This comprehensive study delves into the complexities of achieving bioequivalence for Orally Inhaled and Nasal Drug Products (OINDPs), with a particular focus on the nasal spray suspension formulations. The research primarily revolves around the commercial product Nasonex™ (mometasone furoate monohydrate) and four test nasal suspension formulations containing the same active pharmaceutical ingredient (API). The study meticulously examines the morphology and particle size distribution of both the “as received” API batches and the formulated nasal suspension formulations. The research provides valuable insights into the challenges and potential solutions in achieving bioequivalence for such complex drug products. It underscores the importance of understanding the intricate relationship between the particle size of the API and the release behavior of API when tested under sink conditions. This study is a valuable resource for professionals in the pharmaceutical industry, regulatory authorities, and researchers working on the development and approval of generic orally inhaled and nasal drug products.
Interview with Jane Provis Evans, Head cGMP services at Nanopharm
In the ever-evolving world of pharmaceuticals, the importance of stringent quality control cannot be overstated. This interview with Jane Provis-Evans, Head of cGMP Analysis at Nanopharm, sheds light on the critical role of cGMP testing in the development and optimization of drug-device combinations, particularly for orally inhaled and nasal drug products (OINDPs). With the launch of Nanopharm’s new GMP services, the company is well-positioned to help clients bring innovative treatments to patients.