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Einfluß von Pankreatin auf die Stabilität magensaftresistenter Überzüge

1. Mitteilung: Einfluß magensaftresistenter Filmüberzüge auf das Resistenz- und Zerfallsverhalten von Pankreatin-Filmtabletten

Karl Thoma und Thomas Kräutle

Institut für Pharmazie - Zentrum für Pharmaforschung, Lehrstuhl für Pharmazeutische Technologie, Ludwig-Maximilians-Universität München

Influence of Pancreatin on the Stability of Gastroresistant Coatings /1st Communication: Influence of gastroresistant Coatings on the Resistance and Disintegration

For gastroresistant coated pancreatin tablets different results on the resistance and disintegration behaviour are reported. The goal of the presented investigations has been to judge the reasons. The determination of acid permeability to gravimetry has proven to be a reproducible and simple method for assessing the coating quality of in-house film-coated tablets and commercial pancreatin tablets. Of the film-coated tablets coated with organic and aqueous dispersions those with a Methacrylic acid ethacrylate copolymers coat showed the least swelling (< 5 %), those with a Cellulose acetate trimellitate (CAT) coat the most massive swelling (20-65 %) in a 4-h resistance test. At the beginning of testing both the tablets with an organic coating and those with an aqueous coating met the pharmacopoeial requirements. Only those tablets coated with aqueous dispersions of the CAT and Cellulose acetate phthalate (CAP) coating agents showed massive swelling (38 and 24 %, respectively) when acid permeability was evaluated in a 2-h resistance test in 0,1 N hydrochloric acid.

Key words Eudragit · Magensaftresistenz · Pankreatin · Säurepermeabilität · Überzüge, organische und wäßrige · Zellulosederivate