, , , ,

Tammy ShenTammy Shen is a Ph.D. student in the Eshelman School of Pharmacy, Division of Molecular Pharmaceutics, at the University of North Carolina, Chapel Hill.

The increasing sophistication of orally inhaled and nasal drug product (OINDP) formulations and technologies has augmented the need for standardized characterization metrics, more relevant analytical techniques, and improved processing and analysis of the generated data to better predict the clinical and physiological effects of the aerosolized therapeutics. Solid state therapeutic compound and formulation properties such as crystal polymorphisms, surface roughness, electrostatic charging tendencies, and surface energy can alter drug pharmacokinetic and pharmacological properties, and as a result, an understanding of the solid state properties of inhaled drugs is critical.

These physical properties may also significantly affect the aerosol performance and therapeutic index of the drug product. Therefore, proper in vitro analytical testing is essential to progressing an OINDP formulation forward. Compounding the complexity of OINDP development is not only the interplay between the formulation and the delivery platform but also patient variation and a variety of guidance documents on the characterization of these systems. Thus, bioequivalence and statistical approaches towards quality control of OINDPs from both an industry and regulatory perspective must be aligned to better streamline the development and approval process.

To facilitate discussion and provide valuable feedback to industry and academia on the regulatory landscape and pipeline of OINDPs in both the U.S. and international markets, a comprehensive review of current and future formulation and in vitro testing technology as well as perspectives on quality control programs for OINDPs will be presented in the workshop Inhaled Drug Products: Current Practices and the Future of In Vitro Testing Technologies and Regulation, planned for September 9–10 in Rockville, Maryland. The workshop is jointly developed by the AAPS Inhalation and Nasal Technology focus group, the International Pharmaceutical Aerosol Consortium on Regulation and Science, the United States Pharmacopeial Convention, and the Food and Drug Administration.