期刊
AAPS PHARMSCITECH
卷 17, 期 1, 页码 43-55出版社
SPRINGER
DOI: 10.1208/s12249-015-0393-y
关键词
amorphous solid dispersions; hot-melt extrusion; KinetiSol (R) Dispersing; plasticizers; polymers; supercritical carbon dioxide
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 (R) Dispersing technology. Recent case studies of each strategy will be described along with potential benefits and limitations.
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