[0001] The present invention relates to containers having a plurality of chambers chiefly
for use in the field of medicine, and more particularly to flexible containers of
plastics having a plurality of chambers for accommodating liquid preparations, powder
preparations or solid preparations, and partition means dividing the container into
the chambers and permitting communication between the chambers when required.
[0002] Flexible containers of plastics have heretofore been used in the field of medicine
which have a plurality of chambers, and partition means dividing the container into
the chambers and permitting communication between the chambers. Since such a container
is likely to permit penetration of moisture or gas even if in a very small amount,
there arises a need to place the container, along with a desiccant, into an expensive
outer bag having barrier properties against moisture and gas when the container is
used for separately preserving an antibiotic or like medicinal which is hygroscopic
and becomes unstable with time, and a liquid preparation such as physiological saline,
glucose or like solution or dilution. Nevertheless, the desiccant, which absorbs water
from the liquid preparation, fails to fully dry up the hygroscopic medicinal and further
causes concentration of the liquid preparation. Because of this drawback, it has not
been practice to preserve the hygroscopic and unstable antibiotic or like medicinal
and the liquid preparation as separately accommodated in the flexible container of
plastics.
[0003] For this reason, medicinals, such as antibiotics, which become unstable with time
are preserved in moisture- and gas-impermeable vials or like containers before use.
When to be administered to the patient, the medicinal is mixed or diluted with, or
dissolved in, physiological saline, glucose solution or like dissolving liquid or
diluent which is preserved separately.
[0004] However, this method is cumbersome to practice and involves the hazard of contamination
with bacteria during the handling procedure. Containers have therefore been developed
which comprise a glass vial having enclosed therein an unstable antibiotic and a dissolving
liquid-containing flexible container portion of plastics joined to the vial in combination
therewith, with a piercing needle provided therebetween (see, for example, Unexamined
Japanese Patent Publication HEI 2-1277). These containers have the advantage that
the contents can be mixed together with ease aseptically, whereas difficulties are
encountered in discarding the container because a very complicated procedure is needed
for separating the container into the glass vial, flexible container portion and piercing
implement for disposal. Thus, the container has a problem as the disposal of medical
wastes which has attracted attention presently, i.e., the problem of failing to fulfill
the requirement of easy disposal.
[0005] Also known are containers having a plurality of chambers for accommodating other
medicinal which is readily oxidizable, such as amino acid solution containing tryptophan,
and a sugar or electrolytic solution (see, for example, Examined Japanese Patent Publication
SHO 63-20550). The container of this type must be preserved as placed in an expensive
moisture- and gas-barrier outer bag together with an oxygen absorber. In this case,
the latter preparation (sugar or electrolyte solution) on which the absorber need
not act is also accommodated in the outer bag along with the medicinal. The outer
bag therefore requires a larger capacity, an oxygen absorber having an increased capacity
to absorb oxygen or an increased amount of absorber, and a larger amount of moisture-
and gas-barrier material, hence the drawback of an increased cost.
[0006] EP-A-263571 and EP-A-109983 do also disclose plastic containers having one or a plurality
of chambers which are entirely covered with cover means exhibiting moisture- and gas-barrier
properties.
[0007] Earlier, non-prepublished European Patent Application EP-A-513364 discloses a plastic
container having container portions which form a plurality of chambers, at least one
container portion having no cover and at least one container portion having a cover,
the cover being made of a flexible film having moisture- and gas-barrier properties
and forming a closed space around the covered container portion, said closed space
containing a desiccant and/or an oxygen absorber.
[0008] An object of the present invention is to provide a flexible container of plastics
having a plurality of chambers and usable for accommodating and preserving liquid
preparations, powder preparations or solid preparations which are hygroscopic or susceptible
to oxidation.
[0009] Another object of the present invention is to provide such a container which can
be prepared with use of a reduced amount of expensive moisture- and gas-barrier film
and which is therefore inexpensive.
[0010] Still another object of the present invention is to provide a container of the type
mentioned which need not include a glass vial and which is therefore easy to dispose
of.
[0011] Another object of the present invention is to provide such a container wherein at
least one of the chambers contains a liquid, powder or solid medicinal preparation
which is hygroscopic or susceptible to oxidation, only this chamber being separated
from outside moisture and oxygen and adapted to prevent the preparation from oxidation
or absorbing moisture without enclosing any oxygen absorber nor desiccant therein.
[0012] Other features of the present invention will become apparent from the following description.
[0013] The present invention provides a container having a plurality of chambers for accommodating
a liquid, powder or solid preparation and partition means dividing the container into
the chambers and permitting communication between the chambers when required, the
container comprising a flexible body made of plastics and having container portions
which form said plurality of chambers, at least one but not all of said chambers being
enclosed within a cover made of a flexible film having moisture- and gas-barrier properties
to form a closed space around said covered chamber(s), said closed space containing
an inert gas and/or dry gas but not accommodating a desiccant and/or an oxygen absorber,
the other chamber(s) being coverless.
