Continuous manufacturing and process analytical technology: focusing on dosage forms with improved solubility and controlled release

Abstract

BackgroundThe implementation of continuous manufacturing (CM) processes has become a significant trend in the advancement of the pharmaceutical industry. Reports have demonstrated that conventional batch processes, such as blending, granulation, and tableting, have been successfully integrated into the CM process. Studies have also indicated that using appropriate process analytical technology (PAT) tools enhances product quality within the CM process.Area coveredSolubility enhancement and drug release control have been traditionally considered high-demand and valuable technologies in the pharmaceutical industry. This article reviews recent approaches in CM and PAT research relating to these technologies.Expert opinionPharmaceutical processes such as hot-melt extrusion, coating, spray-drying, electrospinning, and milling are integrated into CM process and are employed for solubility enhancement or drug release control. A single continuous process machine is considered a suitable candidate for integration into the CM process. Examples of such machines include hot-melt extruders and continuous coaters. Many studies have applied PAT to CM, however most of them have focused on immediate-release formulations. This review strives to comprehensively elucidate various cases of CM processes utilizing real-time PAT tools. Their promising results are expected to contribute to the expanded applicability of CM processes.