Kali-Chemie Pharma Gmbh

Manfred Rehburg

Berthold Stemmle

Alwin Sobe

Bernd Boedecker

Klaus-Juergen Koelln

Guenther Kuhnow

Friederike Henninges

Guenter-Josef Peschke

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.

Pancreatin micropellets prepared with polyethylene glycol 4000, paraffin

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Wagenfeld, Germany

Manfred Rehburg