Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Patent
1996-05-17
1997-11-18
Rollins, John W.
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
424 6, 424 43, 424 46, 424 47, 424490, 424491, 424492, 424493, 424494, 424495, 424496, 424497, 424498, 424483, 424484, 424485, 424486, 424487, 424488, 424489, A16K 3578, A16K 920, A16K 900, A16K 914
Patent
active
056885105
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to a process for producing physicochemically stable medicinal compositions.
BACKGROUND ART
Useful drugs are available for a variety of diseases but because of their inherent instability, certain drugs present the problem that they decompose during storage to cause discoloration of preparations or aggregation of granules by absorbing ambient moisture. Such objectionable events are frequently associated with heat, moisture, water, light, acids, bases, and/or air. It is generally thought that these factors are delicately involved in the unwelcome events mentioned above.
The conventional and common approach toward stabilizing any drug or preparation physically and chemically comprises identifying the instability factors involved and disposing of each of the factors. For sublimable drugs, a method comprising addition of a metal salt (German Patent 1034327, Japanese Patent Publication No.49-11219) or a method in which drugs are made amorphous (Japanese Patent Application Kokai S58-154547 and Japanese Patent Application Kokai S58-154548) is used. For drugs hydrolyzable in the presence of water, a method comprising addition of aluminum silicate and hydrolyzed starch and subsequent granulation-dehydration (Japanese Patent Kokai S60-89479) or a conventional coating method using a synthetic or natural film-forming polymer or a waxy substance. For drugs which would develop whiskers, a method comprising adding carbon, silicic anhydride and/or montmorillonite (Japanese Patent Publication No.56-37970), a method comprising adding an antacid (Japanese Patent Publication No. 2-85214), or a method in which granules containing a drug liable to develop whiskers and granules containing other substances are independently provided (Japanese Patent Publication No. 4-5234) is used. To overcome the inter-grain adhesion or dissolution of dosage forms associated with the hygroscopicity or deliquescence of drugs, a cyclodextrin clathrate method (Japanese Patent Application Kokai S 56-133236), a method employing an organic acid method comprising using an excipient having a high water absorption capacity (the Proceedings of the 105 Congress of Pharmaceutical Society of Japan, p. 740), among others, are known.
However, it is often time-consuming to locate the individual instability factors involved and disposing of each of them. Moreover, many of the solutions so far proposed are not satisfactory in practical applicability, cost, production efficiency, operating conditions required, and quality. Thus, the conventional remedies are not fully satisfactory for commercial application.
Meanwhile, a multi-screw extruder or a screw kneader-extruder is in broad use in the food and plastics industries and mainly for the processing of food (cereals, proteins, animal meat, fish meat, etc.).
As technologies utilizing a multi-screw extruder in the pharmaceutical field, a process for producing solid pharmaceutical preparations (Japanese Patent Application Kokai S62-242630), a process for producing solid dispersions (PCT WO92/18106), a process for producing a wax matrix (PCT WO94/08568), and the process disclosed in Japanese Patent Application Kokai H5-194197 are known. These technologies are designed for expedient and commercially profitable manufacture of preparations useful for increased bioavailability and/or controlled release and not directly relevant to a technology for stabilizing drug substances.
DISCLOSURE OF INVENTION
A great commercial advantage should be realized if drugs and preparations could be stabilized in one operation against a plurality of factors affecting the stability of such drugs and preparations.
The present invention, therefore, has for its primary object to provide a technology by which drugs and preparations can be stabilized both physically and chemically in a practically feasible, economical, and expedient manner.
Exploring into many potentials of a multi-screw extruder (hereinafter referred to briefly as "extruder") in the pharmaceutical field, the inventors of the pre
REFERENCES:
patent: 4764378 (1988-08-01), Keith et al.
patent: 4801460 (1989-01-01), Goertz et al.
Izumi Shougo
Nakamichi Kouichi
Yasuura Hiroyuki
Nippon Shinyaku Co. Ltd.
Rollins John W.
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