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15 May 2019

Alternative regulatory path for generic Respiratory Products


The document provides a detailed description of SmartTrack™, a solution offered by Nanopharm for the updated FDA approval process for generic respiratory products. On 15th May 2019, the FDA provided an alternative pathway to the currently recommended comparative clinical endpoint bioequivalence (BE) study for an abbreviated new drug application (ANDA) submission of a solution metered dose inhaler (Qvar Redihaler). 

SmartTrack™ combines the recording of breath profiles with realistic aerodynamic particle size distribution performance testing, using representative mouth-throat models, in-vitro dissolution, and morphology directed particle sizing and chemical imaging of a representative lung dose and regional deposition modelling, together with physiologically-based pharmacokinetic (PBPK) models for predicting local and systemic exposure. 

The paper also discusses the high cost of clinical trials, with companies needing to spend in excess of $100m to bring any AB rated inhaled drug to the US market. The estimated cost of a single, 900+ person clinical endpoint BE study would be $45m. An alternative to clinical endpoint BE would dramatically decrease program costs and increase the net present value (NPV) of respiratory generic products. 

SmartTrack™ has been specifically developed by Nanopharm to expedite the requirements of an alternative BE approach for orally inhaled and nasal drug products. It uses proprietary aerosol collection apparatus (UniDose) to investigate the in-vitro dissolution, formulation microstructure, and realistic aerodynamic particle size distribution (APSD) performance of test and reference products with representative mouth-throat models. 

The document also provides insight into advanced in-silico modeling tools that investigate the relationship between in vitro based measurements and predictive regional deposition, and the local rate and extent of absorption of the therapeutic dose from OINDPs. These advanced modeling tools also provide insight into patient-device interaction and information about both local and systemic bioavailability, which can better characterize both critical device and formulation attributes.

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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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