Development of formulation and setting dissolution test specifications for IR tablets based on PBPK modeling & simulation – amiodarone as a case example

Amiodarone is a BCS class II drug, that has great variability in absorption from the gastrointestinal tract, with bioavailability between 22 and 95%. It is extensively distributed to body tissues, showing accumulation in fat and some tissues as the liver and lung. IVIVC is expected for BCS class II drugs, however, establishing a point-to-point (level A) correlation for amiodarone is a challenge. Its complex pharmacokinetics with large variable bioavailability may be the main reason for failure in establishing level A IVIVC. In this case, PBPK modeling & simulation (M&S) and IVIVR can help internally in pharmaceutical companies, to set relevant dissolution test specifications and to guide the formulation development process.

In this webinar, Dr. Marcelo Dutra Duque, Adjunct Professor in the Department of Pharmaceutical Sciences at the Federal University of São Paulo – UNIFESP, Brazil, will present a case example on the use of PBPK M&S to support the development of an IR tablet formulation containing amiodarone hydrochloride and setting more relevant dissolution test specifications.

Speaker: Dr. Marcelo Dutra Duque