AptarGroup (ATR, Financial) has initiated a clinical study to validate its innovative SmartTrack platform, developed by its subsidiary, Nanopharm. The platform seeks to transform the generic drug approval process by minimizing the necessity for extensive clinical studies. This approach could potentially expedite approval times by demonstrating an ability to accurately forecast clinical outcomes.
The study will utilize radio-labelling techniques on three commercially available pressurized metered-dose inhaler products. The aim is to assess regional lung deposition, which will then be compared with predictions derived from computational fluid dynamic simulations. These simulations are conducted in collaboration with industry partners Fluidda, Medimprove, and i2c Pharmaceutical Services.
Through this study, AptarGroup aims to validate SmartTrack's capabilities, potentially revolutionizing how regulatory compliance for generic inhaler products is achieved.
