Impact of Cream Composition on Critical Quality Attributes of Miconazole Nitrate Vaginal Creams

Introduction: In vitro characterization-based bioequivalence (BE) approaches have been well-established for topical dermatological products. However, these have yet to be developed for locally-acting (LA) vaginal cream products. A comprehensive understanding of how critical material attributes influence critical quality attributes (CQAs) of LA vaginal creams is essential for the development of such BE strategies. The present study aims to elucidate the impact of cream composition on the CQAs and in vitro performance of LA vaginal creams, using miconazole nitrate (MN) vaginal creams as the model product.