U.S. patent application number 14/236590 was filed with the patent office on 2014-06-19 for shock absorbing lining for a transport container.
This patent application is currently assigned to Sanofi-Aventis Deutschland GmbH. The applicant listed for this patent is Robin Einwachter, Hendrik Hoppe. Invention is credited to Robin Einwachter, Hendrik Hoppe.
Application Number | 20140166520 14/236590 |
Document ID | / |
Family ID | 46545786 |
Filed Date | 2014-06-19 |
United States Patent
Application |
20140166520 |
Kind Code |
A1 |
Hoppe; Hendrik ; et
al. |
June 19, 2014 |
Shock Absorbing Lining for a Transport Container
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.
Inventors: |
Hoppe; Hendrik; (Frankfurt
am Main, DE) ; Einwachter; Robin; (Frankfurt am Main,
DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Hoppe; Hendrik
Einwachter; Robin |
Frankfurt am Main
Frankfurt am Main |
|
DE
DE |
|
|
Assignee: |
Sanofi-Aventis Deutschland
GmbH
Frankfurt am Main
DE
|
Family ID: |
46545786 |
Appl. No.: |
14/236590 |
Filed: |
July 19, 2012 |
PCT Filed: |
July 19, 2012 |
PCT NO: |
PCT/EP2012/064155 |
371 Date: |
January 31, 2014 |
Current U.S.
Class: |
206/433 ;
206/594 |
Current CPC
Class: |
B65D 85/42 20130101;
B65D 81/127 20130101 |
Class at
Publication: |
206/433 ;
206/594 |
International
Class: |
B65D 81/127 20060101
B65D081/127 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 2, 2011 |
EP |
11176239.9 |
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.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a U.S. National Phase Application
pursuant to 35 U.S.C. .sctn.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
[0002] 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
[0003] 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.
[0004] Otherwise, entire stacks of vitreous bodies or even filled
cartridges could be contaminated by a single damaged or cracked
vitreous body or cartridge.
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] 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.
[0016] 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.
[0017] 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.
[0018] 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.
[0019] 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.
[0020] 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.
[0021] 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.
[0022] 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.
[0023] 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.
[0024] 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.
[0025] The at least one shock absorbing element made of an elastic
material may comprise a solid and homogeneous structure.
[0026] 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.
[0027] 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.
[0028] 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.
[0029] 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.
[0030] 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.
[0031] 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.
[0032] 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.
[0033] The term "drug" or "medicament", as used herein, means a
pharmaceutical formulation containing at least one pharmaceutically
active compound,
[0034] 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,
[0035] 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,
[0036] 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,
[0037] 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.
[0038] 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.
[0039] 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-(.omega.-carboxyheptadecanoyl)-des(B30) human insulin and
B29-N-(.omega.-carboxyheptadecanoyl) human insulin.
[0040] 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-Gl-
u-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly--
Ala-Pro-Pro-Pro-Ser-NH2.
[0041] Exendin-4 derivatives are for example selected from the
following list of compounds:
[0042] H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,
[0043] H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,
[0044] des Pro36 Exendin-4(1-39),
[0045] des Pro36 [Asp28] Exendin-4(1-39),
[0046] des Pro36 [IsoAsp28] Exendin-4(1-39),
[0047] des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),
[0048] des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),
[0049] des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),
[0050] des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),
[0051] des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),
[0052] des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39);
or
[0053] des Pro36 [Asp28] Exendin-4(1-39),
[0054] des Pro36 [IsoAsp28] Exendin-4(1-39),
[0055] des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),
[0056] des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),
[0057] des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),
[0058] des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),
[0059] des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),
[0060] des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28]
Exendin-4(1-39),
[0061] wherein the group -Lys6-NH2 may be bound to the C-terminus
of the Exendin-4 derivative;
[0062] or an Exendin-4 derivative of the sequence
[0063] des Pro36 Exendin-4(1-39)-Lys6-NH2 (AVE0010),
[0064] H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,
[0065] des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,
[0066] H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,
[0067] H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28]
Exendin-4(1-39)-NH2,
[0068] des Pro36, Pro37, Pro38 [Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
[0069] H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
[0070] H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
[0071] H-(Lys)6-des Pro36 [Trp(O2)25, Asp28]
Exendin-4(1-39)-Lys6-NH2,
[0072] H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25]
Exendin-4(1-39)-NH2,
[0073] H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-NH2,
[0074] H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-NH2,
[0075] des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
[0076] H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
[0077] H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
[0078] H-(Lys)6-des Pro36 [Met(O)14, Asp28]
Exendin-4(1-39)-Lys6-NH2,
[0079] des Met(O)14 Asp28 Pro36, Pro37, Pro38
Exendin-4(1-39)-NH2,
[0080] H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2,
[0081] H-An-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2,
[0082] des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
[0083] H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
[0084] H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
[0085] H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-Lys6-NH2,
[0086] H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25]
Exendin-4(1-39)-NH2,
[0087] H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2,
[0088] H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25,
Asp28] Exendin-4(1-39)-NH2,
[0089] des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
[0090] H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25,
Asp28] Exendin-4(S1-39)-(Lys)6-NH2,
[0091] H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25,
Asp28] Exendin-4(1-39)-(Lys)6-H2;
[0092] or a pharmaceutically acceptable salt or solvate of any one
of the afore-mentioned Exendin-4 derivative.
[0093] 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.
[0094] 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.
[0095] Antibodies are globular plasma proteins (.about.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.
[0096] 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 .beta. sheets
create a "sandwich" shape, held together by interactions between
conserved cysteines and other charged amino acids.
[0097] There are five types of mammalian Ig heavy chain denoted by
.alpha., .delta., .epsilon., .gamma., and .mu.. The type of heavy
chain present defines the isotype of antibody; these chains are
found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
[0098] Distinct heavy chains differ in size and composition;
.alpha. and .gamma. contain approximately 450 amino acids and
.delta. approximately 500 amino acids, while .mu. and .epsilon.
have approximately 550 amino acids. Each heavy chain has two
regions, the constant region (C.sub.H) and the variable region
(V.sub.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 .gamma., .alpha. and
.delta. have a constant region composed of three tandem Ig domains,
and a hinge region for added flexibility; heavy chains .mu. and
.epsilon. 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.
[0099] In mammals, there are two types of immunoglobulin light
chain denoted by .lamda. and .kappa.. 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, .kappa. or .lamda.,
is present per antibody in mammals.
[0100] 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.
[0101] 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).
[0102] 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.
[0103] Pharmaceutically acceptable solvates are for example
hydrates.
[0104] 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
[0105] In the following, preferred embodiments of the invention
will be described in detail by making reference to the drawings in
which:
[0106] FIG. 1 schematically illustrates a transport configuration
according to the prior art,
[0107] FIG. 2 is illustrative of a transport container equipped
with a shock absorbing lining,
[0108] FIG. 3 shows an isolated perspective illustration of the
shock absorbing lining prior to insertion into a transport
container,
[0109] FIG. 4 is illustrative of a cross section of the shock
absorbing lining along A-A according to FIG. 2,and
[0110] FIG. 5 shows various samples of corrugated fiberboard-like
structures to be implemented as a shock absorbing element.
DETAILED DESCRIPTION
[0111] 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.
[0112] 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.
[0113] 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.
[0114] 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.
[0115] 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.
[0116] 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.
[0117] 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.
[0118] 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.
[0119] 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.
[0120] 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.
[0121] 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.
[0122] 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.
[0123] 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.
[0124] 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.
[0125] 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.
* * * * *