A Virtual Stage-Gate Approach to Developing Injection Moulds for Polymer-Based Drug-Delivery Systems

This paper presents a stage-gate procedure for designing a polymer injection mould for the production of tablet-shaped drug-delivery systems and virtual analysis of the effects of temperature, shear rate and pressure during the filling phase. The approach, its theoretical background, methods and stages are presented and discussed. The mould was designed using the commercial computer-aided design software ProEngineer. The filling phase was analyzed by means of the commercial finite-volume analysis software package Sigmasoft, Version 5.0.1. The results show that our stage-gate approach can be used to investigate moulds in terms of processing conditions in the virtual domain, which enables more accurate mould design for pharmaceutical drug-delivery systems