[Integration and innovation of wet granulation and continuous manufacturing technology: a review of on-line detection, modeling, and process scale-up]

Area of Science:

• Pharmaceutical Manufacturing
• Chemical Engineering
• Process Technology

Background:

• Continuous manufacturing presents a paradigm shift from traditional batch production, offering enhanced efficiency and control in pharmaceutical drug production.
• Despite its benefits, the pharmaceutical industry faces challenges in adopting continuous manufacturing for wet granulation due to technical complexity, high costs, and established batch processes.
• Path dependence and a lack of standardized processes impede the transition to continuous wet granulation technologies.

Purpose of the Study:

• To systematically review the current applications of wet granulation within continuous manufacturing frameworks.
• To identify and discuss critical enabling technologies for continuous wet granulation, including online detection, process modeling, and scale-up.
• To provide a valuable reference for advancing process innovation and practical implementation in continuous wet granulation.

Main Methods:

• Systematic literature review of continuous manufacturing in pharmaceutical wet granulation.
• Analysis of key technological developments: online detection, process modeling, and scale-up strategies.
• Synthesis of findings to identify challenges and opportunities for technological transformation.

Main Results:

• Continuous manufacturing offers significant advantages in efficiency and control over traditional batch methods for pharmaceutical production.
• Key technologies like online monitoring, predictive modeling, and robust scale-up methods are crucial for successful continuous wet granulation.
• Overcoming technical complexity and high investment costs are primary barriers to widespread adoption.

Conclusions:

• The integration of wet granulation into continuous manufacturing is essential for future pharmaceutical production efficiency and intelligence.
• Further development and standardization of online detection, process modeling, and scale-up are critical for advancing continuous wet granulation.
• This review provides a foundation for innovation and the successful application of continuous manufacturing principles in wet granulation processes.