[0014] In a specific embodiment the container is characterized in that it comprises a flexible
plastics container body forming the plurality of chambers, at least one of the chambers
being enclosed with a cover having a sealed periphery to form a closed space therein
around the chamber, the other chamber or chambers being coverless, the cover being
made of a flexible film having moisture- and gas-barrier properties, the partition
means being formed by at least one weak seal portion easily openable by pressing the
chamber to give an increased internal pressure.
[0015] With the container of the present invention, a usual substance, such as a liquid,
powder or solid preparation which is not susceptible to oxidation or hygroscopic,
is accommodated in the coverless chamber among the chambers of the container. This
chamber is not enclosed with a moisture- and gas-impermeable cover and is therefore
low in moisture- and gas-barrier properties, whereas the substance contained therein
can be preserved for a long period of time as in common plastics containers since
the substance is a usual one.
[0016] On the other hand, a special substance, such as a liquid, powder or solid preparation
which is susceptible to oxidation and/or hygroscopic, is accommodated in the chamber
enclosed with the cover. The container body forming the chamber is made of plastics,
has moisture- and gas-permeability inherent to plastics although very slight and is
low in moisture- and gas-barrier properties. However, the cover enclosing the chamber
is made of a special film which is impermeable to moisture and gas, so that the special
substance can be preserved for a long period of time free of degradation despite the
low moisture- and gas-barrier properties of the plastics container body.
[0017] Accordingly, although made of flexible plastics, the container of the present invention
is usable free of any trouble for accommodating medicinals, such as antibiotics, which
are hygroscopic and become unstable with time, and liquid preparations such as dissolving
solutions or diluents.
[0018] The container of the present invention has the gas-impermeable cover of expensive
special film, whereas the cover is provided on the container only locally and can
therefore be formed with use of a small amount of the expensive special film. This
serves to minimize the rise in the cost of packaging. A further cost reduction can
be achieved since there is no need to enclose an oxygen absorber or desiccant in the
cover around the container body.
[0019] The plurality of chambers of the container of the invention are separated by at least
one weak seal portion, which can be opened by a pressure applied from outside to cause
the chambers to communicate with each other. Medicinal components can therefore be
mixed together aseptically while being held out of contact with outside air. The plastics
container body and the cover constituting the container are both flexible and readily
deformable, so that the container can be disposed of without the necessity of separation
more easily than containers wherein glass or metal is used.
FIG. 1 is an enlarged view in vertical section showing the container according to
an embodiment of the invention;
FIG. 2 is a front view of the same;
FIG. 3 is an enlarged sectional view of the portion A in FIG. 1;
FIG. 4 is an enlarged sectional view of the portion B in FIG. 1;
FIG. 5 is an enlarged sectional view of the portion C in FIG. 1;
FIG. 6 is a diagram illustrating stepwise a preferred example of process for producing
the container of the invention shown in FIG. 1;
FIG. 7 is a sectional view of a part of the plastics container body of the container
according to another embodiment of the invention;
FIG. 8 is a sectional view of a part of the cover of the container according to another
embodiment of the invention;
FIG. 9 shows a vertical section of the container according to a further embodiment
of the invention;
FIG. 10 is an enlarged sectional view of another example of the weak seal portion;
FIG. 11 is a perspective view of the container of the invention as enclosed with an
outer bag for storage or transportation;
FIG. 12 shows a vertical section of the container according to a further embodiment
of the invention;
FIG. 13 is a diagram illustrating stepwise another preferred example of process for
producing the container of the invention.
[0020] Embodiments of the present invention will be described below with reference to the
accompanying drawings.
[0021] FIGS. 1 and 2 show an embodiment of the invention of the type having two weak seal
portions.
[0022] Referring to FIG. 1 showing the embodiment, indicated at 1 is a flexible plastics
container body which has a discharge port 2.
[0023] The plastics container body 1 is prepared from two superposed sheets of flexible
plastics film 3 by heat seal the sheets together along the outer peripheral edges
thereof.
[0024] The film 3 is not a special one but is an inexpensive plastics film which is generally
used for making flexible plastics containers in the field of medicine.
[0025] FIG. 3 shows an example of film 3 comprising two layers, i.e., an outer layer 3a
of polyethylene (hereinafter referred to simply as "PE"), and an inner layer 3b of
a blend of PE and polypropylene (hereinafter referred to simply as "PP").
[0026] As seen in FIG. 1, the plastics container body 1 has two weak seal portions 8a, 8b
extending transversely of the container at an intermediate portion of its height and
formed by heat sealing.
[0027] The weak seal portions 8a, 8b are so adapted that the opposed sheets of film can
be separated from each other when required by utilizing the internal pressure of the
container which is increased as by pressing the container. The seal strength of the
weak seal portions must be smaller than that of the peripheral edge portion of the
container body 1.
[0028] The interior of the plastics container body 1 is divided into upper and lower two
chambers 1a, 1b by the weak seal portions 8a, 8b. The upper container portion 1A forming
the upper chamber 1a is enclosed with a cover 5, while the lower container portion
1B forming the lower chamber 1b is not provided with such a cover 5.
