title: Hot-melt extrusion--basic principles and pharmaceutical applications.
abstract: Originally adapted from the plastics industry, the use of hot-melt extrusion has gained favor in drug delivery applications both in academia and the pharmaceutical industry. Several commercial products made by hot-melt extrusion have been approved by the FDA, demonstrating its commercial feasibility for pharmaceutical processing. A significant number of research articles have reported on advances made regarding the pharmaceutical applications of the hot-melt extrusion processing; however, only limited articles have been focused on general principles regarding formulation and process development. This review provides an in-depth analysis and discussion of the formulation and processing aspects of hot-melt extrusion. The impact of physicochemical properties of drug substances and excipients on formulation development using a hot-melt extrusion process is discussed from a material science point of view. Hot-melt extrusion process development, scale-up, and the interplay of formulation and process attributes are also discussed. Finally, recent applications of hot-melt extrusion to a variety of dosage forms and drug substances have also been addressed.
authors: Division of Pharmaceutics, College of Pharmacy, The University of Texas at Austin , Austin, TX , USA.
authors: Bo
authors: B
authors: Lang
authors: James W
authors: JW
authors: McGinity
authors: Robert O
authors: RO
authors: Williams
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004304:Dosage Forms; D005079:Excipients / Q000737:chemistry; D006358:Hot Temperature; D006801:Humans; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D004304:Dosage Forms; D005079:Excipients; D004364:Pharmaceutical Preparations
keywords: Amorphous solid dispersion; co-crystal; controlled release; film; implant; melt extrusion; polymer selection; process development; scale-up