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| Bestimmung der Zerfallszeit von Schmelztabletten mit Hilfe der Texture Analyser-Methode Reinhard Bohnackera, Frank Streilb, Stephan Schweizerb und Ingrid Müllera Hochschule Albstadt-Sigmaringena, Fachbereich Life Sciences, Studiengang Pharmatechnik, Sigmaringen, und Merckle GmbHb, Blaubeuren-Weiler Determination of the Disintegration Time of Mouth Melt Tablets with Texture Analyser Method Mouth Melt Tablets (MMT) are being mar-keted only since a few years. The European Pharmacopoeia describes mouth melt tablets for the first time in 2002. Due to easy application the popularity of MMT increases especially in the field of children’s or geriatric medicine. This is a growing market, what is correlating with an increasing number of patent applications. For research and development in the field of pharmaceutical technology it is often necessary to determine and describe the process of the disintegration of mouth melt tablets. Thus the influ-ence of different manufacturing parameters can become apparent. The effects of different ingredients on the dissolution rate can be analysed as well. More-over, determining the disintegration rate of mouth melt tablets is a very important criterion of quality control. The dissolution method described in the European Pharmacopoiea does not allow to completely characterize this process. It was the aim of joint project to examine and describe exactly and realistically very small differences in the dissolution parameters of a selection of commercially available mouth melt tablets. The obtained results should allow to improve the pharmaceutical-technological formulation and procedure development for mouth melt tablets. Several methods for the determination of the disintegration time were compared. The method used in the following publication leads to highly reproducible results. Hereby the dissolution rate, starting and ending point of the dissolution procedure, the dissolution profile, the penetration way of the punch, the difference between band height and penetration way are important parameters. Key words Mouth Melt Tablets • Schmelztabletten, galenische Entwicklung • Testure Analyser • Zerfallszeit |
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pharmind 2005, Nr. 3, Seite 327
