ORAL PHARMACEUTICAL DOSAGE FORM HAVING RESISTIVITY TO UNAUTHORIZED ALTERATION CONTAINING OPIOID ANALGESIC

摘要

PROBLEM TO BE SOLVED: To provide a method of preparing a sustained-release oral agent having resistivity to unauthorized alteration which includes active drugs, such as opioid analgesic.SOLUTION: There is provided a method of preparing a sustained-release oral agent which at least includes the steps of: (a) forming a composition by combining (1) at least one type of polyethylene oxide having at least 1,000,000 of rough molecular weight based on rheology measurement and (2) at least one type of active drugs; (b) molding the composition to form a sustained-release matrix preparation; and (c) hardening the sustained-release matrix preparation which includes at least a hardening step in which the sustained-release matrix preparation is exposed to temperature being softening temperature of the polyethylene oxide at the lowest for at least about 1 minute.