Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol

A pH-dependent controlled release pharmaceutical composition, comprising

• a core, comprising at least one pharmaceutical active ingredient, which is an opioid, wherein the core is coated by at least one coating layer, controlling release of the pharmaceutical composition,
• wherein the at least one coating layer comprises:
• (A) a polymer mixture of
• (Ai) 40-95% by weight, based on a dry weight of the polymer mixture, of at least one water insoluble essentially neutral vinyl polymer or copolymer, and
• (Aii) 5-60% by weight, based on the dry weight of the polymer mixture, of at least one anionic polymer or copolymer, which is insoluble in a buffered medium below pH 4.0 and soluble at least in a pH range from 7.0 to 8.0;
• (B) 110 to 250% by weight of a non-porous inert lubricant;
• (C) 1 to 35% by weight of at least one neutral cellulosic compound;
• and
• (D) 1 to 25% by weight of at least one emulsifier,
• wherein (B) through (D) are calculated on the dry weight of the polymer mixture.