Multi-particulate form of medicament, comprising at least two differently coated forms of pellet

US6897205B2 · kind B2 · utility

Assignee

• ROEHM GMBH & CO. KG · DE

Inventors

• Thomas Beckert · Darmstadt, DE
• Hans-Ulrich Petereit · Darmstadt, DE
• Jennifer Dressman · Paris, FR
• Markus Rudolph · Neu-Isenburg, DE

Key dates

• Filing date: Mar 9, 2001
• Grant date: May 24, 2005
• Expiry date: Mar 9, 2021

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K9/5073
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

The invention relates to a multiparticulate drug form suitable for uniform release of an active pharmaceutical ingredient in the small intestine and in the large intestine, comprising at least two forms of pellets A and B which comprise an active pharmaceutical ingredient in the core and have different polymer coatings which determine the release of the active ingredient at different pH values, characterized in that pellet form A is provided with an inner polymer coating which enables continuous release of active ingredient, and has an outer enteric coating which rapidly dissolves above about pH 5.5, and pellet form B is provided with a polymer coating which, in the USP release test, releases less than 20% of the active ingredient at pH 6.8 in 6 hours and releases more than 50% of the active ingredient at pH 7.2 in 6 hours. The invention additionally relates to a process for producing the multiparticulate drug form and to the use of pellet forms A and B for producing the drug form.