Importance

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Abstract

The present invention relates to a process for producing a sustained-release preparation comprising removing a solvent from an organic solvent solution containing a poorly water-soluble nonpeptidic physiologically active compound, a polyvalent metal compound and a biodegradable polymer, said physiologically active compound dissolved in an amount exceeding the solubility thereof in the organic solvent solution of biodegradable polymer in the absence of the polyvalent metal compound; a sustained-release preparation obtained by the process; a sustained-release solid pharmaceutical composition comprising a nonpeptidic physiologically active substance and a biodegradable polymer, wherein about 0.05% by weight or more, based on the weight of the composition, of a polyvalent metal is present on the surface of the composition; etc. In the sustained-release preparation, the poorly water-soluble nonpeptidic physiologically active compound is uniformly distributed and the sustained-release effect of the poorly water-soluble nonpeptidic physiologically active compound can be stably achieved. Moreover, a pharmaceutical composition comprising a nonpeptidic physiologically active substance wherein the initial burst release-of the physiologically active substance is efficiently controlled, a process for producing the same, etc. are provided.

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First Claim