Note: Descriptions are shown in the official language in which they were submitted.
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Shock Absorbing Lining for a Transport Container
Description
Field of the 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 and Prior Art
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 Al 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 Figure
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
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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.
Objects of the Invention
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 of the Invention
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,
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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.
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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
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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
5 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
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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
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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
geoemetry.
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
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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 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,
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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(B28-630) 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-glutamyI)-des(B30)
human insulin; B29-N-(N-lithocholyl-Y-glutamyI)-des(B30) human insulin; B29-N-
(w-
carboxyheptadecanoy1)-des(B30) human insulin and B29-N-(w-
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.
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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,
5 des Pro36 Exendin-4(1-39),
des Pro36 [Asp28] Exendin-4(1-39),
des Pro36 [IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(0)14, Asp28] Exendin-4(1-39),
des Pro36 [Met(0)14, IsoAsp28] Exendin-4(1-39),
10 des Pro36 [Trp(02)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(02)25, IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1-39),
des Pro36 [Met(0)14 Trp(02)25, IsoAsp28] Exendin-4(1-39); or
des Pro36 [Asp28] Exendin-4(1-39),
des Pro36 [IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(0)14, Asp28] Exendin-4(1-39),
des Pro36 [Met(0)14, IsoAsp28] Exendin-4(1-39),
des Pro36 [Trp(02)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(02)25, IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1-39),
des Pro36 [Met(0)14 Trp(02)25, 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,
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H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36 [Trp(02)25, Asp28] Exendin-4(1-39)-Lys6-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Trp(02)25] Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-
NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-
NH2,
H-(Lys)6-des Pro36 [Met(0)14, Asp28] Exendin-4(1-39)-Lys6-NH2,
des Met(0)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,
H-(Lys)6-desPro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-(Lys)6-
NH2,
H-Lys6-des Pro36 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-39)-Lys6-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25] Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-
39)-
NH2,
des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-
NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(S1-39)-
(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-
39)-
(Lys)6-NH2;
or a pharmaceutically acceptable salt or solvate of any one of the afore-
mentioned
Exendin-4 derivative.
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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 [3 sheets create a "sandwich" shape, held together by interactions
between
conserved cysteines and other charged amino acids.
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There are five types of mammalian Ig heavy chain denoted by a, 6, E, y, and p.
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 y contain
approximately 450
amino acids and 6 approximately 500 amino acids, while p and have
approximately
550 amino acids. Each heavy chain has two regions, the constant region (CH)
and the
variable region (VH). 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 y, a and 6 have a constant region composed of three tandem Ig domains,
and a
hinge region for added flexibility; heavy chains p and 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 A and
K. 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,
K or A, 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.
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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 06-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.
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Brief Description of the Drawings
In the following, preferred embodiments of the invention will be described in
detail
5 by making reference to the drawings in which:
Figure 1 schematically illustrates a transport configuration
according to
the prior art,
10 Figure 2 is illustrative of a transport container
equipped with a shock
absorbing lining,
Figure 3 shows an isolated perspective illustration of the shock
absorbing
lining prior to insertion into a transport container,
Figure 4 is illustrative of a cross section of the shock
absorbing lining
along A-A according to Figure 2,and
Figure 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 Figures 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. Figures 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.
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As further shown in Figure 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 Figure 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
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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 Figure 2 across the substantially
cylindrical circumference of the vitreous body 32.
In Figure 3, a perspective illustration of a frame-like arranged shock
absorbing
lining 10 is illustrated. Here, the rectangular or substantially quadratic
shaped lining
comprises four segments 12, 14, 16, 18 wherein the segments 12, 16 and the
10 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 Figure 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.
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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.
Figure 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.
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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 Figure 5 or combinations
thereof.
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Reference Numbers
9 mechanical impact
10 lining assembly
5 11 lower edge
12 lining segment
13 creasing line
14 lining segment
15 open end
10 16 lining segment
18 lining segment
20 shock absorbing element
22 shock absorbing element
24 shock absorbing element
15 26 shock absorbing element
28 bottom wall
gap
32 cartridge
34 beaded cap
20 36 bulged edge
38 side wall
transport container
42 carrier
44 corrugated fiberboard-like structure
25 46 corrugated fiberboard-like structure
48 corrugated fiberboard-like structure
corrugated fiberboard-like structure
52 corrugated fiberboard-like structure
54 corrugated fiberboard-like structure
30 56 corrugated fiberboard-like structure
