Fujisawa Pharmaceutical Company, Ltd.

Astellas Pharma Gmbh

Rinta Ibuki

Takashi Saitoh

Satoshi Ueda

Fumio Shimojo

Takeo Hirose

Shigeki Tamura

Yukihiro Nomura

Toshio Ideno

Kazunari Yamashita

Norio Ohnishi

Masayuki Yamanaka

Takehisa Hata

Eiji Hashimoto

Toshihiko Toyoda

Erika Yoshida

Yoshio Ueda

Sumihisa Kimura

Kazutake Kado

Hiroshi Ishikuro

Takeo Chayamachi 525 Hirose

A sustained-release formulation is provided comprising a solid dispersion composition comprising a tricyclic compound or a pharmaceutically acceptable salt thereof in a mixture comprising a water-soluble polymer and a water-insoluble polymer, and an excipient.

Sustained-release formulation

Sustained release formulation containing tacrolimus or its hydrate is provided. The time (T63.2%) required for 63.2% of the maximum amount of tacrolimus or its hydrate to be dissolved is 0.7 to 15 hours. The time is measured in accordance to the Japanes Pharmacopocia, the 13-th edition, Dissolution Test, No. 2 (Puddles method, 50 rpm) using an aqueous 0.005% hydroxypropyl cellulose solution. This aqueous test solution is adjusted to pH 4.5, accordingly. The formulation further comprises a solid base which is a water-soluble or water-insoluble polymer. The formulation is in the form of a powder, fine powder, granule, tablet or capsule. The formulation is administered to a patient once a day for preventing organ or tissue rejection by transplantation or autoimmune disease. In addition, a solid dispersion composition is provided. The solid dispersion comprises tacrolimus or its hydrate in a mixture containing water-soluble or water-insoluble polymer and an excipient.

Sustained release formulation containing tacrolimus

To provide a pharmaceutical composition comprising a macrolide compound, such as tricyclic compound (I) or its pharmaceutically acceptable salt, a dissolution/absorption promoter, a pharmaceutical base, and optionally a compatibilizing agent and/or a thickener. It is satisfactory in stability and absorption kinetics and/or a low irritation potential.

Medicinal compositions

Sustained release formulation containing tacrolimus or its hydrate is provided. The time (T63.2%) required for 63.2% of the maximum amount of tacrolimus or its hydrate to be dissolved is 0.7 to 15 hours. The time is measured in accordance to the Japanese Pharmacopoeia, the 13-th edition, Dissolution Test, No. 2 (Puddle method, 50 rpm) using an aqueous 0.005% hydroxypropyl cellulose solution. This aqueous test solution is adjusted to pH 4.5, accordingly. The formulation further comprise a solid base which is a water-soluble polymer and/or wax. The formulation is in the form of a powder, fine powder, granule, tablet or capsule. Furthermore, the formulation is administered to a patient once a day for preventing organ or tissue rejection by transplantation or autoimmune diseases.

Sustained release formulations containing tacrolimus

Providing an oral formulation of a macrolide compound where the dissolution of the macrolide compound is under sustained release; and a sustained-release formulation containing a composition in solid solution, where the macrolide compound is present at an amorphous state in a solid base.

Sustained release preparations

A pharmaceutical composition comprising a tricyclic compound (I) or its pharmaceutically acceptable salt, an oil substance, a surfactant, a hydrophilic substance, water, and optionally a pH control agent, with enhanced stability, absorbability and/or a low irritation potential, is provided.

Pharmaceutical composition

Provided is a medicinal composition having a very satisfactory drug release profile and a very satisfactory drug absorption profile after oral administration characterized by its comprising an insoluble drug and two or more surfactants, at least one of the surfactants having as dissolved therein the insoluble drug and the other surfactant or surfactants.

Two surfactant-containing medicinal composition

The present invention relates to a pharmaceutical composition for percutaneous drug absorption which comprises 5-isopropyl 3-methyl 2-cyano-6-methyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate, and ethanol and/or an unsaturated higher fatty acid and to a composition of matter which comprises ethanol and/or an unsaturated higher fatty acid and is capable of promoting percutaneous absorption of said dihydropyridine compound.

Pharmaceutical composition for percutaneous drug absorption and

A method for preparing stable crystals of a salt of Ceftizoxime which comprises mixing an aqueous solution of a salt of Ceftizoxime and isopropyl alcohol and collecting the precipitating crystals. Crystals obtained in this manner are more stable than the crystals obtained from prior art methods involving mixed solvents of water and ethanol.

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Kyoto, Japan

Rinta Ibuki