Stock material or miscellaneous articles – Hollow or container type article – Polymer or resin containing
Reexamination Certificate
2002-03-27
2004-08-17
Pyon, Harold (Department: 1772)
Stock material or miscellaneous articles
Hollow or container type article
Polymer or resin containing
C428S036700, C428S035700, C428S036900, C428S036910, C428S036920, C206S438000, C206S524100, C422S041000, C514S021800
Reexamination Certificate
active
06777052
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a plastic container containing an albumin solution. In particular, the present invention relates to a plastic container that allows evaporation of moisture only in an extremely small amount and is capable of storage of the solution for a long period of time.
BACKGROUND ART
Albumin, especially human serum albumin, is a protein which is present in plasma, and which is produced in the liver and has functions of maintaining normal oncotic pressure in blood flow and carrying nutritive substances or metabolites by combining therewith. For this reason, albumin has been considered to be effective in treating injury-related symptoms of patients suffering from hemorrhagic shock, thermal burns and the like and in treating patients suffering from hypoalbuminemia and fetal erythroblastosis. Conventionally albumin has been produced by fractionating blood collected from humans. Further, in recent years, research and development in large-scale production and purification technology of gene recombinant albumin have progressed, and as a result, pharmaceutical preparations for clinical treatment are going to be put on the market. Such albumin is dissolved in purified water to prepare a solution and is administered to a human by injection or clinical infusion.
As a container for receiving an albumin solution, a glass container has heretofore been used. For example, storage in a soft glass container subjected to a dealkalization treatment has been proposed (Japanese Patent Application Laid-open No. Hei 4-210648). Also, it has been proposed to store a human albumin solution in a type II glass vial, for example, silicate glass subjected to a standard surface treatment (treatment with ammonium salt or sulfur oxide, type II glass) (Japanese Patent Application Laid-open No. Hei 9-221431). These glass containers are each intended to avoid release of aluminum therefrom. However, these glass containers have defects in that they are heavy, likely to be destroyed, and the like. Further, a method of injecting these albumin solutions into glass containers has a danger of contamination of the albumin solution in the container with bacteria or other contaminants in the air, and thus such containers are not for general-purpose use.
For use in case of emergency, a lighter container than such glass containers is required. In response to this requirement, use of a plastic container has been studied in recent years. However, the present inventors have found that plastic containers have problems in that albumin is adsorbed on walls of the containers depending on the material thereof, water in the albumin solution evaporates while being stored in the container, and the containers are influenced by gas from the outside coming through the walls of the container such as oxygen, carbon dioxide gas and the like, and are also influenced by light from the outside of the container and so forth. On the other hand, as a pharmaceutical preparation, albumin preparations are required to have little change in quantity of water during storage.
SUMMARY OF INVENTION
The present inventors have made an intensive study in order to solve the above problems. As a result, the present inventors found that by controlling the surface area, wall thickness and plastic material of an albumin container so as to provide a moisture permeability (equivalent to water vapor permeability) and an oxygen permeability within specified ranges at 25° C. and relative humidity of 60%, an albumin container can maintain its performance over a long term, for example, for 800 days or more, thus attaining the present invention.
Therefore, the present invention relates to:
(1) a plastic container containing an albumin solution which has an albumin concentration of 1 to 500 mg/ml, wherein the container has at least one inlet/outlet for liquid, and has a low water vapor permeability of 1.5 g/m
2
/day·1013.25 hPa or less, when the water vapor permeability is measured at a pressure of 1013.25 hPa per surface area of 1 m
2
for 24 hours at 25° C. and at a relative humidity of 60%,
(2) a plastic container containing an albumin solution according to the above item 1, wherein the container has a low oxygen permeability of less than 5,000 cm
3
/m
2
/day·1013.25 hPa, when the oxygen permeability is measured at a pressure of 1013.25 hPa per surface area of 1 m
2
for 24 hours at 25° C. and at a relative humidity of 60%,
(3) A plastic container containing an albumin solution according to the above item 1, wherein the container is a single layer or multi layer structure,
(4) a plastic container containing an albumin solution according to the above item 1, wherein the container is a single layer structure,
(5) a plastic container containing an albumin solution according to the above item 1, wherein the plastic of the plastic container having low water vapor permeability is one or more members selected from the group consisting of polyethylene, polypropylene, polyvinyl chloride, crosslinked ethylene/vinyl acetate copolymer, polyvinylidene chloride, polybutene, polyester and ethylene copolymer,
(6) a plastic container containing an albumin solution according to the above item 1, wherein the plastic of the plastic container having low water vapor permeability is polyethylene or polypropylene,
(7) a packaged plastic container containing an albumin solution, wherein the plastic container containing an albumin solution of the above item 1 is packaged with an outer packaging,
(8) a packaged plastic container containing an albumin solution according to the above item 7, wherein the outer packaging has a low oxygen permeability of less than 5,000 cm
3
/m
2
/day·1013.25 hPa, when the oxygen permeability is measured at a pressure of 1013.25 hPa per surface area of 1 m
2
for 24 hours at 25° C. and at a relative humidity of 60%,
(9) a packaged plastic container containing an albumin solution according to the above item 7, wherein the outer packaging material is one or more members selected from the group consisting of ethylene/vinyl alcohol copolymer, polyvinylidene chloride, polyacrylonitrile, polyvinyl alcohol, polyamide, polyester, acrylonitrile copolymer, polyacrylonitrile, polyethylene terephthalate, polyamide copolymer, polyvinyl chloride, polyester copolymer, and vinylidene chloride copolymer,
(10) a packaged plastic container containing an albumin solution according to the above item 7, wherein the outer packaging material is ethylene-vinyl alcohol copolymer or polyvinyl alcohol,
(11) a packaged plastic container containing an albumin solution according to the above item 7, wherein a disoxidant is placed in the space between the plastic container and the outer packaging,
(12) a packaged plastic container containing an albumin solution according to the above item 7, wherein the plastic container is packaged with the outer packaging under vacuum,
(13) a packaged plastic container containing an albumin solution according to the above item 7, wherein the plastic container is packaged with the outer packaging under nitrogen gas, and
(14) a packaged plastic container containing an albumin solution according to the above item 7, wherein the plastic container is packaged with the outer packaging under light shielding conditions.
Also, the present invention relates to:
(15) a plastic container containing an albumin solution according to the above item 1, wherein the container comprises a multi-layer plastic material having an inner layer, an outer layer and optionally an intermediate layer, at least one of which provides a low water vapor permeability of 1.5 g/m
2
/day·1013.25 hPa or less (moisture permeability of 6.25×10
−3
mg/cm
2
/hour or less at 25° C. and at humidity of 60%), when the water vapor permeability is measured at a pressure of 1013.25 hPa per surface area of 1 m
2
for 24 hours at 25° C. and at a relative humidity of 60%,
(16) a plastic container containing an albumin solution according to the above item 15, wherein the plastic container comprises a multi-layer plastic material having an inner layer, an outer layer
Kai Toshiya
Murata Hideaki
Sato Makoto
Kubovcik & Kubovcik
Miggins Michael C.
Nipro Corporation
Pyon Harold
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