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European versus United States Pharmacopeia …

European versus United States Pharmacopeia Disintegration Testing Methods for Enteric-Coated Soft Gelatin Capsules J. Al-Gousous and P. Langguth*. Institute of Pharmacy and Biochemistry, Johannes Gutenberg University, Mainz, Germany e-mail: ABSTRACT. The aim of this work was to investigate the differences between the disintegration testing methods specified by the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.) for enteric-coated soft gelatin capsules. Disintegration of the coated capsules in the pH buffer stage of the test was much faster under the conditions specified by Ph.

Dissolution Technologies UUS 2015 7 MATERIALS AND METHODS Materials Uncoated size 4 oval placebo soft gelatin capsules were received as a …

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