Multilayer pharmaceutical product for release in the colon

US6632454B2 · kind B2 · utility

Assignee

• ROEHM GMBH & CO. KG · DE

Inventors

• Thomas Beckert · Darmstadt, DE
• Hans-Ulrich Petereit · Darmstadt, DE
• Vishal Gupta · Portage, US

Key dates

• Filing date: Nov 19, 2001
• Grant date: Oct 14, 2003
• Expiry date: Nov 19, 2021

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K9/5026
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

The invention relates to the use of a multilayer pharmaceutical product that substantially comprises a) a core containing a pharmaceutically active substance, b) an inner coating consisting of a copolymer or a mixture of copolymers that are composed of 85 to 98 wt.- % of radically polymerized C1 to C4 alkyl esters of the acrylic or methacrylic acid and 15 to 2 wt.- % of (meth)acrylate monomers with a quaternary ammonium group in the alkyl group, and c) an outer coating consisting of a copolymer that is composed of 75 to 95 wt.- % of radically polymerized C1 to C4 alkyl esters of the acrylic or methacrylic acid and 5 to 25 wt.- % of (meth)acrylate monomers with an anionic group in the alkyl group. The inventive product is used for producing a pharmaceutical product that releases the active substance contained therein according to the USP release test, at pH 1.2 during 2 hours and subsequent rebuffering to pH 7.0, by less than 5% after 2.0 hours after start of the test and by 30 to 80% after eight hours after start of the test.