Abstract
Felodipine is an antihypertensive substance acting as a calcium antagonist. The substance is provided as an extended release (ER) formulation obtained by a slowly eroding tablet. For the quality control of this tablet an automated dissolution testing system has been developed. The purpose of the present study was to validate the performance of the system. A chemometric approach using fractional factorial and D-optimal designs was applied. The obtained data were evaluated by projection methods, providing a validation of seven independent experimental variables and their interactions, seen as their influence on the in vitro dissolution rate of felodipine from the ER tablet in a predefined dissolution system. The benefits of such chemometric methodology were obvious, exemplified by the disclosure of synergism and quadratic relationships 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 the drug-release rate in the present system.
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