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• W2269570064 abstract "Polyvinyl alcohol has received little attention as a matrix polymer in amorphous solid dispersions (ASDs) due to its thermal and rheological limitations in extrusion processing and limited organic solubility in spray drying applications. Additionally, in extrusion processing, the high temperatures required to process often exclude thermally labile APIs. The purpose of this study was to evaluate the feasibility of processing polyvinyl alcohol amorphous solid dispersions utilizing the model compound ritonavir with KinetiSol® Dispersing (KSD) technology. The effects of KSD rotor speed and ejection temperature on the physicochemical properties of the processed material were evaluated. Powder X-ray diffraction and modulated differential scanning calorimetry were used to confirm amorphous conversion. Liquid chromatography–mass spectroscopy was used to characterize and identify degradation pathways of ritonavir during KSD processing and 13C nuclear magnetic resonance spectroscopy was used to investigate polymer stability. An optimal range of processing conditions was found that resulted in amorphous product and minimal to no drug and polymer degradation. Drug release of the ASD produced from the optimal processing conditions was evaluated using a non-sink, pH-shift dissolution test. The ability to process amorphous solid dispersions with polyvinyl alcohol as a matrix polymer will enable further investigations of the polymer’s performance in amorphous systems for poorly water-soluble compounds." @default.
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• W2269570064 date "2016-04-01" @default.
• W2269570064 modified "2023-10-15" @default.
• W2269570064 title "Enabling thermal processing of ritonavir–polyvinyl alcohol amorphous solid dispersions by KinetiSol® Dispersing" @default.
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• W2269570064 doi "https://doi.org/10.1016/j.ejpb.2016.01.018" @default.
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