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.
