Astellas Pharma Gmbh

Yamanouchi Pharmaceutical Company Ltd.

Takehiko Yasuji

Akio Sugihara

Katsuhiro Masaki

Daisuke Murayama

Kazuhiro Sako

Hiroyuki Yoshino

Noriyuki Kinoshita

Shuuya Kawahama

The present invention relates to a pharmaceutical composition for oral administration comprising a modified release portion containing tamsulosin or a pharmaceutically acceptable salt thereof, and an immediate release portion containing solifenacin or a pharmaceutically acceptable salt thereof and a hydrophilic substance. In the pharmaceutical composition, the dissolution rate of each drug (in particular, solifenacin contained in the immediate release portion) is similar to those of the current single drug formulations, and the maximum percentage of drag dissolution of each drug (in particular, solifenacin contained in the immediate release portion) is 90% or more. Therefore, the pharmaceutical composition is a single formulation (i.e., a combined formulation) with a bioavailability equivalent to those of the current single drug formulations.

Pharmaceutical composition for oral administration

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

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Tokyo, Japan

Takehiko Yasuji