Initial assessment of hot-melt extrusion for processing API with a wide range of physical properties to form consistent solid dispersion : HPMC-Affinisol paracetamol system

摘要

The aim of this work is to: (1) Determine the viable processing window of HPMC-Affinisol polymer to use in hot melt extrusion. (2) Use this polymer for oral formulations with Paracetamol over a wide range of physical grades and determine the effect of API particle size on the nature of the resulting formulated mixtures. (3) Assess if HME can be used to produce a consistent output with wide ranges in physical input API properties.