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Hot-Melt Extrusion: A Versatile Pharmaceutical Technology, Hemlata Patil

Electronic Theses and Dissertations

Hot-melt extrusion (HME) is a promising technology for the production of new chemical entities in the developmental pipeline and for improving products already on the market. The first objective of this research work was to describe a continuous process for the production of solid lipid nanoparticles (SLN) as drug-carrier systems via hot-melt extrusion (HME) using Quality by Design (QbD) principles. Fenofibrate SLN were prepared by combining two processes: HME technology for melt-emulsification and high-pressure homogenization (HPH) for size reduction. Varying the process parameters enabled the production of SLN below 200 nm. At the end of a 5-h in-vitro dissolution study, …