[Resistance and disintegration behavior of gastric juice-resistant drug products. 3. Pharmaceutical-technological and analytical studies of gastric juice-resistant commercial preparations].
Enteric coated commercial dosage forms often do not correspond with acid resistance and disintegration requirements of the Ph. Eur. About 15-20% of 181 tested samples disintegrate during acid resistance test or do not disintegrate in buffer solution pH = 6.8. The percentage was extremely high amongst enteric coated pancreatin or cardiac glycosides (about 30%) preparations. Storage conditions and time influence acid resistance and disintegration time. 80% of 34 products coated with celluloseacetate phthalate, hydroxypropylmethylcellulose phthalate or polymethacrylic acid ester did not change disintegration time after 2 years storage at 20 degrees C. After storage at 40 degrees C the number decreased to 40%. After 5 years at 20 degrees C number of products which were not stable increased.
Thoma
K
K
Institut für Pharmazie und Lebensmittelchemie, Ludwig-Maximilians-Universität München, BRD.
Heckenmüller
H
H
Oschmann
R
R
D002626:Chemistry, Pharmaceutical; D004304:Dosage Forms / Q000032:analysis*; D004355:Drug Stability; D004356:Drug Storage; D005750:Gastric Juice / Q000032:analysis*; D006863:Hydrogen-Ion Concentration; D012995:Solubility; D013608:Tablets, Enteric-Coated / Q000032:analysis*; D013678:Technology, Pharmaceutical; D013696:Temperature; D013997:Time Factors
D004304:Dosage Forms; D013608:Tablets, Enteric-Coated
Resistenz- und Zerfallsverhalten magensaftresistenter Fertigarzneimittel. 3. Mitteilung: Pharmazeutisch-technologische und analytische Untersuchungen an magensaftresisten ten Darreichungsformen.