Use of Thermoplastic Starch in Continuous Pharmaceutical Process

Controlled release formulations of thermoplastic starch (TPS) matrix were prepared by extrusion granulation and injection molding of tablets. The compositions contained glycerol, water and on occasion urea plasticizers, glycerol-monostearate; Ca-stearate lubricants and Na-benzoate drug representing component, in addition to the starch. The lubricants and especially the urea reduce the complex viscosity of the TPS considerably facilitating the injection molding process-ability. DSC thermal analysis demonstrated, the urea is in a molecular dispersed form in the extruded granules and Raman microscopic mapping showed an under micron sized dispersion of Na-benzoate in injection molded tablets. Both the extrusion and the injection molding processing resulted retard release character of the active component.