Kali-Chemie Pharma Gmbh

Abbott Products Gmbh

Abbott Laboratories Corporation

Bernd Boedecker

Peter-Colin Gregory

Bernd Thumbeck

George Shlieout

Berthold Stemmle

Alwin Sobe

Siegfried Schaefer

Friederike Henninges

Klaus-Juergen Koelln

Guenther Kuhnow

Guenter-Josef Peschke

Manfred Rehburg

Dominique Baum

Gerhard-Wilhelm Bielenberg

Orally administrable pharmaceutical compositions of lipase-containing products, particularly pancreatin and pancreatin-containing products, or of enzyme products which contain at least one lipase of non-animal, especially microbial origin, which improve the lipolytic activity and particularly result in stabilization of the lipase in the acidic pH range. These oral pharmaceutical compositions contain a system which includes at least one surfactant and one co-surfactant and optionally a lipophilic phase, and are self-emulsifiable on contact with a hydrophilic and a lipophilic phase. The compositions according to the invention are suitable for treating or inhibiting maldigestion, especially maldigestion due to chronic exocrine pancreatic insufficiency, in mammals and humans.

Pharmaceutical compositions of lipase-containing products, in particular of pancreation

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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Hannover, Germany

Bernd Boedecker