Translation of inhaled exposure throughout drug development: A case-study on how to de-risk formulation development and secure clinical exposure  

Rebecca Fransson1, Carolyn Stevensson2 & Ulrika Tehler1

1Advanced Drug Delivery, Pharmaceutical Science, R&D, AstraZeneca, 43183 Gothenburg, Sweden

2Early Product Development & Manufacturing, Pharmaceutical Science, R&D, AstraZeneca, 43183 Gothenburg , Sweden


Biopharmaceutics is a skill area residing within pharmaceutical sciences and relates the physicochemical properties of a drug in a dosage form to the pharmacology, toxicology, or clinical response observed after its administration. The major responsibility of a biopharmaceutics expert within the industrial setting is to ensure that the drug product reliably delivers the intended exposure in animal and clinical studies. Specialized inhalation biopharmaceutics focuses on drug delivery to, and sometimes, through the lungs. Inhaled drug delivery requires expert knowledge within several scientific disciplines, but the core technical skill areas for an inhaled biopharmaceutics researcher resides within the aerosol testing, dissolution and absorption area. Scientific understanding on how the formulation, the inhalation device and relevant physiology impacts the drug product performance is the mainstay of an inhaled biopharmaceutics representative assignment in the industrial setting.

This talk will focus on the successful inhaled biopharmaceutics approach that was undertaken in order to translate inhaled exposure throughout the early development process of AZD8154, to de-risk formulation development and ensure clinical exposure in future clinical studies.