Revealing Polymorphic Phase Transformations in Polymer-Based Hot Melt Extrusion Processes.

ABSTRACT: The inadvertent occurrence of polymorphic phase transformations in active pharmaceutical ingredients (APIs) during hot melt extrusion (HME) processes has been claimed to limit the application of this technique. Hence, the control of polymorphism would need to be addressed if there is any prospect of HME to be successfully implemented as an alternative solid dosage formulation strategy in integrated, continuous end-to-end pharmaceutical manufacturing settings. This work demonstrates that flufenamic acid (FFA), one of the most polymorphic APIs known, thus far, can be processed using temperature-simulated HME with polyethylene glycol (PEG) as polymeric carrier. At temperatures above the transition point of FFA forms III and I (42 °C), the induction time of the polymorphic phase transformation

SUBMITTER: Espinell JRH 

PROVIDER: S-EPMC6936767 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature