The development of a thin-film rollforming process for pharmaceutical continuous manufacturing

Abstract

In this thesis, a continuous rollforming process for the folding of thin-films was proposed and studied as a key step in the continuous manufacturing of pharmaceutical tablets. HPMC and PEG based polymeric thin-films were considered for this application. An experimental apparatus was designed and developed to test the folding of thin-films. The experimental apparatus was designed in a modular fashion to facilitate testing of various process parameters. Analysis was carried out for the folding operations, based on which two folding strategies were proposed - (i) without scoring and (ii) with scoring. The first strategy relies on elastic deformation of the thin-films, whereas the later depends on localized, plastic deformation caused by the scoring geometry. From the experiments on folding we identified three regimes of process operation namely: insufficient scoring, appropriate scoring, and excessive scoring. The implications of different levels of scoring were observed and understood carefully for the scoring and folding operation. Practical guidelines were developed for carrying out folding successfully and the scope of future work was discussed.