AptarGroup and MGH’s Alice Stanton Launch Research Collaboration to Advance Nose-to-Brain Drug Delivery
AptarGroup, Inc. (NYSE: ATR), a global leader in drug delivery, dosing and protection technologies and consumer product dispensing, has announced a new research collaboration with Alice Stanton, PhD, of Massachusetts General Hospital (MGH), aimed at advancing the scientific understanding of nose-to-brain (N2B) drug delivery.
The collaboration will focus on developing an integrated translational research platform capable of investigating how medicines move from the nasal cavity to the brain. By combining in vitro, in vivo and computational technologies, Aptar and its research collaborators intend to characterize the mechanisms, pathways and kinetics that govern N2B transport across a broad range of molecular classes and physicochemical properties.
The initiative is designed to address some of the most important unanswered questions surrounding direct delivery of therapeutics from the nose to the brain. In particular, the partners will investigate which types of drug molecules may be most suitable for the N2B pathway, which molecular and physicochemical characteristics influence transport, and how experimental findings can be translated into development strategies for human therapies.
The research is expected to support the development of a New Approach Methodology (NAM) for evaluating potential N2B drug candidates during the pharmaceutical development process.
Advancing a Direct Route to the Brain
The blood-brain barrier remains one of the major challenges in developing medicines for neurological and central nervous system (CNS) disorders. While the barrier plays an essential role in protecting the brain, it can also restrict the ability of many therapeutic molecules to reach their intended sites of action.
Intranasal administration has attracted increasing attention as a potential alternative route because certain pathways within the nasal cavity may provide direct access toward the brain while avoiding some limitations associated with conventional systemic delivery.
Alice Stanton, PhD, Assistant Professor and Investigator in the Center for Genomic Medicine at Massachusetts General Brigham and Assistant Professor of Neurology at Harvard Medical School, said the collaboration will seek to better understand this pathway and translate that knowledge into a practical research tool.
“Through this study, we will profile the intranasal pathway to the brain and develop a tool to mimic this route, towards robust and non-invasive delivery of medicines that may otherwise be stopped by the blood-brain barrier or impeded by absorption in other tissues,” Stanton said.
“The ability to provide effective drug delivery to the brain via the nose could catalyze an inflection point for disease treatments,” she added.
The research could ultimately help pharmaceutical developers determine earlier in the development process whether a molecule is likely to benefit from N2B administration.
Growing Interest in Nasal Drug Delivery
Nasal drug delivery has become an established approach for both local and systemic therapies over the past decade. The route has supported the development of treatments across multiple therapeutic areas, while advances in formulation science and delivery-device engineering have continued to expand its potential applications.
More recently, direct nose-to-brain delivery has become an area of increasing interest as pharmaceutical companies and researchers search for alternative approaches to treating CNS diseases.
Potential applications include neurological conditions such as Alzheimer’s disease, Parkinson’s disease and multiple sclerosis, as well as disorders such as depression and other diseases affecting the brain and nervous system.
However, the scientific and development challenges associated with N2B delivery remain substantial. The nasal cavity is a complex biological environment, and the ability of a molecule to reach the brain can depend on factors including molecular characteristics, formulation, deposition location, tissue interactions and transport mechanisms.
A more systematic understanding of these factors could help researchers distinguish promising N2B candidates from molecules that are less likely to achieve meaningful brain exposure through the nasal route.
Developing a New Approach Methodology
A central objective of the Aptar collaboration is the development of a N2B New Approach Methodology.
NAMs are increasingly being explored as tools for pharmaceutical research and development, including approaches that can help reduce reliance on traditional experimental models and improve the efficiency of early-stage testing. The N2B research program is intended to align with the FDA’s support for the development and use of such approaches.
The planned methodology is expected to provide a platform for screening compounds that may be suitable for nose-to-brain delivery.
Rather than waiting until later stages of development to determine whether a candidate is compatible with the N2B pathway, pharmaceutical developers could potentially use the resulting research platform earlier to evaluate candidate molecules.
The approach is also intended to incorporate Aptar’s nasal drug delivery systems into the development framework. This could allow researchers to consider drug properties, formulation characteristics and device-related factors together rather than evaluating them as isolated components.
The resulting information could help inform candidate selection, formulation development and device-design decisions while supporting the advancement of therapies aimed at neurological diseases.
Addressing Key Questions for Pharmaceutical Developers
Despite growing interest in nose-to-brain delivery, significant scientific questions remain.
Early pioneering research, including studies conducted at Wake Forest University School of Medicine, has demonstrated that direct transport from the nasal cavity to the brain can occur. However, translating those observations into predictable pharmaceutical development strategies remains challenging.
Pharmaceutical innovators continue to investigate which molecules are best suited to the N2B pathway, what physicochemical characteristics influence transport, and how preclinical findings can be used to predict outcomes in humans.
These questions are particularly important because successful CNS drug development often requires extensive investment before researchers can determine whether a therapeutic candidate can achieve adequate exposure in the brain.
A reliable screening methodology could potentially help companies identify viable candidates earlier, reduce uncertainty and make development programs more data-driven.
Reenal Gandhi, Global Business Development Director at Aptar Pharma, said the need for such a capability is increasingly apparent among pharmaceutical innovators.
“Interest in nose-to-brain delivery has accelerated significantly in recent years, yet one of the most common questions we hear from pharmaceutical innovators is whether a specific molecule is truly suitable for this pathway,” Gandhi said.
