@article{article_1636653, title={ASSESSMENT OF BIORELEVANT MEDIA TO ANTICIPATE FOOD EFFECT OF ORAL RITONAVIR AMORPHOUS SOLID DISPERSIONS}, journal={Journal of Faculty of Pharmacy of Ankara University}, volume={49}, pages={729–742}, year={2025}, DOI={10.33483/jfpau.1636653}, author={Oktay, Ayşe Nur and Polli, James}, keywords={Biouyumlu ortam, film, ritonavir, yiyecek etkisi}, abstract={Objective: The objective was to evaluate the polymers effects on solubility, solubilization capacity and dissolution of films in biorelevant media, thus, to understand the main mechanism underlaying RTN’s negative food effect.
Material and Method: Amorphous films were prepared with various polymers via solvent-casting method, then solubility, solubilization capacity and dissolution studies were performed in biorelevant media (FeSSIF-V2 and FaSSIF-V2) and maleic acid buffers (pH 5.8 and 6.5).
Result and Discussion: Polymer rank-order to increase RTN solubility in FeSSIF-V2 was SoluPlus>EudragitS100>PVPVA=PEG6000>HPMCAS-L. For FaSSIF-V2, only EudragitS100, SoluPlus and PVP-VA increased RTN solubility. Solubilization capacity studies showed that RTN release was higher for 20% drug loaded films than for 40% for all polymers except for HPMCAS H in FeSSIF-V2, and for HPMCAS-H and HPMCAS-L:H in FaSSIF-V2. In FeSSIF-V2, dissolution studies showed that RTN films from HPMCAS-L and PVP-VA provided higher RTN release compared to other polymers in early time points. AUC(0-120 min) in FaSSIF-V2 media was 9.0-fold, 8.3-fold, 5.9-fold, and 5.0-fold higher for SoluPlus, HPMCAS-L, PVPVA and HPMCAS-L:H, respectively, compared to crystalline RTN. Although, RTN’s negative food effect, which was not replicated here in vitro, may be due to more complex interactions between drug, polymer, and food in vivo than simulated here using FeSSIF-V2 and FaSSIF-V2.}, number={3}, publisher={Ankara Üniversitesi}