[0029] The cover 5 is made of a special film 6 which is impermeable to moisture and gas.
FIG. 5 shows an example of special film 6, i.e., a multi-layer film comprising an
outer layer 6a and an inner layer 6b of PE. The outer layer 6a is an aluminum-covered
film such as aluminum-laminated film, an aluminum-deposited film having high moisture-
and gas-impermeability or a two-layer film composed of polyvinylidene chloride and
polypropylene (PP). The polyvinylidene chloride forming the outer layer 6a may be
replaced by a silica-deposited film of polyvinyl alcohol.
[0030] With reference to FIG. 1, the cover 5 comprises two sheets of special film 6 which
are so arranged as to surround the upper container portion 1A. Of the peripheral portions
of the sheets of film 6, the parts which are out of contact with the upper container
portion 1A are heat sealed to each other, while the parts in contact with the portion
1A are heat sealed to the outer surface of the portion 1A as indicated at 6c, 6c.
As seen in FIG. 1, the bonded lower edge portions 6c, 6c are positioned between the
weak seal portions 8a, 8b.
[0031] A space portion 9 is provided between the seal portions 8a, 8b which is substantially
unsealed. FIG. 4 shows the heat sealed joint on an enlarged scale. The lower edge
portion 6c of the cover 5 is heat sealed to the space portion 9 between the seal portions
8a, 8b. This obviates the likelihood that the heat sealing operation will give an
increased seal strength to the weak seal portions 8a, 8b. In the case of the single
seal portion type, the lower edge portion of the cover 5 is heat sealed to the container
body 1 over the weak seal portion. Accordingly, it is desired to seal the edge portion
under such a condition that the seal strength of the weak seal portion is prevented
from increasing to the greatest possible extent, or the seal portion can be easily
separated free of trouble even if the seal strength is increased. Such a condition
can be determined by suitably selecting the material for the cover and determining
the heat sealing conditions as to temperature, time and pressure, whereas this involves
considerable limitations. In the case of the present embodiment shown in FIGS. 1 and
4, the lower edge portion 6c of the cover 5 can be sealed to the container body 1
without adversely affecting the seal strength of the weak seal portions 8a, 8b. This
leads to the advantage that the material for the cover 5 and the sealing conditions
are selectable with greater freedom than in the case of the single seal portion. Further
with the present embodiment wherein the lower edge portion 6c of the cover 5 is sealed
to the space portion 9 between the two weak seal portions 8a, 8b, the sealed joint
of the lower edge portion 6c is positioned at a greater distance from the chambers
1a, 1b of the container body as will be apparent from FIG. 4. This eliminates the
likelihood that the heat of the sealing operation will thermally degrade the medicinal
preparations accommodated in the chambers 1a, 1b. Medicinal preparations which are
hygroscopic or susceptible to oxidation include many that are susceptible to thermal
degradation, whereas the cover 5 lower edge portion can be heat sealed to the container
body without the likelihood of thermally degrading such a preparation. Even if one
of the two weak seal portions is opened, the other portion prevents the two chambers
from communicating with each other.
[0032] For example, a powder preparation 10 which is hygroscopic and/or susceptible to oxidation
is accommodated within the covered upper container portion 1A, while a usual liquid
preparation 11, for example, is accommodated within the coverless lower container
portion 1B.
[0033] The temperature at which the seals are formed is the highest for the entire peripheral
portion of the plastics container body 1 and the upper edge portion and side edge
portions of the cover 5, less high for the lower edge portions of the cover 5 sealed
to the container body 1, and lowest for the weak seal portions 8a, 8b. Consequently,
the weak seal portions 8a, 8b are the lowest of all the seals in bond strength.
[0034] FIG. 6 shows a preferred example of process for producing the present container shown
in FIGS. 1 and 2. The process will be described below with reference to FIG. 6, (a)
to (e).
[0035] First as shown in FIG. 6, (a), two sheets of plastics film shown in FIG. 3 are placed
over each other so that the inner layers 3b, 3b are brought into contact with each
other, and three sides of the assembly are heat-sealed at a temperature about 170
to about 200°C to make a plastics container body 1. Next, weak seal portions 8a, 8b
are formed at an intermediate portion of the container body at a temperature about
110 to about 130°C, and a discharge port 2 is attached to the body. Consequently formed
are an upper container portion 1A providing an upper chamber, and a lower container
portion 1B separated from the portion 1A and providing a lower chamber.
[0036] Subsequently, a liquid preparation 11 is filled into the lower container portion
1B through the unsealed part thereof. As seen in FIG. 6, (b), the unsealed parts of
the two container portions 1A, 1B are sealed, followed by heating for sterilization
with use of high-pressure steam, hot water or the like.
[0037] Thereafter, one side of the upper container portion 1A is then cut in an aseptic
atmosphere as seen in FIG. 6, (c) to open this portion, which is thereafter dried
when so required.
