Stock material or miscellaneous articles – Coated or structually defined flake – particle – cell – strand,... – Rod – strand – filament or fiber
Patent
1997-06-05
1999-07-13
Nold, Charles
Stock material or miscellaneous articles
Coated or structually defined flake, particle, cell, strand,...
Rod, strand, filament or fiber
428 357, 428 345, 502 1, 206828, 206438, 2065244, 2065245, 206205, 2062131, 422 40, C09K 1504
Patent
active
059224614
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to a method for inhibiting adsorption of container-derived contaminants on drugs such as powdery drugs and to a container housing a drug in stable condition.
BACKGROUND OF THE INVENTION
Glass containers are mainly used for powdery or solid pharmaceutical preparations containing antibiotics, e.g. cefazolin, ampicillin, etc., or enzymes, e.g. urokinase etc., as active ingredients, while containers made of almite (aluminum with a surface oxide film), hard glass, stainless steel, or the like are used for accommodating the starting materials or synthetic intermediates of drugs and the so-called bulk substances.
However, containers made of such materials are disadvantageous in that the drugs contained are liable to become contaminated with metal or glass fragments upon unsealing.
Recently, containers made of glass (borosilicate glass, soda-lime glass) plus rubber, elastomeric closure or the like came into usage but they were also found to have the disadvantage that the antioxidant, e.g. 2,6-di-t-butyl-4-methylphenol (BHT), vulcanizer, adipic acid derivative, phthalic acid derivative, and other additives, as well as the lubricant oil, e.g. silicone oil, tend to emigrate from the rubber or elastomeric closure and become adsorbed on the drugs to cause insoluble particulate matter.
Research is also being done into the use of plastics for pharmaceutical containers, but polyvinyl chloride (PVC), for instance, has the drawback that additives such as dioctyl phthalate (DOP) contained may dissolve out into the interior of the container, while nylon, polyurethane, ethylene-vinyl acetate copolymer (EVA), etc. have the disadvantage that the residual unreacted monomer or monomers tend to prevent formation of a homogeneous solution of the powdery drug. Furthermore, while an adhesive is used in the manufacture of containers from nylon, polyurethane, etc., the solvent used in the adhesive, such as methyl ethyl ketone, toluene, or xylene, diffuse out and become adsorbed on the drug as it is the case with said unreacted monomers, thus causing decomposition, degradation, insoluble particulate matter, and other troubles inclusive of toxic interactions.
The feasibility of using polyolefins such as polyethylene and polypropylene is also being assessed by the industry and their usage for pharmaceutical containers is being spreading but these materials also have the disadvantage that the process-derived contaminants such as adipic acid or phthalic acid derivatives, oils, low molecular substances, the so called wax component, etc. tend to be adsorbed on the drug powder contained and when the drug powder is dissolved in a solvent such as water for injection, give rise to insoluble particulate matter.
Thus, each of the known materials for pharmaceutical containers has its own drawbacks and, therefore, a demand exists for a new method of overcoming said disadvantages and a new kind of drug container which is free from the disadvantages.
SUMMARY OF THE INVENTION
The object of the present invention, therefore, is to provide a method for providing an improved pharmaceutical container for powdery or other medicines and a novel improved container.
The inventors of the present invention did much research for accomplishing the above-mentioned object and discovered that when a lower alcohol vapor phase is established as the internal atmosphere of a container, the adsorption of potential contaminants derived from the container material, such as rubber or a plastic, on the drug substance is remarkably inhibited, with the result that the incidence of insoluble particulate matter (non-homogeneous dissolution) in a solution of the drug is completely precluded without any appreciable loss of the drug substance due to decomposition, degradation, or aging, without entailing any associated toxic reaction, and without detracting from the inherent solubility of the powdery drug, thus insuring a long-term stability and clinical safety of the drug.
The present invention has been brought into being based on t
REFERENCES:
patent: 4820442 (1989-04-01), Motoyama et al.
Hayashi Satoru
Inoue Fujio
Izumi Masamitsu
Yoshida Chieko
Nold Charles
Otsuka Pharmaceutical Factory Inc.
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