Abstract
About this talk
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.
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