Aptar Launches Study to Speed FDA Approval of SmartTrack™ Platform for Inhalers
AptarGroup, Inc., a global leader in drug delivery and consumer product dispensing systems, has announced a pivotal step in the advancement of its pharmaceutical services with the initiation of a clinical study to validate its proprietary SmartTrack™ platform. Developed by its specialized drug development subsidiary Nanopharm, SmartTrack™ is poised to redefine regulatory pathways for generic inhaled drug products by offering a scientifically robust, clinically supported alternative to traditional clinical endpoint studies.
With the planned commencement of the study in the second quarter of 2025, Aptar aims to deliver a transformative shift in the development and regulatory approval of generic respiratory drugs—specifically, pressurized metered-dose inhalers (pMDIs). If the SmartTrack™ platform is successfully validated, it could significantly streamline the approval process by providing a credible in-vitro-in-silico methodology to predict clinical performance. This could ultimately reduce or even eliminate the need for time-consuming and costly comparative clinical endpoint (CCEP) studies, a major hurdle in the development of generic inhaled therapies.
Bridging the Gap Between In Vitro Testing and Clinical Outcomes
The SmartTrack™ platform represents the convergence of advanced simulation technologies and pharmacokinetic modeling with traditional in vitro analysis. At its core, SmartTrack™ integrates several cutting-edge tools including:
- Computational Fluid Dynamics (CFD) for simulating airflow and particle deposition within the lungs;
- Physiologically Based Pharmacokinetic (PBPK) modeling through Nanopharm’s Simhalation™ software to predict how a drug behaves in the human body after inhalation;
- High-precision radiolabeling and imaging to verify drug deposition in specific regions of the lungs.
This combined in-vitro-in-silico approach not only promises to predict clinical outcomes with high accuracy but also presents a compelling case for regulators to accept it as a valid surrogate for in vivo clinical studies. By reducing reliance on large-scale human trials, Aptar hopes to cut down development time and costs, thus facilitating faster and more affordable access to respiratory treatments, especially generics.
The Study Design: Scientific Rigor and Regulatory Alignment
Aptar’s upcoming clinical study has been meticulously designed in alignment with regulatory guidance and with the input of agencies such as the U.S. Food and Drug Administration (FDA). The study will include the use of three existing commercially available pMDI drug products that will be radio-labelled for precise measurement of lung deposition. Through imaging techniques such as gamma scintigraphy, researchers will be able to observe the regional distribution of the drug within the respiratory tract following administration.
This actual lung deposition data will then be compared against deposition patterns predicted by CFD simulations conducted in collaboration with established partners: Fluidda, Medimprove, and i2c Pharmaceutical Services. These simulations model how drug particles travel through the complex airway geometries and ultimately deposit in various lung regions.
Simultaneously, pharmacokinetic data will be collected from human volunteers to validate predictions generated by Nanopharm’s Simhalation™ PBPK modeling platform. This dual comparison—between imaging data and simulation, as well as between real-world pharmacokinetics and model predictions—will provide robust validation of SmartTrack™ as a comprehensive predictive platform.
Submitting the Model Master File (MMF): A Shared Scientific Resource
One of the key innovations in Aptar’s regulatory strategy is its plan to submit the results of this study to the U.S. FDA as a Model Master File (MMF). This is a novel regulatory filing format inspired by the established Drug Master File (DMF) system, but tailored for model-based product evaluations.
The MMF is designed to serve as a shared scientific resource that other pharmaceutical companies can reference in their own regulatory submissions. For developers of generic inhaled therapies who partner with Aptar and Nanopharm, this means they can leverage the validated models and data from the SmartTrack™ platform without having to recreate the studies themselves—drastically reducing both time and expense.
This model-based framework represents a significant evolution in regulatory science, aligning with global regulatory bodies’ increasing interest in model-informed drug development (MIDD) and quantitative tools to support decision-making.
Implications for Generic ANDA Approvals and Beyond
While the immediate focus of SmartTrack™ is on facilitating Abbreviated New Drug Application (ANDA) approvals for generic inhaled products, the broader implications of this platform extend far beyond generics. If proven effective, SmartTrack™ could be a game-changer in several additional contexts:
- Reformulation of existing pMDIs with environmentally friendly propellants: As the pharmaceutical industry faces increasing pressure to reduce greenhouse gas emissions, many companies are exploring propellants with lower global warming potential (GWP). SmartTrack™ could help demonstrate bioequivalence and therapeutic equivalence between formulations, accelerating the transition to greener technologies.
- Development of combination drug products: Inhalers that deliver two or more active ingredients simultaneously are increasingly popular in treating conditions like asthma and COPD. SmartTrack™ can help derisk the development of these complex products by accurately simulating deposition and PK profiles of each component.
- Bridging to new chemical entities (NCEs): For novel molecules delivered via inhalation, SmartTrack™ may support early-stage development and provide confidence in formulation decisions, potentially shortening the path to Investigational New Drug (IND) and New Drug Application (NDA) filings.
- Dosage form transitions: Companies looking to transition an existing oral or injectable therapy to an inhaled route could benefit from SmartTrack™’s simulation-based approach to assess feasibility, optimize formulations, and predict systemic exposure.
Industry Endorsement and Future Outlook
Aptar Pharma President Gael Touya expressed optimism about the upcoming clinical validation study, calling it a “significant milestone in the evolution of Aptar’s offerings.” He added, “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.”
The clinical study is expected to run through the end of 2025, with data submission to the FDA and MMF publication to follow. Pharmaceutical companies interested in leveraging SmartTrack™ for their own drug development programs are encouraged to engage early with Nanopharm to explore customized integration of the platform into their regulatory strategies.
Shaping the Future of Inhalation Drug Development
With the launch of this clinical validation study, AptarGroup and Nanopharm are positioning SmartTrack™ at the forefront of a new era in inhaled drug development. By combining advanced simulation technologies with rigorous scientific validation, SmartTrack™ aims to make inhalation drug development faster, more cost-effective, and more accessible to companies worldwide. If successful, the platform could reduce Aptar dependence on human clinical trials for bioequivalence testing, set new standards for regulatory submissions, and dramatically improve patient access to vital respiratory medications.
As global healthcare systems continue to seek efficiency, innovation, and sustainability, platforms like SmartTrack™ may become central pillars in the next generation of pharmaceutical development.
