Assessing and Generating Useful Drug Dissolution Profiles – A Practical and Bio-relevant Approach

This article provides a discussion based on data presented in the literature that a direct comparison of dissolution results (profile) with blood levels (C-t profiles) can lead to misleading interpretation. For a more appropriate comparison, dissolution results should first be converted to C-t (plasma drug conc.-time) profiles. Examples are provided for converting dissolution profiles, using convolution techniques, to C-t profiles, which improve dissolution results evaluation. The article also presents an argument that for proper reflection of bio-relevancy of dissolution results, the tests require higher agitation (or product/medium interaction) relative to what is provided by the paddle apparatus at 50 and 75 rpm. please click here for the complete article

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