Elham Amini, Simon M Berger, Uta Schilling, Yuanyuan Jiao, Mong-Jen Chen, Sagar Bachhav, Sandra M Baumstein, Yufei Tang, Mohammed Al-Humiari, Carmen E Leon Astudillo, Stefanie Drescher, Teresa Iley, Jagdeep Shur, Robert Price, Cynthia Carrasco, Denise S Conti, Renishkumar Delvadia, Oluwamurewa Oguntimein, Kimberly Witzmann, Mohammad Absar, Markham C Luke, Susan Boc, Sneha Dhapare, Bhawana Saluja, Elizabeth Bielski, Bryan Newman, Jürgen B Bulitta, Günther Hochhaus
To assess bioequivalence of locally acting suspension-based nasal sprays, the U.S. FDA currently recommends a weight-of-evidence approach. In addition to in vitro and human pharmacokinetic (PK) studies, this includes a comparative clinical endpoint study to ensure equivalent bioavailability of the active pharmaceutical ingredient (API) at the site of action. The present study aimed to assess, within an in vitro/in vivo correlation paradigm, whether PK studies and dissolution kinetics are sensitive to differences in drug particle size for a locally acting suspension-based nasal spray product...
September 29, 2023: Molecular Pharmaceutics