title: Challenges and Strategies in Thermal Processing of Amorphous Solid Dispersions: A Review.
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: Division of Pharmaceutics, College of Pharmacy, The University of Texas at Austin, 2409 University Avenue, Campus Mail Code A1902, Austin, Texas, 78712, USA. justin.lafountaine@utexas.edu.
authors: Justin S
authors: JS
authors: LaFountaine
authors: Division of Pharmaceutics, College of Pharmacy, The University of Texas at Austin, 2409 University Avenue, Campus Mail Code A1902, Austin, Texas, 78712, USA.
authors: James W
authors: JW
authors: McGinity
authors: Division of Pharmaceutics, College of Pharmacy, The University of Texas at Austin, 2409 University Avenue, Campus Mail Code A1902, Austin, Texas, 78712, USA.
authors: Robert O
authors: RO
authors: Williams
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004337:Drug Carriers / Q000737:chemistry*; D004339:Drug Compounding / Q000379:methods*; D006358:Hot Temperature; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D010968:Plasticizers / Q000737:chemistry; D011108:Polymers / Q000737:chemistry; D013501:Surface-Active Agents / Q000737:chemistry
chemical_list: D004337:Drug Carriers; D004364:Pharmaceutical Preparations; D010968:Plasticizers; D011108:Polymers; D013501:Surface-Active Agents
keywords: KinetiSol® Dispersing; amorphous solid dispersions; hot-melt extrusion; plasticizers; polymers; supercritical carbon dioxide