(317f) Influence of Mixing On the Dissolution Performance of a Pharmaceutical Dosage Form

Dissolution testing is a characterization technique employed in the pharmaceutical industry to design formulations and assess product quality. It is a required performance test by many regulatory authorities for solid oral dosage forms, and is unique in that it is intended to measure the effect of the formulation and physical properties of the active pharmaceutical ingredient (API) on the in vitro rate of drug dissolution. In a typical pharmaceutical setting, the API is synthesizes and manufactured by one team and then handed over to subsequent team which formulates the API into a dosage form. Since the dissolution characteristics of the dosage form depend not only on how it is formulated, but also on the API's powder properties, a close collaboration between the two teams is necessary. In this contribution, we present the results of the collaborative efforts between the API process development team and the formulation development team to assess and produce a product with consistent dissolution characteristics which meet established performance specifications. We also demonstrate in this work the significance of mixing on achieving the established process goals.