTION

The transport container 40 as indicated in FIGS. 1 and 2 comprises a substantially flat-shaped bottom wall 28 and a side wall 38 extending substantially perpendicular relative to the orientation of the bottom wall 28. FIGS. 1 and 2 further show an item 32 to be transported and stored in such a transport container 40. Said item 32 comprises for instance a vitreous body, e.g. made of transparent glass and further has a beaded cap 34 at an upper distal end. Opposite the upper end, the vitreous body 32 comprises a bulged edge 36 extending laterally outwardly. This bulged portion 36 is a remainder of the manufacturing process of the glass cylinder 32, which formed by way of an appropriate melting process.
As further shown in FIG. 2, the shock absorbing lining 10 comprises a carrier 42 of flat and even shape, which almost entirely abuts with the inside facing surface of the side wall 38 of the transport container 40. The shock absorbing lining 10 further comprises or supports numerous shock absorbing element 20, 22, 24, 26 that extend and protrude inwardly from the carrier 42.
Any one of the shock absorbing elements 20, 22, 24, 26 comprises an undulation that extends and propagates in horizontal direction, e.g. substantially parallel to a lower edge 11 of the carrier 42. By means of its lower edge 11, the carrier 42 and the entire shock absorbing lining 10 can be supported by the bottom wall 28 of the transport container 40. Hence, the shock absorbing lining 10 is positioned in an upright orientation and stands with its lower side edge 11 on the bottom wall 28 of the container 40.
Since the undulations 20, 22, 24, 26 are preferably rigidly attached to the carrier 42, a predefined gap 30 between the bottommost undulation 26 and the lower edge 11, hence between the undulation 26 and the bottom wall 28 can be provided. By keeping a pre-defined distance 30 between the bottom wall 28 and the bottommost undulation 26, a respective lateral recess for the bulged portion 36 of a vitreous item 32 can be provided at a lateral side wall 38.
As illustrated in FIG. 2, such a receptacle for the laterally outwardly extending bulged portion 36 is formed by the lowermost undulation 26, the carrier 42 and the bottom wall 28 of the transport container 40. This way, the vitreous item 32 can be placed in the container 40 by establishing a lateral abutment with numerous shock absorbing elements 20, 22, 24, 26 while its laterally extending bulged portion 36 does not get in contact with the side wall 38 or with the carrier 42 of the shock absorbing lining 10.
Mechanical shock or mechanical impact 9 impinging on the side wall 38 of the transport container 40 may laterally propagate to the vitreous body 32 across numerous shock absorbing elements 20, 22, 24, 26. This way, massive point loads acting on the laterally extended bulged portion 36 can be effectively avoided and inevitable mechanical loads can be smoothly and evenly distributed in axial direction, hence vertically in the sketch of FIG. 2 across the substantially cylindrical circumference of the vitreous body 32.
In FIG. 3, a perspective illustration of a frame-like arranged shock absorbing lining 10 is illustrated. Here, the rectangular or substantially quadratic shaped lining 10 comprises four segments 12, 14, 16, 18 wherein the segments 12, 16 and the segments 14, 18 comprise substantially equal geometries. The unfolded and not explicitly illustrated shock absorbing lining 10 comprises three creasing- or fold lines 13 extending substantially perpendicular to the lower edges 11 of the various lining segments 12, 14, 16, 18.
The creasing- or fold lines 13 may be designed as embossed, perforated or otherwise structurally weakened lines in order to facilitate and/or to defined a respective folding into a configuration as shown in FIG. 3. The four segment 12, 14 16, 18 of the shock absorbing lining 10 are separated by three creasing- or fold lines 13, whereas the segments 12, 14 remain unconnected at an open end 15. This way, the shock absorbing lining 10 can be flexibly arranged inside a correspondingly shaped transport container 40 and may easily compensate eventual production or geometric tolerances of such containers 40. The mentioned opened configuration of the lining 10 is also beneficial for separately storing and transporting such linings 10 independent from the transport container 40.
By providing an opened rather than a closed frame structure for the shock absorbing lining, a comparatively extensive abutment across the entire surface of shock absorbing lining segments 12, 14, 16, 18 and respective lateral side wall portions 38 of the transport container 40 can be effectively provided. The shock absorbing undulations 20, 22, 24, 26 typically extend along the entire width or extension of various lining segments 12, 14, 15, 18 between bordering fold lines 13 or free ends 15.
The undulations of the shock absorbing elements 20, 22, 24, 26 propagate and extend along or parallel with the lower edge 11 of the carrier 42. The amplitude of the undulations of the shock absorbing elements 20, 22, 24, 26 varies in vertical direction, hence substantially perpendicular to the lower edge 11, whereas the thickness of the undulations 20, 22, 24, 26 in a direction normal to the plane of the carrier 42 is substantially constant.
As indicated in the cross section A-A according FIG. 4, the thickness of the undulations or the shock absorbing elements 20, 22, 24, 26 is almost twice as large as the thickness of the carrier 42. However, geometrical dimensions, number of and distance between the undulations of the shock absorbing elements 20, 22, 24, 26 may vary according to the size and type of the vitreous items 32 to be transported in the transport container 40.
It is intended, that rather fragile items 32 are provided with a shock absorbing lining that provides a rather large shock absorbance. Rather robust items 32 can be transported by way of a lining being optimized to provide a maximum packaging density.
Moreover, it is to be noted, that the illustrated shock absorbing lining provides a good shock absorbance and a homogeneous distribution of mechanical impact to items arranged or densely packed in the transport container. Also, the shock absorbing lining is rather thin and is therefore hardly affects the available storage space provided by the transport container.
FIG. 5 is finally illustrative of various different corrugated fiberboard-like structures of different flute sizes in various simplex arrangements 44, 46, 48, 50 as well as in duplex arrangement 52, 54, 56. For instance, the corrugated structure 44 corresponds to an F-flute, structure 46 represents an E-flute, structure 48 represents a B-flute and corrugated structure 50 refers to a C-flute.
The duplex structure 52 resembles a FE-flute, structure 54 is illustrative of an EB-flute and structure 56 schematically shows a BC-flute. When designed as a corrugated fiberboard-like structure, the undulations of the shock absorbing elements 20, 22, 24, 26 may comprise paper-based fiberboard or may comprise a plastic material resembling or comprising at least in parts one of the corrugated structures 44, 46, 48, 50, 52, 54, 56 as shown in FIG. 5 or combinations thereof.

