Inhalation Drug Delivery: Considerations for Toxicology and Pharmacology Research

Drug delivery to the lungs in both the clinical and non-clinical setting is a unique combination of formulation, delivery device and the system/model that the drug is being delivered to. Throughout different stages of drug development, the requirements for inhalation drug delivery change and the delivery system must change/evolve to meet the needs at each stage. Early proof-of-concept studies may make use of rodent species, simple formulations that minimize excipients, ‘off-the-shelf’ delivery devices and may utilize direct to the lungs as an option.

Pharmacology experiments utilize a balance of robust formulation/delivery systems with translational animal models. In contrast, IND and NDA enabling studies utilize large and small animals, well defined/developed formulations, devices designed to support the proposed clinical program and inhalation delivery to the lungs. This presentation will cover the merger of formulations, devices and models throughout the development process with a focus on the risks/benefits of different options at different development time points. 

Topics will include:

• An introduction to the combination of formulation, translational non-clinical models and drug development
• Inhalation drug delivery throughout drug development
• Translatable pharmacology models in respiratory disease
• Toxicology study designs
• How inhalation drug development can be accomplished

Speakers

Philip Kuehl, PhD, Scientist, Director of Scientific Core Laboratories, Lovelace Biomedical

Dr. Philip Kuehl holds a bachelor’s degree in biochemistry from Hamline University in St. Paul, MN and a PhD from the University of Arizona, College of Pharmacy in Pharmaceutical Sciences. He has been at Lovelace since 2007. Dr. Kuehl’s research interests are in the area of inhalation formulation and its effects on pulmonary dose, deposition, pharmacokinetics and pharmacodynamics. Aerosols he has studied have included therapeutic, disease inducing and infectious diseases. Recently he was a part of the working group for the standardization of deposition imaging studies. Dr. Kuehl is a current member of the American Association of Pharmaceutical Scientists, Association of Inhalation Toxicologists, International Society of Aerosols in Medicine, and American Association of Aerosol Researchers. He is also currently an Adjunct Professor at the University of New Mexico, College of Pharmacy. Philip also serves as an ad-hoc reviewer for several inhalation and pharmaceutical science-based journals. 

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Edward Barrett, PhD, Senior Scientist, Senior Director, Pharmacology, Lovelace Biomedical

Ted Barrett is Director, Translational Sciences-Pharmacology and Senior Scientist at Lovelace Biomedical and Environmental Research Institute (LBERI). Dr. Barrett has a long history and track record of performing cardiovascular, respiratory, and neurological assessments in large animal species. He is a 17-year member of the LBERI staff. Dr. Barrett received his PhD in toxicology from the University of Rochester prior to joining Lovelace.

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