Critical review on the role of excipient properties in pharmaceutical powder-to-tablet continuous manufacturing
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View abstract on PubMed
Summary
This summary is machine-generated.Continuous manufacturing offers advantages over batch processing, but raw material properties significantly impact its efficiency and quality. This review examines excipient roles in continuous processes and identifies challenges for optimization.
Area Of Science
- Pharmaceutical Manufacturing
- Chemical Engineering
- Materials Science
Background
- The pharmaceutical industry is transitioning from batch to continuous manufacturing for improved efficiency and quality.
- Raw material properties critically influence continuous manufacturing outcomes, but existing knowledge from batch processing is not directly applicable.
- Understanding excipient behavior in continuous processes is essential for successful implementation.
Purpose Of The Study
- To review the impact of excipient properties on unit operations within continuous pharmaceutical manufacturing.
- To identify challenges and propose solutions for optimizing continuous manufacturing processes.
- To provide a framework for advancing process optimization and formulation development in continuous manufacturing.
Main Methods
- Literature review focusing on excipient properties and their role in continuous manufacturing unit operations.
- Analysis of unit operations including feeding, blending, granulation, final blending, and compression.
- Expert opinion synthesis on challenges and solutions for continuous manufacturing.
Main Results
- Excipient properties significantly affect key unit operations in continuous manufacturing, including feeding, blending, granulation, and compression.
- Direct transfer of batch processing knowledge regarding raw material properties to continuous manufacturing is limited.
- Several challenges hinder the full utilization of continuous manufacturing, requiring targeted solutions.
Conclusions
- Addressing the challenges in continuous manufacturing is crucial for realizing its full potential.
- Optimizing excipient selection and understanding their behavior across unit operations are key to successful continuous manufacturing.
- This review provides a foundation for pharmaceutical companies to enhance process optimization and formulation development in continuous manufacturing.
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