Nanopharm is a pivotal player in the development of generic Orally Inhaled and Nasal Drug Products (OINDPs), including enabling the market to access medication through the launch of generic products through the provision of  In-Vitro Bioequivalence (IVBE) studies, a scientific approach to demonstrate the bioequivalence of a generic product to its Reference Listed Drug (RLD).

A critical aspect of this process involves adhering to the stringent requirements set by major regulatory agencies, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). These agencies have established clear in-vitro criteria for nasal and inhaled drug products for the core in-vitro assessment, with continued evolution of the clinical and alternative non-clinical pathways. These criteria dictate the tests that are necessary to characterize various critical performance attributes and statistically compare the reference drug to the test articles. 

To achieve this, Nanopharm has developed specialized platforms capable of assessing the key physicochemical properties of inhaled or nasal products and the associated performance with the selected drug delivery system, to ensure the API, formulation and device are also equivalent and providing drug product bioequivalence. These in-vitro tests are pivotal in allowing scientists and regulators to understand how all of the components of a complex combination product interact and transform en route from device to patient.

These largely follow the product specific guidances and include tests for delivered dose uniformity (DDU), spray pattern (SP), plume geometry (PG), particle or droplet size distribution (DSD), and aerodynamic particle size distribution (APSD), using state of the art instrumentation to allow for precision and accuracy when developing and validating the methods, as well as designing the IVBE study to meet regulatory expectations. Nanopharm can also perform the other CMC and drug product characterization studies required for your ANDA submission and ongoing GMP batch release and stability studies.

However, Nanopharm’s approach goes beyond mere compliance to the historical standards. We have pioneered advanced in-vitro and in-silico tools that are changing the entire regulatory pathway for generic products through our long-standing collaboration with regulators and innovative development of OINDP technologies. These  are integral to understanding the microstructural (Q3) properties of formulations, and how the patient affects the pharmacodynamic and pharmacokinetic performance of the product; effectively and objectively to simulate a clinical study without touching a patient. 

The implications of Nanopharm’s approach are far-reaching. By focusing on the microstructural equivalence of formulations and leveraging IVBE, Nanopharm is not only streamlining the process of demonstrating bioequivalence but also contributing to the development of optimized and stable drug product formulations. This approach paves the way for faster market access to inhaled or nasal medications, which is beneficial not only to patients but also to healthcare providers and the broader pharmaceutical industry.