Gastrointestinal performance simulation system for the analysis of eltrombopag formulations

Title : Gastrointestinal performance simulation system for the analysis of eltrombopag formulations

Abstract:

Eltrombopag olamine is the active substance of the innovator product Revolade, which is indicated for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) and acquired severe aplastic anemia (SAA).

The molecule of eltrombopag acquires 6 protonatable sites as described by Meloun et al, leading to the existence of 6 ionic forms in solution, depending on the pH and ionic strength of the environment that the molecule meets. Due to the complexity of performance in solution, the predictability of in vivo behaviour of eltrombopag through the conventional in vitro methods involves several challenges, and the selection of a successful candidate as a bioequivalent developed product is not easily achieved. The present paper describes the use of a gastrointestinal performance simulation system (GTPS) to overcome such challenges.

Biography:

Stella Kafkala has studied Chemistry at the National and Kapodistrian University of Athens, Greece, with an MSc in Food Chemistry in 2002. She has worked in the pharmaceutical industry since 2003, both in Analytical Development and Regulatory Departments. She has been an external lecturer for the Pharmacy Department of Aristotle University of Thessaloniki since 2018, in the Industrial Pharmacy Post graduate Course. In parallel she is a candidate PhD student at the same school, in cooperation with the pharmaceutical industry she is currently occupied in, as an Analytical Development Director.