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Disintegration Tester for Oral Dispersible Film

Orodispersible films (ODF) are novel dosage forms. Since 2012, they are monographed in European Pharmacopoeia. The pharmacopoeial definition says “Orodispersible films are single- or multilayer sheets of suitable materials, to be placed in the mouth where they disperse rapidly”. To determine rapid dispersion, suitable disintegration test systems are required. Other than for tablets, there is no standardized test setup available due to the novelty of the monograph. Therefore, this study aims to present two novel approaches to determine disintegration times of ODFs. One test was designed according to the pharmacopoeial tablet disintegration tester and the other to provide a system with automated end-point detection.

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