By: IPP Bureau
Last updated : April 19, 2025 10:52 am
SmartTrack aims to reduce the need for clinical studies in generic drug product approvals
AptarGroup, 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.
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.