[0038] Next as shown in FIG. 6, (d), a cover 5 is provided over the upper container portion
1A using the special film shown in FIG. 5 and is heat-sealed on its three sides. The
lower edge portions 6c extending along the weak seal portions 8a, 8b are heat-sealed
at a temperature about 130 to 135°C at an intermediate area between the two portions
8a, 8b to avoid heat-sealing of the lower edge portions as superimposed on the weak
seal portions. One side of the cover 5 corresponding to the open side of the upper
container portion 1A is similarly left open.
[0039] Finally, a powder preparation 10, such as antibiotics, is accommodated in the upper
container portion 1A in an aseptic atmosphere, and the portion 1A and the cover 5
are thereafter sealed at the open side. FIG. 6 (e) shows the container thus obtained
and having the two chambers.
[0040] It is desired to replace the air in the space by N
2 before the opening is sealed for the removal of oxygen. The weak seal portions can
be formed, for example, by pressing a heated seal forming die against the container
body by a cylinder device. The die can be of a structure having two ridges spaced
apart by a predetermined distance and heatable to a controlled temperature by an electric
heater.
[0041] A liquid preparation can be placed into the covered container portion 1A and a liquid
or powder preparation into the coverless container portion 1B, for example, by a process
similar to the foregoing exemplary process. The container accommodating these preparations
can be prepared by attaching a discharge port 2 to the container body, then placing
the specified preparations into the respective container portions 1A, 1B, closing
the filling openings, sterilizing the contents by autoclave, then attaching a cover
5 to the upper container portion 1A, and thereafter sealing the side opening of the
cover.
[0042] With the containers of the present invention prepared by the processes shown in FIG.
6, the upper container portion 1A is formed by a plastics film comprising an outer
layer of PE and an inner layer of blend of PE and PP, so that the container portion
1A permits passage of moisture and gas (e.g. oxygen) although in a very small amount.
However, the upper container portion 1A is provided with the cover 5 of special film
having moisture- and gas-barrier properties, with the result that the cover 5 functions
to overcome the above disadvantage of the upper container portion 1A. Accordingly,
a powder preparation which is hygroscopic and/or susceptible to oxidation can be preserved
for a long period of time as accommodated in the upper container portion 1A although
this portion is formed by plastics. The weak seal portions 8a, 8b separating the upper
and lower container portions 1A, 1B are the lowest in seal strength of all the seals.
Therefore, when the container portion is pressed to increase the internal pressure
of the container portion, the increased pressure separates the weak seal portions
8a, 8b permitting the two container portions 1A, 1B to communicate with each other,
whereby the liquid preparation and the powder preparation within the respective container
portions 1A, 1B can be mixed together under an aseptic condition into a solution as
contemplated.
[0043] Examples of powder preparations for use in the above embodiment are antibiotic, anti-cancer,
steroid, antithrombotic, fibrinolytic, vitamin and like preparations which are hygroscopic
and susceptible to oxidation and to thermal degradation. Examples of useful liquid
preparations are physiological saline, glucose solution and like dissolving solutions
or diluents.
[0044] While the usual film for making the plastics container body is a multi-layer film
of the construction shown in FIG. 3, also usable is a single-layer or multi-layer
film prepared from at least one combination of resins selected from among PE, PP and
blends of these resins.
[0045] FIG. 7 shows as an example a three-layer film 35 which comprises an outer layer 31
of linear low-density polyethylene (hereinafter referred to briefly as "LLDPE"), an
intermediate layer 33 of resin mixture of LLDPE and low-crystalline (or amorphous)
ethylene/α-olefin elastomer, and an inner layer 34 of resin mixture of LLDPE and PP.
[0046] Further depending on the type of medicinal preparation to be enclosed, low-molecular
weight substances contained in the LLDPE present in the inner layer of the inner wall
are likely to undergo an inter-action with the preparation with lapse of time, possibly
producing a reaction product which would adversely affect the patient. Accordingly,
the LLDPE to be used for the inner layer 34 is pretreated at a high temperature in
a vacuum as by the devolatilization and stripping process to thereby reduce the content
of low-molecular-weight substances with up to about 30 carbon atoms to not higher
than a specified value, whereby the interaction between the medicinal preparation
and the inner-layer can be prevented favorably.
[0047] Further when a suitable amount of high-density polyethylene (HDPE) is incorporated
into each layer of the three-layer film 35 as required for giving improved heat resistance
to the film, containers can be formed with high stability to withstand sterilization
at a high temperature of at least 121°C, for example, with use of high-pressure steam
or hot water.
[0048] As special films for the cover, it is possible to use single-layer or multi-layer
sheets of polyvinylidene chloride, polyethylene terephthalate (PET), aluminum-covered
film, ethylene-vinyl alcohol copolymer (EVOH) or silica-deposited film. Preferably,
a silica-deposited film is used to form at least a layer of the sheet because of its
transparency and high impermeability to moisture and gas.
