Takeda Chemical Industries, Inc.

Minoru Yoshioka

Yohko Akiyama

Hidetoshi Horibe

Naoki Nagahara

Nobuyuki Kitamori

Toshio Kashihara

There is provided a matrix preparation produced by dispersing a pharmaceutically active ingredient into a matrix which is solid at ambient temperature and comprised of a fatty acid ester of a polyglycerol. The preparation has stable release-controlling ability, can be processed to fine granules, granules, capsules, tablets etc., and contributes to reduce the administration times of the active ingredient and side effects of the ingredient.

Sustained release preparations

Granulated preparations are provided by causing a granular, preferably spherical polyglycerol fatty acid ester having a melting poing of 40.degree.-80.degree. C. together with a powder for fluidized bed formation and heating the resulting fluidized mixture at a temperature in the vicinity of the melting point of the polyglycerol fatty acid ester. The powder may be contain as least one pharmacologically active ingredient. The polyglycerol fatty acid ester shows no crystal polymorphism and does not inactivate the pharmacologically active ingredient. Furthermore, the dissolution and release of the pharmacologically active ingredient can be controlled by varying the HLB of the polyglycerol fatty acid ester.

Granulated preparations and method of producing the same

There is provided a matrix preparation produced by dispersing a pharmaceutically active ingredient into a matrix which is solid at ambient temperature and comprised of a fatty acid ester of a polyglycerol. The preparation has stable release controlling ability, can be processed to fine granules, granules, capsules, tablets etc., and contributes to reduction of the administration times of the active ingredient and side effects of the ingredient.

Disclosed are (1) a stabilized FGF protein composition which comprises an FGF protein and water-insoluble hydroxypropyl cellulose; (2) a method for preparing a stabilized FGF protein composition, which comprises admixing an FGF protein with a water-insoluble hydroxypropyl cellulose; and (3) a method for stabilizing an FGF protein which comprises admixing an FGF protein with a water-insoluble hydroxypropyl cellulose, whereby the stabilized FGF protein can be provided. The composition is obtained in a solid state which has improved stability.

Stabilized FGF composition and production thereof

Fatty acid esters of polyglycerols, such as stearic acid penta(tetra)glyceryl ester, behenic acid hexa(tetra)glyceryl ester, lauric acid mono(deca)glyceryl ester, oleic acid di(tri)glyceryl ester, linolic acid di(hepta)glyceryl ester, palmitic acid deca(deca)glyceryl ester, etc. are employed as coating agents for coating solid preparations such as tablets, pills, granules, fine granules, etc. By coating with the coating agents, stable sustained release of active ingredients contained in the preparations is obtained, even after a long period of storage.

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Suita, Japan

Minoru Yoshioka