Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising neutral vinyl polymers and excipients

US9730899B2 · 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: Mar 18, 2009
• Grant date: Aug 15, 2017
• Expiry date: Feb 6, 2032

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61P29/00
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

The invention relates to a controlled release pharmaceutical composition, comprising a core, comprising a pharmaceutical active ingredient, whereby the core is coated by an ethanol resistance conferring coating layer which has the effect of conferring the release profile of the pharmaceutical active ingredient to be resistant against the influence of ethanol, whereby the ethanol resistance conferring coating layer comprises at least 70% by weight of a mixture of a polymeric portion a) and an excipients portion b), with the polymeric portion a) is consisting of a water insoluble essentially neutral vinyl polymer or vinyl copolymer and the excipients portion b) is consisting of the excipients b1) 100 to 250% by weight of a non-porous inert lubricant, b2) 1 to 35% by weight of a cellulosic compound, b3) 0.1 to 25% by weight of an emulsifier and additionally or alternatively to b3), b4) 0.1 to 30% by weight of a plasticizer whereby the excipients of the excipients portion b) are each calculated on the dry weight of the polymer portion a).