VALIDATION OF AN EXTENDED-RELEASE TABLET DISSOLUTION TESTING SYSTEM USING DESIGN AND MULTIVARIATE-ANALYSIS

Felodipine is an antihypertensive substance acting as a calcium antago nist. The substance is provided as an extended release (ER) formulatio n obtained by a slowly eroding tablet. For the quality control of this tablet an automated dissolution testing system has been developed. Th e purpose of the present study was to validate the performance of the system. A chemometric approach using fractional factorial and D-optima l designs was applied. The obtained data were evaluated by projection methods, providing a validation of seven independent experimental vari ables and their interactions, seen as their influence on the in vitro dissolution rate of felodipine from the ER tablet in a predefined diss olution system. The benefits of such chemometric methodology were obvi ous, exemplified by the disclosure of synergism and quadratic relation ships between descriptor variables and the responses (i.e., amount of felodipine released after a given time of dissolution). Changes in the temperature and the stirring speed had the most profound effects on t he drug-release rate in the present system.