A study on the roller compaction of undulated flakes by real-time process monitoring of compaction and cone milling of flakes

Abstract

NIR spectroscopy has already been exploited for real-time monitoring of critical quality attributes of smooth roller compacted flakes. However, there has been no reported research undertaken on the undulated flakes. Furthermore, the comminution of flakes which has enormous impact on manufacturing of finished dosage forms has also not been well studied. The first section of this study was directed at assessing the use of NIR spectroscopy for the real-time process monitoring of undulated flakes production. It was shown that NIR spectroscopy could successfully monitor content uniformity and critical quality attributes (tensile strength, Young¿s modulus and relative density) of undulated flakes by appropriate selection of spectral acquisition mode, NIR probe positioning, spectral preprocessing method and beam size. In the second section of the study, the cone milling process for undulated roller compacted flakes was studied. Impeller sidearm shape, screen surface profile and impeller speed showed significant influence on granule attributes, fines generated, energy consumed and milling rate. A study on the applicability NIR real-time monitoring for the prediction of the post-milled granule attributes, percent fines, energy consumption and milling rate was also carried out. Real-time NIR predicted data suggested that granule attributes could be successfully predicted with a high level of accuracy in an efficient and non-destructive manner. Overall, findings from this project study serve as a step forward towards achieving the objectives using process analytical technologies to advance the quality-by design (QbD) approach in pharmaceutical production.