AptarGroup announced that its subsidiary Nanopharm is initiating a clinical study to validate the SmartTrack in-vitro-in-silico modeling platform as an alternative to clinical endpoint studies for determining bioequivalence of inhaled drug products. The study will also collect PK data for validation of Nanopharm’s Simhalation physically-based pharmacokinetic (PBPK) modeling platform for OINDP development. Study data will be submitted for an FDA model master file.
According to Aptar, the study will compare deposition data from three different radio-labeled MDIs with CFD simulations and involves collaborations with Medimprove, i2c Pharmaceutical Services, and Fluidda. Nanopharm and Fluidda announced in 2022 that they would work together on an alternative bioequivalence method using Nanopharm’s SmartTrack development platform and Fluidda’s FRI technology.
Aptar Pharma President Gael Touya commented, “This clinical study marks a significant milestone in the evolution of Aptar’s offerings. Providing clinically validated data to our pharmaceutical partners and regulatory bodies will be crucial in demonstrating the platform’s viability, which could lead to accelerated approvals and broader access to generic inhaled medicines for more patients.”
Read the Aptar press release
