EinfluÃ von Pankreatin auf die StabilitÃ¤t magensaftresistenter ÃberzÃ¼ge2. Mitteilung: LagerstabilitÃ¤t magensaftresistent-Ã¼berzogener Filmtabletten*)
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 /2nd Communication: Stability on storage of gastroresistant film-tablets
An assessment of the stability on storage of placebo and pancreatin film-coated tablets with identical coatings did not yield significant differentes in the coating agents examined. The only exceptions were the film-coated tablets stored at 25 Â°C and 70 % r.h. coated with an organic Solution of the cellulose acetate phthalate (CAP) coating agent and those coated with an aqueous dispersion of the Carboxy-methylethylcellulose (CMEC) coating agent. Unlike the Placebo tablets, the pancreatin tablets coated with CMEC showed reduced resistance after a storage period of only 6 months. After a storage period of 12 months, the pancreatin tablets with a CAP coat no longer disintegrate within 60 min as stipulated in the pharmacopoeia. Appling a barrier coat Prior to the enteric coating consisting of aqueous dispersion of the coating agent Hydroxypropyl methylcellulose phthalate (HPMCP) and CAP resulted in reduced swelling of the tablets coated with CAP An evaluation of the storage stability showed that disintegration time and swelling behaviour of the tablets, particularly those coated with an aqueous dispersion, was brought under control by the application of a barrier coat. All film-coated pancreatin tablets of pancreatin quality 2 proved to be unstable on storage. HPMCP was used as a coating agent in these tests. In a resistance test performed already after 6 months of storage the film-coated pancreatin tablets showed strong surface swelling as a function of the storage temperature. The corresponding tablets prepared from the residual 5 pancreatin qualities, however, only showed minor changes in resistance. The impact of pH on storage stability of the tablet cores can be exemplified by the Cellulose acetate trimellitate (CAT) film-coated tablets prepared with the organic and aqueous ammoniacal solution, respectively. At high pH values the instability of the coating agent increases more rapidly. With the CAT coating agent this results in a marked prolongation of the disintegration time.
Key words LagerstabilitÃ¤t Â· Magensaftresistenz Â· Pankreatin-QualitÃ¤t Â· ÃberzÃ¼ge, organische, wÃ¤Ãrige
Â© ECV- Editio Cantor Verlag (Germany) 1999
pharmind 1999, Nr. 2, Seite 184