Challenges and Strategies in Thermal Processing of Amorphous Solid Dispersions: A Review
Journal Title: AAPS PharmSciTech - Year 2016, Vol 17, Issue 1
Abstract
Thermal processing of amorphous solid dispersions continues to gain interest in the pharmaceutical industry, as evident by several recently approved commercial products. Still, a number of pharmaceutical polymer carriers exhibit thermal or viscoelastic limitations in thermal processing, especially at smaller scales. Additionally, active pharmaceutical ingredients with high melting points and/or that are thermally labile present their own specific challenges. This review will outline a number of formulation and process-driven strategies to enable thermal processing of challenging compositions. These include the use of traditional plasticizers and surfactants, temporary plasticizers utilizing sub- or supercritical carbon dioxide, designer polymers tailored for hot-melt extrusion processing, and KinetiSol® Dispersing technology. Recent case studies of each strategy will be described along with potential benefits and limitations.
Authors and Affiliations
Justin S. LaFountaine, James W. McGinity, Robert O. Williams, III
Keywords
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