EinfluÃ von Pankreatin auf die StabilitÃ¤t magensaftresistenter ÃberzÃ¼ge3. Mitteilung: LagerstabilitÃ¤t magensaftresistent-Ã¼berzogener Pankreatin-Fertigarzneimittel* )
Karl Thoma und Thomas KrÃ¤utle
Institut fÃ¼r Pharmazie - Zentrum fÃ¼r Pharmaforschung, Lehrstuhl fÃ¼r Pharmazeutische Technologie, Ludwig-Maximilians-UniversitÃ¤t MÃ¼nchen
Influence of Pancreatin on the Stability of Gastroresistant Coatings / 3rd Communication: Stability on storage of gastroresistant pancreatin-products
The tests performed shortly after receipt from the manufacturer, 20 % of the 49 enteric coated commercial pancreatin products showed a reduction in resistance to gastric fluid in a 2-h resistance test in 0.1 N hydrochloric acid. 14 % of the products did not disintegrated before 1 hour in phosphate buffer pH 6.8. When these pancreatin products are stored at 25 Â°C, problems associated with resistance and disintegration increase as a function of the storage period. After a storage period of 3 years a loss of resistance is seen in 43 % of the products. If the number of tablets showing swelling of the tablet surface is added to this figure, the number of products in which resistance is reduced amounts to 70 %. The type of coating agent used has an impact on the behaviour of the pancreatin product. Products with a Cellulose acetate phthalate (CAP) coat or a combined CAP and a shellac coat primarily show very marked swelling of the tablet surface and a considerably prolonged disintegration time. Products with a poly(meth)acrylate coating are found to be highly stable on storage. A typical feature of Hydroxypropyl methylcellulose phthalate (HPMCP) coated products is a storage and temperature related loss of resistance. When stored at 20 Â°C, resistance problems only occur at a later point in time with some of these products.
Key words Magensaftresistente Filmbildner Â· Magensaftresistenz Â· Magensaftresistent-Ã¼berzogene Pankreatin-Fertigarzneimittel Â· LagerstabilitÃ¤t Â· Zerfallszeit
* ) 1. und 2. Mitteilung siehe Pharm. Ind. 61, Nr. 1, S. 79, und Nr. 2, S. 184 (1999).
pharmind 1999, Nr. 3, Seite 270