PURPOSE: To obtain the title preparation to release a drug at controlled rate without being influenced by physiological factors of digestive tube in oral administration by coating granules containing polyanion particles existing as a discontinuous layer and a basic drug hydrochloride with a slightly water-soluble substance.
CONSTITUTION: Granules containing a basic drug hydrochloride and a polyanion, preferably carboxyvinyl polymer or carboxymethyl cellulose at the same time wherein polyanion particles exist as a discontinuous layer are coated with a film coating agent containing a slightly water-soluble substance (e.g. ethyl cellulose or aminoalkyl methacrylate copolymer). The granules to become nuclei preferably contain ≤50wt.% drug and 2-50wt.% polyanion and the coating film preferably contains ≥60wt.% slightly water-soluble substance. The preparation will not change of release rate of drug depending upon amount of digestive juice, properties thereof, amount and quality of meal and can minimize variability of concentration of drug in blood.
MITSUMIZO FUMIO
NOGUCHI TETSUO
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