Comprehensive review in continuous direct compression process

다국어 초록 (Multilingual Abstract)

Background Continuous direct compression (CDC) has attracted significant attention because it offers several advantages, including high equipment utilization; low operating costs; simplification of overall production/quality assessment through online measurement, modeling, and automation; low variability through process control; low inventory levels; and reduced operator influence. Despite considerable efforts to advance pharmaceutical manufacturing through this innovation, numerous technical challenges persist for the transition from conventional direct compression (DC) to CDC.
Area covered This review comprehensively discussed the CDC processes, which are the most straightforward of the various continuous tablet manufacturing methods. This facilitates the production of tablet formulations that would otherwise be difficult using conventional batch-based DC process. To successfully develop a CDC manufacturing line beyond the current critical challenges, the key factors to consider include process analysis technology (PAT), residence time distribution (RTD), integration of the CDC manufacturing line, real-time process management, and control strategies.
Expert opinion Numerous studies have sought to implement innovative approaches in CDC development considering key factors mentioned above, demonstrating ongoing efforts in this area. Nevertheless, there are still several regulatory and technical challenges, such as enhancing the flexibility of CDC processes, developing control strategies, product collection and disposal, raw material traceability, sampling strategies, approval, recall procedures, lack of regulations, and a low level of understanding among relevant workers. To overcome these challenges, a more proactive mindset shift is essential to complete the transition from batch to CDC production. With this well-educated mindset, this transformation of innovative pharmaceutical manufacturing technologies, CDC, can be facilitated through collaboration among academia, industry, and regulatory agencies. These proactive efforts by the pharmaceutical industry will ultimately expedite the advancement of CDC and facilitate widespread adoption of CDC technologies in pharmaceutical industry.