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Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms
1Academy of Pharmaceutical Sciences, c/o Bionow, Greenheys Business Centre, Manchester Science Park, Pencroft Way, Manchester M15 6JJ, UK.
Pharmaceutics
|August 28, 2021
Summary
Continuous manufacturing (CM) offers a modern approach to pharmaceutical production, aligning with the FDA's
Area of Science:
- Pharmaceutical Manufacturing
- Chemical Engineering
- Process Chemistry
Background:
- Continuous manufacturing (CM) is a production strategy where materials are continuously processed and removed.
- The U.S. Food and Drug Administration (FDA) identified CM as a 'Desired State' for pharmaceutical manufacturing in 2004.
- Despite early recognition, widespread attention and the first CM-approved product emerged around 2014-2015.
Purpose of the Study:
- To introduce the concept of continuous manufacturing (CM) in pharmaceutical production.
- To outline the advantages and disadvantages associated with implementing CM processes.
- To focus on the application of CM for small molecule solid oral dosage forms.
Main Methods:
- Literature review of continuous manufacturing principles and applications.
- Analysis of benefits and challenges in adopting CM.
- Specific focus on small molecule solid oral dosage forms within the CM context.
Main Results:
- CM aligns with the FDA's vision for advanced pharmaceutical manufacturing.
- The adoption of CM has gained momentum since 2014, with the first product approval in 2015.
- Key benefits and challenges of CM implementation are identified.
Conclusions:
- Continuous manufacturing presents a significant advancement in pharmaceutical production.
- The review serves as an introductory guide to CM for interested individuals.
- CM, particularly for small molecule solid oral dosage forms, offers potential improvements in manufacturing efficiency and quality.
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