ISSN : 2663-2187

Polymer Selection and Characterization for Hot Melt Extruded Formulations: A Review of Recent Advances and Challenges

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Vishnu A S, Harshitha R, Eric Christopher Lobo, Harish K H, Rajesh K S, Midhun Mathew K.
ยป doi: 10.33472/AFJBS.6.10.2024.3748-3760

Abstract

The purpose of this literature review is to investigate the selection and characterization of polymers for Hot Melt Extrusion (HME) formulations, a novel pharmaceutical manufacturing technology that improves the solubility and bioavailability of pharmaceuticals with low water solubility. Thermal processing of heat-sensitive drugs and polymers with undesirable properties is difficult. Creating superior HME formulations requires understanding these elements. In the pharmaceutical industry, studying starch thermal degradation and stability under different processing conditions is useful. The study examines how amylose and amylopectin ratios, starch modification, and processing environment affect starch-based materials, emphasizing the importance of chemical and thermal stability, drug-polymer interactions, drug loading, miscibility, and compatibility in HME formulations. Improved HME technology has improved medical formulations, especially abuse-deterrent formulations. The thermal properties of HME polymers have improved with the addition of high thermal conductivity nanofillers. HME product quality and productivity depend on process understanding and optimization. To translate laboratory-scale formulations to commercial production, scale-up methods for HME products have been extensively researched. The requirements, challenges, and opportunities of using HME technology in pharmaceutical manufacturing have been extensively studied

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