[0049] FIG. 8 shows a moisture- and gas-impermeable barrier film as an example of such film,
i.e., a three-layer film 46 which comprises an outer layer 43 of biaxially oriented
PET film, an intermediate layer 44 of silica-deposited PVA film and an inner layer
45 of low-density polyethylene (LDPE) and in which these layers are bonded to one
another with a urethane adhesive resin. When the cover is to be heat sealed directly
to the plastics container body, it is desirable to use a multi-layer film at least
for the cover so that the material of the innermost layer of the cover is the same
as the material of the outermost layer of the plastics container body, whereby a satisfactory
heat seal can be formed. For example, when the outermost layer of the container body
is LLDPE, it is desirable to use LLDPE for the innermost layer of the cover.
[0050] Although a powder preparation is enclosed in the chamber of the covered container
portion and a liquid in the chamber of the coverless container portion according to
the foregoing embodiment, the powder preparation and the liquid preparation can be
replaced by each other depending on the contemplated purpose.
[0051] A liquid preparation is accommodated in the covered container portion with a powder
preparation enclosed in the other container portion, for example, in the case where
the liquid preparation is an amino acid preparation or the like containing cysteine
or tryptophan added thereto and susceptible to oxidation, and the powder preparation
is a sugar, an electrolyte or a mixture thereof.
[0052] A liquid preparation is enclosed in the covered container portion with other liquid
preparation in the other container portion, for example, in the case where the former
liquid preparation is susceptible to oxidation, such as an amino acid preparation
containing cysteine or tryptophan, or a vitamin preparation, and the latter liquid
preparation is a sugar or electrolytic preparation.
[0053] Another example is such that the former liquid preparation is a readily oxidizable
fat emulsion or the like, and the latter preparation is a sugar or electrolytic preparation.
[0054] Further it is possible to enclose a solid preparation in one of the container portions
and a liquid preparation in the other container portion. Other examples of such powder,
liquid and solid preparations are various nutrient preparations and curing agents
which are given intravenously or enterally (tube or oral feeding).
[0055] Further cover may be made locally or entirely of an aluminum-covered film to shield
the interior from light. The aluminum-covered film used for the cover may be made
peelable locally or entirely when the preparation is to be used, if so desired.
[0056] While the foregoing embodiment is a container having two chambers for accommodating
a liquid preparation and one kind of powder preparation individually, such a container
can be provided with more than two chambers, for example, as shown in FIG. 9. Disposed
inside the cover 5 is a container portion 1A' having chambers 1a
1, 1a
2 for accommodating two kinds of powder preparations (or a powder preparation and a
solid preparation). A liquid preparation is accommodated in the coverless container
portion 1B. It is possible to provide a plurality of chambers for liquid preparations
besides powder or solid preparations. Weak seal portions are provided between these
chambers.
[0057] In the case where a liquid, powder or solid preparation susceptible to oxidation
is enclosed in the covered chambers la, it is desired to enclosed an inert gas, such
as nitrogen gas, carbon dioxide gas or argon gas, in the space inside the cover 5
around the container body 1. When a liquid, powder or solid preparation which is hygroscopic
is enclosed in the chambers la, it is desired to enclose dry air, dry nitrogen gas
or like dry gas in the space. When the inert gas is enclosed, the air in the space
is replaced by the inert gas. This ensures a greater effect to prevent oxidation.
When the dry gas is enclosed, the air in the space is replaced by the dry gas, which
therefore assures an enhanced moistureproof effect.
[0058] The medicinal preparations contained in the container can be given high stability
despite the lapse of time by the moisture- and gas-impermeable film covering the chamber
or chambers which must be moisture-proof and free of oxidation, and further by enclosing
the inert gas or dry gas in the space inside the cover around the container body,
without placing an oxygen absorber and/or desiccant into the space unlike the conventional
practice.
[0059] Two weak seal portions need not always be formed, but more than two seal portions
or a single seal portion can be provided. Further the weak seal portion need not always
be linear but can be V-shaped so as to project approximately toward the center of
the covered chamber. When a pressure is applied to one chamber with hand in this case,
the force acting to open the weak seal portion will concentrate on the V-shaped portion,
with the result that the medicinal components can be mixed together by opening the
weak seal portion with a relatively small pressure. In this case, however, there is
a likelihood that separation will inadvertently occur in the seal portion during storage
or transport of the container, so that it is desirable to carefully determine the
heat-sealing condition.
[0060] With the foregoing embodiment, the weak seal portion is formed by directly bonding
together the inner layers of two sheets forming the container body. Alternatively,
the weak seal portion may be formed by heat seal the two sheets together with a multi-layer
insert film held therebetween. FIG. 10 shows a modification wherein two-layer insert
film is used. Indicated at 3 is a container forming film which is a single-layer or
multi-layer film, at 18 is a sheet having a high heat seal strength on the innermost
layer of the film 3 at one side, and at 19 is a sheet having a low heat seal strength
on the innermost layer of the film 3 on the other side. The film portion 3 and the
sheet 19 form a weak seal portions 21a, 21b. For example, when the film 3 is a single-layer
film of PE or PP, the sheet 18 is made of the same material as the film 3, i.e., PE
or PP, and the sheet 19 is made of a blend of PE and PP. Two insert films can be used
which are each provided for the two weak seal portions respectively. The cover 5 may
be heat-sealed in register with the weak seal portion provided that the weak seal
portion is held weak, alternatively, the cover can be attached to the container body
using an adhesive or the like.
