| abstract |
A method for producing a coated bioactive granule comprising a core granule containing a bioactive substance and a coating film covering the surface of the core, characterized by comprising a step of reducing the concentration of a volatile matters contained in the bioactive substance; and a method for producing the coated bioactive granule wherein the production conditions are controlled in a manner such that physical properties and/or functions of a coated bioactive granule produced (hereinafter referred to as “product data”) meet specifications of physical properties and/or functions of the coated bioactive granule (hereinafter referred to as “product specifications”), based on deviations between product data and product specifications, characterized in that it comprises a step of reducing the concentration of a volatile matters contained in the bioactive substance. The coated bioactive granule produced by the above method exhibits a significantly reduced change in the release function caused by the elapse of time during storage, and a product having predetermined properties and functions at the time of practical use can be obtained with stability even when production conditions are amended using product data obtained immediately after the production. |