Pancreatin micropellets prepared with polyethylene glycol 4000, paraffin and a lower alcohol by extrusion and rounding

US5378462A · kind A · utility

Assignee

• Kali-Chemie Pharma GmbH · DE

Inventors

• Bernd Boedecker · Hannover, DE
• Friederike Henninges · Braunschweig, DE
• Klaus-Juergen Koelln · Rothenfels, DE
• Guenther Kuhnow · Rothenfels, DE
• Guenter Peschke · Mering, DE
• Manfred Rehburg · Wagenfeld, DE
• Alwin Sobe · Sarstedt, DE
• Berthold Stemmle · Burgdorf, DE

Key dates

• Filing date: Aug 19, 1993
• Grant date: Jan 3, 1995
• Expiry date: Aug 19, 2013

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K9/5042
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

Pancreatin-containing micropellet cores which can be coated with a gastric juice-resistant film are prepared by extruding a mixture containing pancreatin, polyethylene glycol 4000 and a lower alcohol such as propan-2-ol to produce extrudates which break by themselves into fragments, rounding the fragments with the addition of highly liquid paraffin and drying. Propan-2-ol may be present with the paraffin during rounding. The micropellet cores contain 65-85% pancreatin, and have a bulk density of 0.6 g/ml to 0.85 g/ml, a spherical to ellipsoidal shape with a minor axis in the range of 0.7-1.4 mm and a particle size distribution in which at least 80% of the micropellet cores have a minor axis to major axis ratio in the range from 1:1 to 1:2.