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27 Sep 2020

In Vitro System for Orally Inhaled Drug Release


This article explores the challenges and solutions in the development of orally inhaled drug products (OIDPs). It discusses the need for alternative bioequivalence pathways and the importance of in vitro studies that measure the local rate and extent of absorption of a representative lung dose. The article also introduces Nanopharm’s next-generation, patented, aerosol dose collection apparatus that can harmonize both in vitro dissolution and in vitro release testing of OIDPs. This innovative approach removes the guesswork and provides pharmaceutical partners with an unprecedented level of confidence in their data. The article further discusses the concept of microstructural Q3 equivalence testing for locally acting products, essentially increasing the evaluation of pharmaceutical equivalence through physicochemical and functional product characteristics.

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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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