METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS

摘要

PROBLEM TO BE SOLVED: To provide methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans.SOLUTION: Methods for producing stabilized solid dosage form pharmaceutical compositions are provided. Specifically, methods for preparing protected granules containing morphinans, and solid dosage form pharmaceutical compositions produced using the morphinan-protected granules are provided. Another aspect of this disclosure provides granules that are substantially resistant to oxidative degradation of hydrocodone. The granules include an internal region that substantially contains hydrocodone and is surrounded by an external region that substantially contains at least one additive. The granules contain less than about 0.5% w/w, based on the total mass of hydrocodone, of a degradant selected from hydrocodone n-oxide and hydrocodone aldol dimer after being stored for 6 months at 40°C and 75% relative humidity.