[0061] The container of the invention is preferably stored or transported as folded in two
at the weak seal portions 8a, 8b and as enclosed with an outer bag 50. When folded
in two in this case, the seal portion is prevented from opening due to a pressure
under the weight of superimposed containers or due to impact on falling.
[0062] As shown in FIG. 12, the discharging port 2' may be formed at one end the chamber
1a' which contains a powder preparation 10 such as antibiotic. In this case, the chamber
1b' containing a liquid such as a dissolving solution is closed. If a discharging
port is formed at a chamber containing a liquid such as dissolving solution, there
is a risk of inadvertently administering only the liquid without mixing with the powder
preparation especially in an emergency. Such risk can be eliminated by forming the
discharging port at the chamber containing the powder preparation such as antibiotic.
[0063] Another preferred process for producing the container of the invention is described
below with reference to FIG. 13, (a) to (j).
[0064] As shown in FIG. 13, (a), a discharge port hole 2a is formed in a two-layer plastics
film 3 like the one shown in FIG. 3.
[0065] Next as seen in FIG. 13, (b), a discharge port 2 is attached by heat seal to the
outer layer, i.e., the PE layer, of the film 3 in register with the hole 2a. The film
3 is then folded in two along a line through the discharge port 2 as shown in FIG.
13, (c).
[0066] Subsequently as seen in FIG. 13, (d), the two flaps of film 3 are heat sealed together
at their peripheral portions at a temperature of about 170 to about 200°C except at
filling openings 35, 36 for a medicinal preparation and powder preparation to obtain
a plastic container body 1. The filling opening 35 may be sealed and the filling opening
36 only may be left unsealed.
[0067] Next as shown in FIG. 13, (e), two parallel weak seal portions 8a, 8b are formed
at an intermediate portion of the container body, with a space portion 9 provided
therebetween, at a heat sealing temperature of about 110 to about 130°C. To be suitable,
the weak seal portion 8b is 10 mm and the weak seal portion 8a is about 5 mm in width.
[0068] Consequently, upper and lower container portions 1A, 1B are formed as partitioned
by the weak seal portions 8a, 8b. The medicinal preparation 11 is subsequently filled
into the lower container portion 1B through the opening 36, and the two filling openings
35, 36 are thereafter sealed off as seen in FIG. 13, (f), followed by sterilization
with autoclave.
[0069] Next as seen in FIG. 13, (g), the sterilized body is externally dried, the portion
of the opening 35 is cut in an aseptic atmosphere to open the opening 35 again, and
clean air is applied to the interior of the upper container portion 1A through the
opening 35 for drying and cleaning.
[0070] Next as shown in FIG. 13, (h), the powder preparation 10 is filled into the upper
container portion 1A through the opening 35 under an aseptic condition, and the filling
opening 35 is thereafter sealed off.
[0071] Next as shown in FIG. 13, (i), a cover 5 is provided to enclose the upper container
portion 1A therewith using two sheets of special film 6 shown in FIG. 5. Preferably
one of the two film sheets is transparent, and the other sheet is nontransparent.
[0072] To render the filled preparation 10 substantially free from heat when the film 6
is heat sealed to the edge of the upper container portion 1A, it is preferable to
provide a spacing of about 5 mm between the sealed joint 6b of the film 6 and the
chamber 1a in the upper container portion 1A. For this purpose, the joint 1A
1 (see FIG. 13, (h)) of the periphery of the upper container portion 1A, especially
at opposite side portions thereof, needs to have a width greater than 5 mm. Usually
this width is about 7 to about 10 mm in view of the sealing width of the film 6.
[0073] As shown in FIG. 4, the lower edge portion 6c of the cover 5 is sealed at the position
of the space portion 9 between the two weak seal portions 8a, 8b. The sealing temperature
is about 150 to about 170°C when the film 6 used is transparent, or 130 to 150°C when
the film used is a nontransparent aluminum-covered film.
[0074] As seen in FIG. 13, (i), the cover 5 provided around the upper container portion
1A is initially partly open at one side thereof as indicated at 40. An inert gas or
dry gas is injected into the space 7 between the cover 5 and the upper container portion
1A through the opening 40, and the opening 40 is thereafter sealed off. FIG. 13, (j)
shows the container of the invention having the two chambers and two weak seal portions
thus obtained. With the foregoing embodiment, the heat sealing temperature for forming
each joint is selectively set to an optimum temperature range in accordance with the
material of the film concerned and the contemplated seal strength. Accordingly, the
sealing temperature ranges given above are in no way limitative.
1. A container having a plurality of chambers (1A,1B) for accommodating a liquid, powder
or solid preparation (10,11) and partition means dividing the container into the chambers
and permitting communication between the chambers when required, the container comprising
a flexible body (1) made of plastics and having container portions which form said
plurality of chambers (1A,1B), at least one (1A) but not all of said chambers (1A,
1B) being enclosed within a cover (5) made of a flexible film (6) having moisture-
and gas-barrier properties to form a closed space (7) around said covered chamber(s)
(1A), said closed space (7) containing an inert gas and/or dry gas but not accommodating
a desiccant and/or an oxygen absorber, the other chamber(s) (1B) being coverless.
