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Published on: December 9, 2010
Enabling thermal processing of ritonavir-polyvinyl alcohol amorphous solid dispersions by KinetiSol® Dispersing
Justin S LaFountaine1, Scott V Jermain1, Leena Kumari Prasad1
1College of Pharmacy, The University of Texas at Austin, 2409 University Avenue, A1920, Austin, TX 78712, USA.
Polyvinyl alcohol can be processed into amorphous solid dispersions (ASDs) using KinetiSol® Dispersing technology, overcoming previous limitations. This breakthrough enables further research into polyvinyl alcohol
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Polyvinyl alcohol (PVA) is underutilized in amorphous solid dispersions (ASDs) due to processing challenges like thermal instability and poor solubility.
- Traditional methods like extrusion and spray drying are often unsuitable for PVA and heat-sensitive active pharmaceutical ingredients (APIs).
Purpose of the Study:
- To assess the feasibility of using PVA as a matrix polymer in ASDs with KinetiSol® Dispersing (KSD) technology.
- To investigate the impact of KSD processing parameters on the properties of ritonavir-PVA ASDs.
Main Methods:
- KinetiSol® Dispersing (KSD) technology was employed to process ritonavir-PVA ASDs.
- Powder X-ray diffraction (PXRD) and modulated differential scanning calorimetry (mDSC) were used to confirm amorphous conversion.
- Liquid chromatography-mass spectrometry (LC-MS) and carbon-13 nuclear magnetic resonance ((13)C NMR) spectroscopy analyzed drug and polymer stability.
Main Results:
- An optimal range of KSD rotor speed and ejection temperature was identified for successful processing.
- The optimized conditions yielded amorphous ritonavir-PVA with minimal degradation of the drug and polymer.
- The resulting ASD demonstrated effective drug release in a non-sink, pH-shift dissolution test.
Conclusions:
- KinetiSol® Dispersing technology enables the successful processing of amorphous solid dispersions with polyvinyl alcohol.
- This advancement opens possibilities for utilizing PVA's unique properties in formulations for poorly water-soluble compounds.
- Further studies can now explore PVA-based ASDs for enhanced drug delivery systems.
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