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Development of a gastrointestinal performance simulation system for the analysis of Eltrombopag formulations
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DOI：10.1016/j.ejps.2026.107518.png)
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Abstract
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This study presents the development and application of a Gastrointestinal Performance Simulation System (GTPS) as a predictive in vitro tool for assessing the bioequivalence potential of Eltrombopag olamine formulations. Due to the poor aqueous solubility and complex ionization behavior of Eltrombopag, conventional dissolution methods often fail to predict in vivo performance accurately. The GTPS integrates multiple compartments with biorelevant media, peristaltic pumping, orbital agitation, and continuous sampling to mimic physiological gastrointestinal transit. Candidate generic formulations containing 75 mg of Eltrombopag olamine were evaluated alongside the innovator product (Revolade (R)) to identify formulations with optimal in vivo performance potential. The GTPS demonstrated improved predictive correlation with bioequivalence results compared to conventional dissolution testing. Test batches that appeared similar during dissolution analysis showed distinct release profiles when assessed with the GTPS. The GTPS provides a robust, biorelevant alternative to conventional dissolution tests, supporting the selection and optimization of formulations for bioequivalence studies of BCS Class II compounds such as Eltrombopag.
Keywords:
Gastrointestinal simulation system
Biorelevant dissolution
Eltrombopag olamine
Bioequivalence
BCS class II
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