2. A container as defined in claim 1 wherein the partition means is formed by at least
one weak seal portion (8a,8b) easily openable by pressing the chamber (1A, 1B) to
give an increased internal pressure.
3. A container as defined in claim 2 wherein at least two weak seal portions (8a,8b)
are provided at a spacing (9), and the cover (5) has a heat-sealed edge (6c) between
the adjacent weak seal portions.
4. A container as defined in claim 1 wherein the covered chamber (1A) has accommodated
therein a liquid, powder or solid preparation (10,11) susceptible to oxidation and/or
hygroscopic.
5. A container as defined in claim 1 wherein the weak seal portion or portions (8a,8b)
are formed by directly heat-sealing together opposed inner surfaces of a flexible
plastics film (3) forming the container body (1).
6. A container as defined in claim 1 wherein the weak seal portion or portions (8a,8b)
are formed by heat-sealing together opposed inner surfaces of a flexible plastics
film (3) forming the container body (1), with an insert film held between the opposed
inner surfaces.
7. A container as defined in claim 1 wherein the container body (1) is formed of a flexible
plastics film (35) comprising an outer layer (31) of linear low-density polyethylene,
an intermediate layer (33) of resin mixture of linear low-density polyethylene and
ethylene/α-olefin elastomer, and an inner layer (34) of resin mixture of linear low-density
polyethylene and polypropylene.
8. A container as defined in claim 1 wherein the cover (5) comprises a layer of silica-deposited
resin film.
9. A container as defined in claim 1 wherein the cover (5) comprises an outer layer (43)
of biaxially oriented polyethylene terephthalate film, an intermediate layer (44)
of silica-deposited polyvinyl alcohol film, and an inner layer (45) of low-density
polyethylene.
10. A container as defined in claim 1 wherein the cover (5) has an outer surface provided
by an aluminum-laminated film.
11. A container as defined in claim 4 wherein the substance (10,11) susceptible to oxidation
and/or hygroscopic is an antibiotic.
1. Behälter mit einer Mehrzahl von Kammern (1A, 1B) zur Unterbringung eines flüssigen,
pulverförmigen oder festen Präparats (10,11) und einer Unterteilungseinrichtung, welche
den Behälter in Kammern unterteilt und eine Verbindung zwischen den Kammern gestattet,
wenn es erforderlich ist, wobei der Behälter einen biegsamen Körper (1) umfaßt, der
aus Kunststoff hergestellt ist und Behälterteile aufweist, welche die Mehrzahl von
Kammern (1A,1B) bilden, wobei mindestens eine (1A), aber nicht alle, der Kammern (1A,1B)
in einer Umhüllung (5) aus einer biegsamen Folie (6) mit Feuchtigkeits- und Gassperrschicht-Eigenschaften
eingeschlossen ist, um einen geschlossenen Raum (7) um die umhüllte(n) Kammer(n) (1A)
zu bilden, wobei der geschlossene Raum (7) ein Inertgas und/oder trockenes Gas enthält,
aber kein Trocknungsmittel und/oder Sauerstoff-Absorptionsmittel beherbergt, wobei
die andere(n) Kammer(n) (1B) ohne Umhüllung ist (sind).
2. Behälter nach Anspruch 1, in welchem die Unterteilungseinrichtung durch mindestens
einen Abschnitt mit schwacher Schweißnaht (8a,8b) gebildet ist, der leicht durch Drücken
der Kammer (1A, 1B), um einen erhöhten Innendruck zu ergeben, zu öffnen ist.
3. Behälter nach Anspruch 2, in welchem mindestens zwei Abschnitte mit schwacher Schweißnaht
(8a,8b) in einem Abstand (9) vorgesehen sind und die Umhüllung (5) einen wärmeverschweißten
Rand (6c) zwischen den benachbarten Abschnitten mit schwacher Schweißnaht aufweist.
4. Behälter nach Anspruch 1, in welchem die umhüllte Kammer (1A) darin untergebracht
ein flüssiges, pulverförmiges oder festes Präparat (10,11), das für eine Oxidation
anfällig und/oder hygroskopisch ist, aufweist.
5. Behälter nach Anspruch 1, in welchem der Abschnitt oder die Abschnitte mit schwacher
Schweißnaht (8a,8b) gebildet werden, indem man gegenüberliegende innere Oberflächen
einer biegsamen Kunststoffolie (3), welche den Behälterkörper (1) bildet, direkt miteinander
verschweißt.
6. Behälter nach Anspruch 1, in welchem der Abschnitt oder die Abschnitte mit schwacher
Schweißnaht (8a,8b) gebildet werden, indem man gegenüberliegende innere Oberflächen
einer biegsamen Kunststoffolie (3), welche den Behälterkörper (1) bildet, miteinander
verschweißt, wobei eine Einsatzfolie zwischen den gegenüberliegenden inneren Oberflächen
gehalten wird.
