HYDROMORPHONE HYDROCHLORIDE-CONTAINING ORAL SUSTAINED-RELEASE PHARMACEUTICAL COMPOSITION

摘要

The present invention addresses the problem of providing a hydromorphone hydrochloride- or oxycodone hydrochloride hydrate-containing orally-administered sustained-release pharmaceutical composition, which exhibits a reliable main pharmacological effect and has excellent formulation stability for avoiding excessive release of the principal agent, such as alcohol resistance. A sustained-release pharmaceutical composition containing (A) hydromorphone hydrochloride or oxycodone hydrochloride hydrate, (B) hydroxypropyl methyl cellulose acetate succinate having a median diameter (D50) of 40 µm or less, (C) hydroxypropylcellulose, and (D) a sugar; the weight ratio (C)/(B) of the (B) component and (C) component contained in the composition being 11/3 to 3/11.