Solid state thermomechanical engineering of high-quality pharmaceutical salts: Via solvent free continuous processing

Abstract

Thermomechanical engineering of pharmaceutical salts in the solid state using continuous extrusion processing (ssTME) is a new novel manufacturing approach. In the present work, we introduce a paradigm for the synthesis of ketoconazole-oxalic acid and ciprofloxacin-maleic acid salts by imparting temperature, shear rate and stress in comparison to liquid assisted grinding (LAG) approach. We demonstrated that thermomechanical synthesis is advantageous by producing high quality and pure, solvent-free pharmaceutical salts by tailoring extrusion processing variables.