“Our goal is to transform nose-to-brain delivery from a promising concept into a more predictable and data-driven development pathway, helping pharmaceutical innovators evaluate opportunities earlier and accelerate future CNS pipelines,” she added.
Aptar’s Experience in Nasal Delivery Technologies
Aptar brings decades of experience in nasal drug delivery research and technology development to the collaboration.
The company has invested in proprietary nasal delivery systems for approximately 30 years and has built a substantial body of field data related to nasal drug delivery. Its research has included technologies designed to facilitate deposition in the upper nasal cavity, an area of particular interest for nose-to-brain applications.
Among the technologies in Aptar’s portfolio are its Cerespray™ and Neurospray™ platforms.
These systems are designed to support targeted deposition within the nasal cavity and form part of Aptar’s broader efforts to advance delivery technologies for CNS medicines.
The company’s expertise in device development is expected to complement the biological and translational research capabilities of the Stanton laboratory.
By bringing together delivery-device engineering with research into neural pathways, molecular transport and biological systems, the collaboration aims to create a more integrated approach to understanding N2B delivery.
Combining Experimental and Computational Technologies
The planned research platform will integrate multiple approaches rather than relying on a single experimental model.
In vitro technologies will provide opportunities to investigate drug transport and interactions under controlled conditions. In vivo research will allow the collaborators to study biological processes in living systems, while computational technologies can support analysis of complex datasets and help identify relationships between molecular characteristics and delivery outcomes.
The partners intend to evaluate molecules representing a broad range of molecular classes and physicochemical properties.
Such a broad evaluation could help establish a more comprehensive picture of the factors that influence movement through the nasal pathway and toward the brain.
The goal is not simply to demonstrate whether a particular molecule can reach the brain, but to develop quantitative information about the mechanisms, pathways and kinetics involved.
This type of data could ultimately provide pharmaceutical developers with a stronger scientific basis for making decisions about N2B candidates.
Supporting Future CNS Drug Development
The potential value of the collaboration extends beyond the immediate research program. Aptar expects the proprietary tools developed through the work to support a broad range of future N2B development programs.
If successful, the resulting methodology could become part of an earlier-stage development framework for CNS therapeutics, allowing researchers to assess delivery opportunities before committing substantial resources to later development activities.
For pharmaceutical companies, earlier insight into delivery feasibility could be particularly valuable for complex neurological medicines, where achieving adequate exposure in the brain can represent a major development hurdle.
The collaboration may also help inform the relationship between the drug molecule and delivery device. Because Aptar’s nasal systems are intended to be incorporated into the research platform, developers may be able to evaluate formulation and device considerations alongside biological transport characteristics.
Stanton Lab Brings Multidisciplinary Research Expertise
The collaboration also draws on the multidisciplinary capabilities of the Stanton Lab, which operates around the concept of “Technology Towards Treatments.”
The laboratory focuses on developing technologies that can contribute to better treatments for neurological disease. Its research combines multiple scientific disciplines, including neurogenetics, omics and cell biology.
These areas are integrated with technologies spanning nanotechnology, machine learning, microfluidics, microphysiological systems, biomaterials engineering and tissue-engineered organoid approaches.
The combination of these capabilities with Aptar’s drug delivery expertise creates an opportunity to examine N2B transport from multiple perspectives.
Rather than considering nasal delivery solely as a device or formulation challenge, the collaboration seeks to understand the complete pathway, from the characteristics of the therapeutic molecule through biological transport and eventual delivery toward the brain.
Building a More Predictable N2B Development Pathway
The research collaboration reflects the growing interest in developing more precise and predictable approaches to CNS drug delivery.
Although the nose-to-brain pathway has generated significant scientific interest, its application across different therapeutic molecules remains an area of active investigation. A deeper understanding of transport mechanisms could help researchers determine which compounds are most likely to benefit from intranasal administration and how delivery systems should be designed to support those compounds.
By developing a translational platform that combines experimental and computational methods, Aptar and the Stanton Lab aim to provide a structured framework for answering these questions.
The initiative could also support the broader adoption of NAMs in pharmaceutical development by providing a specialized methodology for evaluating N2B candidates.
Ultimately, the collaboration seeks to move nose-to-brain drug delivery from a promising research concept toward a more evidence-based development pathway.
As CNS drug development continues to face challenges associated with getting medicines to the brain, new delivery strategies could play an increasingly important role. Aptar’s established nasal delivery technologies, combined with the Stanton Lab’s expertise in neuroscience, advanced biological models and emerging technologies, are intended to strengthen the scientific foundation required to advance these approaches.
Through the collaboration, the partners aim to help pharmaceutical innovators make better-informed decisions earlier in development, improve candidate and delivery-system selection, and potentially accelerate the development of new therapies for neurological and other CNS disorders.
About Aptar
Aptar is a global leader in drug delivery, dosing and protection technologies, and consumer product dispensing. Aptar partners with the world’s top healthcare and consumer brands to deliver medicines and create exceptional user experiences. Serving diverse markets, from pharmaceutical to beauty to food and beverage, Aptar combines market expertise with proprietary design, engineering and science to develop innovative solutions that help improve lives worldwide. Headquartered in Crystal Lake, Illinois, Aptar employs 14,000 dedicated people across 20 countries.