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27 Sep 2019

Faster, Cost-Effective Alternative to Generic Bioequivalence


This article, presented by Nanopharm, an Aptar Pharma company, reviews the challenges that companies face in bringing generic respiratory and nasal therapies to market. It explores how organizations have proactively addressed these challenges and developed services to integrate the device and the formulation. The article focuses on the concept of structural Q3 equivalence for Orally Inhaled and Nasal Drug Products (OINDPs), a vital approach for the industry. It introduces SmartTrack, a process that combines the recording of inspiratory breath profiles with realistic aerodynamic particle size distribution performance testing. This approach provides the critical elements required to meet the alternative requirements and eliminate clinical endpoint bioequivalence studies, accelerating and de-risking generic product development. The article concludes by highlighting the benefits of this alternative approach, including reduced development time and cost, providing companies with a clear and compelling competitive advantage.

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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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