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

US9757343B2 · kind B2 · utility

Assignee

• Evonik Röhm GmbH · DE

Inventors

• Hans Bär · Michelstadt, DE
• Thomas Fürst · Schwieberdingen, DE
• Gerhard Renner · Deggendorf, DE
• Michael J. Gottschalk · Ober-Ramstadt, DE

Key dates

• Filing date: Sep 24, 2008
• Grant date: Sep 12, 2017
• Expiry date: Feb 22, 2032

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61P25/36
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

The invention relates to a pH-dependent controlled release pharmaceutical composition, comprising a core, and an opioid, wherein the core is coated at least by one coating layer, controlling the release of the pharmaceutical composition, wherein the coating layer comprises a polymer mixture of i) 40-95% by weight, based on dry weight of the polymer mixture, of at least one water insoluble essentially neutral vinyl polymer, and ii) 5-60% by weight, based on 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 the range from pH 7.0 to pH 8.0, characterized in that the coating layer further comprises 110 to 250% by weight of a non-porous inert lubricant, 1 to 35% by weight of a neutral cellulosic compound and 1 to 25% by weight of an emulsifier, each calculated on dry weight of the polymer mixture.