AptarGroup, Inc. a global leader in drug and consumer product dosing, dispensing and protection technologies, announces the commencement of a clinical study to validate its proprietary SmartTrack™ platform.
The platform was developed by Aptar’s drug services company, Nanopharm. If validated, SmartTrack™ aims to reduce the need for clinical studies in generic drug product approvals by proving it can accurately predict clinical outcomes – removing a major barrier for pharma companies and regulators and paving the way for wider patient access to medications. This validation would establish SmartTrack™ as a credible in-vitro-in-silico alternative to comparative clinical endpoint (CCEP) studies, and a reliable approach to derisking in vitro-pharmacokinetic (PK) only approaches, specifically for generic inhaled drug products.
The study, which is expected to begin in Q2 2025, has been carefully designed based on detailed feedback from regulatory agencies to meet the requirements for obtaining a biowaiver of the CCEP for pharmaceutical companies working with Nanopharm as well as enabling the models to provide supportive data to the in vitro studies.
The study will involve radio-labelling three different commercially available pressurized metered-dose inhaler (pMDI) drug products and imaging regional lung deposition.
These results will be compared with regional deposition predictions from computational fluid dynamic (CFD) simulations conducted in collaboration with Fluidda, Medimprove and i2c Pharmaceutical Services.
Additionally, pharmacokinetic (PK) data from subjects will be collected to validate predictions from Nanopharm’s Simhalation™ platform, which uses physiologically based pharmacokinetic (PBPK) modeling.
The resulting study data will be submitted to the U.S. FDA as one of the first Model Master Files (MMF), which would allow multiple companies to benefit from this data when partnering with Aptar, similar to the well-established Drug Master File (DMF) route.
Gael Touya, President, Aptar Pharma, stated, “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.”
In addition to supporting generic Abbreviated New Drug Application (ANDA)1 approvals, the study could also help accelerate and derisk other programs, such as the reformulation of pMDIs with new lower global warming potential (GWP) propellants, novel (drug product) combinations, developing drug products from other dosage forms, and New Chemical Entity (NCE) development into pMDIs.
The study is expected to conclude by the end of 2025. Interested parties are encouraged to contact Nanopharm to explore how this package can support their product development and approval strategies.
For more information, visit www.nanopharm.co.uk
