[Effect of film formers and plasticizers on the stability of resistance and disintegration behavior. 4. Pharmaceutical-technological and analytical studies of gastric juice-resistant commercial preparations].
Chemical an physical properties of film coating materials determine stability of enteric coated pharmaceutical dosage forms. About 80% of commercial enteric coated drugs with coatings of celluloseacetate phthalate or polymethacrylic acid ester did not change acid resistance or disintegration time after 2 years, storage at 20 degrees C or 40 degrees C. Disintegration time of 4 drugs which are enteric coated with hydroxypropylmethylcellulose phthalate, decreased more often. Some of these did not fulfill acid resistance requirements of the Ph. Eur., tests which show influence of softeners to stability of enteric coatings have to be extended.
Thoma
K
K
Institut für Pharmazie und Lebensmittelchemie, Ludwig-Maximilians-Universität München, BRD.
Heckenmüller
H
H
D002482:Cellulose / Q000031:analogs & derivatives; D002626:Chemistry, Pharmaceutical; D004304:Dosage Forms / Q000032:analysis*; D004355:Drug Stability; D005750:Gastric Juice / Q000032:analysis*; D008747:Methylcellulose / Q000031:analogs & derivatives; D010968:Plasticizers; D011109:Polymethacrylic Acids; D012995:Solubility; D013608:Tablets, Enteric-Coated / Q000032:analysis*; D013678:Technology, Pharmaceutical; D013997:Time Factors
D004304:Dosage Forms; D010968:Plasticizers; D011109:Polymethacrylic Acids; D013608:Tablets, Enteric-Coated; D002482:Cellulose; C011708:cellulose acetate phthalate; D008747:Methylcellulose; C053309:hydroxypropyl methylcellulose phthalate
Einfluss von Filmbildnern und Weichmachern auf die Stabilität des Resistenz- und Zerfallsverhaltens. 4. Mitteilung: Pharmazeutisch-technologische und analytische Untersuchungen an magensaftresistenten Darreichungsformen.