Eisai Company, Limited

Eisai R&d Management Co., Ltd.

Shigeru Aoki

Takashi Kato

Yasuyuki Suzuki

Sumio Watanabe

Masanori Kayano

Koji Ukai

Yukiko Sugaya

Satoshi Fujioka

Noritoshi Koyama

Masayoshi Kasai

Shigeru Sakashita

Keizo Uesugi

Makoto Yokoyama

Yasuharu Saeki

Masao Kawamura

Mitsuru Mizuno

Akira Kato

Masaki Ichikawa

The present invention provides a method for stabilizing an oral solid formulation containing a benzimidazole-based compound or a physiologically acceptable salt thereof. That is, it provides a method for stabilizing a benzimidazole-based compound or a physiologically acceptable salt thereof, comprising incorporating 1) a crospovidone or a crospovidone and 2) sodium hydroxide and/or potassium hydroxide to a benzimidazole-based compound or a physiologically acceptable salt thereof.

Methods for stabilizing benzimidazole compounds

A peroral preparation of an acid-unstable compound comprises (1) a core containing the acid-unstable compound, (2) a first layer, coated on the core, comprising a hardly water-soluble, film-forming material and fine particles of a hardly water-soluble substance, suspended in the material, and (3) a second layer, coated on the first layer, of enteric film. The acid-unstable compound is a benzimidazole compound.

Peroral preparation of acid-unstable compound

A multi-layered granule comprises an inner, slow-releasing layer, an outer, rapid-releasing layer and an intermediate layer provided between said slow-releasing layer and said rapid-releasing layer which intermediate layer comprises a hardened oil and hydroxypropyl cellulose or methyl cellulose.

Multi-layer granule

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Gifu, Japan

Shigeru Aoki