Process for producing spherical base granule comprising easily water-soluble drug
AssigneeAsahi Kasei Chemicals Corporation
InventorsYoshihito Yaginuma, Rika Matsumoto
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Abstract
Provided is a process for producing spherical base granules comprising a easily water-soluble drug and suited for film coating by spraying a layering liquid over pharmaceutically inert spherical core particles, thereby coating the particles with a layer comprising the easily water-soluble drug, wherein (1) the spherical core particles have a microcrystalline cellulose content of 30 mass % or greater and a water absorbing capacity of 0.5 cm3/g or greater; and (2) the layering liquid is an aqueous solution comprising at least the easily water-soluble drug and a low water-soluble saccharide.
Claims6
A process for producing spherical base granules comprising an easily water-soluble drug, which comprises spraying a layering liquid over pharmaceutically inert spherical core particles to thereby coat the particles with a drug-containing layer, wherein:
- (1) the spherical core particles have a microcrystalline cellulose content of 30 mass % or greater, a water absorbing capacity of 0.5 cm3/g or greater and a bulk density of about 0.5 to about 2.0 g/cm3;
- (2) the layering liquid is an aqueous solution comprising at least from 5 to 30 mass % of the easily water-soluble drug and from 1 to 30 mass % of D-mannitol;
- (3) the easily water-soluble drug has a solubility of 1.5 g or greater in 1 cm3 of water at 20° C;
- and
- (4) the easily water-soluble drug is at least one selected from the group consisting of ethyl L-cysteine hydrochloride, cloperastine hydrochloride, procainamide hydrochloride, ceftizoxime sodium, migrenin, and loxoprofen sodium.
Dependencies are inferred from the claim text.