A Novel In Vitro Tool for Formulation Optimization and Streamline the Selection of Suitable Candidate Formulations for Bioavailability and Bioequivalence Studies in Humans

Jibin Li, Nourdine Nessah, Yuehua Huang, Svitlana Silchenko, and Ismael J. Hidalgo

This poster was presented at the Controlled Release Society Meeting (CRS) 2016

Drug product manufacturers and most regulatory agencies rely on well-established tests such as content uniformity, product disintegration, and drug release (dissolution), to evaluate the quality of oral solid dosage forms. These tests are useful to verify compliance with product specifications; however, as a result of their lack of physiological relevance, it is difficult to judge whether these measurements are sufficient to ensure a consistent therapeutic effect among different lots of a product. We have developed an experimental model, in-vitro dissolution absorption system 2 (IDAS2), to evaluate the interplay between drug product dissolution and drug permeation. Because IDAS2 incorporates experimental conditions that take into account the temporal overlap of these processes after oral administration, it will permit to obtain data that is more translatable to the in vivo performance of the products.