Claims

1-12. (canceled)

13. A transport container of substantially rectangular geometry having a substantially flat shaped bottom portion, at least four lateral side walls and at least one shock absorbing lining arranged at the inner face of at least one lateral side wall, wherein the shock absorbing lining comprising:

a carrier arranged along the at least one lateral side wall of the container and supporting at least one shock absorbing element extending laterally inwardly from the carrier at a predefined distance from a lower edge thereof, wherein the shock absorbing element comprises at least one undulation extending substantially parallel to the lower edge of the carrier.

14. The transport container according to claim 13, wherein the distance between a bottommost shock absorbing element and the lower edge of the carrier is at least 5 mm.

15. The transport container according to claim 13, wherein the distance between the bottommost shock absorbing element and the lower edge is selected to accommodate a bulged portion of a transport item to be disposed in the transport container.

16. The transport container according to claim 13, wherein the carrier comprises a plurality of substantially parallel oriented shock absorbing undulations co-extending along the carrier at different distances from the lower edge of the carrier.

17. The transport container according to claim 13, wherein the at least one shock absorbing element comprises a rubber material protruding from the carrier and having a thickness between 1 mm to 4 mm, preferably between 2 mm and 3 mm.

18. The transport container according to claim 13, wherein the carrier is made of a plastic material.

19. The transport container according to claim 13, wherein the carrier and the at least one shock absorbing element are integrally formed.

20. The transport container according to claim 13, wherein the at least one shock absorbing element comprises a corrugated fiberboard-like structure of various flute sizes in simplex and/or duplex arrangement.

21. The transport container according to claim 13, having at least two segments that correspond in size and geometry with at least two adjacently arranged side walls of the transport container.

22. The transport container according to claim 21, wherein the segments are separated by a creasing- or fold line.

23. The transport container according to claim 13, wherein the shock absorbing lining is unfastened arranged inside the transport container.

24. The transport container according to claim 13, having a plurality of cartridges disposed therein, said cartridges having a vitreous body and being at least partially filled with a medicament.