7. Behälter nach Anspruch 1, in welchem der Behälterkörper (1) aus einer biegsamen Kunststoffolie
(35) gebildet ist, welche eine äußere Schicht (31) aus linearem Polyethylen mit niedriger
Dichte, eine Zwischenschicht (33) aus einer Harzmischung von linearem Polyethylen
mit niedriger Dichte und Ethylen/α-Olefin-Elastomer und eine innere Schicht (34) aus
einer Harzmischung von linearem Polyethylen mit niedriger Dichte und Polypropylen
umfaßt.
8. Behälter nach Anspruch 1, in welchem die Umhüllung (5) eine Schicht aus einem Harzfilm
mit abgeschiedenem Siliciumdioxid umfaßt.
9. Behälter nach Anspruch 1, in welchem die Umhüllung (5) eine äußere Schicht (43) aus
biaxial orientierter Polyethylenterephthalat-Folie, eine Zwischenschicht (44) aus
Polyvinylalkohol-Folie mit abgeschiedenem Siliciumdioxid und eine innere Schicht (45)
aus Polyethylen mit niedriger Dichte umfaßt.
10. Behälter nach Anspruch 1, in welchem die Umhüllung (5) eine äußere Oberfläche aufweist,
die durch eine mit Aluminium laminierte Folie bereitgestellt wird.
11. Behälter nach Anspruch 4, in welchem die Substanz (10,11), die für eine Oxidation
anfällig und/oder hygroskopisch ist, ein Antibiotikum ist.
1. Récipient comprenant une pluralité de chambres (1A,1B)pour recevoir une préparation
liquide, en poudre ou solide (10,11) et des moyens de séparation divisant le récipient
en lesdites chambres et permettant une communication entre les chambres lorsque c'est
nécessaire, la poche comprenant un corps souple (1) enmatière plastique et ayant des
parties de récipient qui définissent ladite pluralité de chambres (1A,1B), au moins
une chambre (1A) mais non toutes lesdites chambres (1A,1B) étant enfermée à l'intérieur
d'une enveloppe (5) fabriquée en un film souple (6) ayant des propriétés d'arrêt de
l'humidité et des gaz de manière a définir un espace fermé (7) autour de la chambre
ou des chambres enveloppées (1A), ledit espace fermé (7) contenant un gaz inerte et/ou
un gaz sec mais ne contenant pas un produit dessicateur et/ou un produit d'absorption
de l'oxygène, la ou les autres chambres (1B) étant sans enveloppe.
2. Récipient selon la revendication 1,dans lequel les moyens de séparation sont constitués
par au moins une partie de jonction faible (8a,8b) qui peut être facilement ouverte
par compression de la chambre (1A,1B)pour engendrer une plus grande pression intérieure.
3. Récipient selon la revendication 2, dans lequel au moins deux parties de jonction
faible (8a,8b) sont prévues à un certain espacement (9), et l'enveloppe (5) comporte
un bord thermosoudé (6c) entre les parties de jonction faible adjacentes.
4. Récipient selon la revendication 1, dans lequel la chambre enveloppée (1A) contient
une préparation liquide, en poudre ou solide (10,11) sensible a l'oxydation et/ou
hygroscopique.
5. Récipient selon la revendication 1, dans lequel la ou les parties de jonction faible
(8a,8b) sont formées par thermosoudage direct mutuel des surfaces intérieures opposées
d'un film de matière plastique souple (3) formant le corps de récipient (1).
6. Récipient selon la revendication 1, dans lequel la ou les parties de jonction faible
(8a,8b) sont formées par thermosoudage mutuel des surfaces intérieures opposées d'un
film en matière plastique souple (3) formant le corps de récipient (1), avec un insert
de film tenu entre les surfaces intérieures opposées.
7. Récipient selon la revendication 1, dans lequel le corps de récipient (1) est formé
d'un film en matière plastique (35) comprenant une couche extérieure (31) de polyéthylène
linéaire basse densité, une couche intermédiaire (33) de mélange de résine de polyéthylène
linéaire basse densité et d'élastomère de type éthylène /α-oléfine, et une couche
intérieure (34) de mélange de résine de polyéthylène linéaire basse densité et de
polypropylène.
8. Récipient selon la revendication 1, dans lequel l'enveloppe (5) comprend une couche
de film de résine à dépôt de silice.
9. Récipient selon la revendication 1, dans lequel l'enveloppe (5) comprend une couche
extérieure (43) de film de téréphtalate de polyéthylène biaxialement orienté, une
couche intermédiaire (44) de film d'alcool polyvinylique à dépôt de silice et une
couche intérieure (45) de polyéthylène basse densité.
10. Récipient selon la revendication 1, dans lequel l'enveloppe (5) présente une surface
extérieure cosntituée par un film à couche d'aluminium.
11. Récipient selon la revendication 4, dans lequel la substance (10,11) sensible à l'oxydation
et/ou hygroscopique est un antibiotique.