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06 Dec 2018

Challenges in OINDPs Achieving Q3 Equivalence


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.

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Nanopharm Announces Exclusive Collaboration With Fluidda To Accelerate Regulatory Pathway For OINDP Using SmartTrack

Crystal Lake, Illinois, September 22, 2022 – Nanopharm, an Aptar Pharma company and leader in contract research and development services for orally inhaled and nasal drug products (OINDPs), today announced an exclusive collaboration with Fluidda, a leader in the field of Functional Respiratory Imaging. The companies will leverage their respective proprietary technology platforms to help accelerate U.S. Food & Drug Administration (FDA) approvals for orally inhaled generic products (OIDPs) via the alternative bioequivalence pathway. Nanopharm was acquired by Aptar (NYSE: ATR) in 2019, as part of the company’s strategy to expand its services offerings and partner with pharmaceutical companies earlier in the drug development process.

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