Yamanouchi Pharmaceutical Company Ltd.

Astellas Pharma Gmbh

Katsuhiro Masaki

Akio Sugihara

Takehiko Yasuji

Daisuke Murayama

Kazutoshi Ban

A solid pharmaceutical preparation of solifenacin or a salt thereof, the preparation being stable and inhibited from decomposing with time when supplied to clinical fields. In a pharmaceutical preparation containing solifenacin or a salt thereof, the compound in an amorphous form was revealed to be causative of cardinal-drug decomposition with time. The composition for a solid pharmaceutical preparation of solifenacin or a salt thereof contains solifenacin or its salt each in a crystalline from, and the content provided are: a process for producing the composition; and a medicinal composition for solid pharmaceutical preparations which contains solifenacin and an amorphization inhibitor.

Composition of solifenacin or salt thereof for use in solid formulation

This invention is aimed to provide a stabilized formulation of ramosetron or a pharmaceutically acceptable salt thereof under a temperature/humidity condition, especially at a low content and relates to a stable oral solid drug composition of ramosetron or a pharmaceutically acceptable salt thereof, which is characterized by containing one or two or more members selected from the group consisting of an aliphatic carboxylic acid or an ester thereof, a hydroxycarboxylic acid or an ester thereof, an acidic amino acid, an enolic acid, an aromatic carboxyl compound or an ester thereof, and a carboxyl group-containing high-molecular substance, and to a stabilization method of the same. Also, this invention relates to a therapeutic agent of diarrhea-predominant irritable bowel syndrome containing from 0.002 to 0.02 mg of ramosetron hydrochloride as a daily dose or an equivalent molar amount of ramosetron or its pharmaceutically acceptable other salt as an active ingredient.

Stable oral solid drug composition

Intrabuccally disintegrating preparation and production thereof

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Yaizu, Japan

Katsuhiro Masaki