Melt Extrusion pp 435-445 | Cite as

Consistency of Pharmaceutical Products: An FDA Perspective on Hot-Melt Extrusion Process

  • Abhay Gupta
  • Mansoor A. Khan
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 9)


Hot-melt extrusion represents an efficient technology to formulate drugs with poor aqueous solubility into safe and effective drug delivery systems. The interest in this technology continues to grow as it is suitable for both high dose and potent low dose compounds. It is amenable to real-time monitoring and control of the consistency of the product with respect to content uniformity and crystalline conversion. Quality-by-design (QbD) has become an essential part of modern pharmaceutical quality systems since it incorporates an enhanced product and process understanding. It encourages real-time monitoring and control of critical material attributes and process parameters. The QbD paradigm can be easily incorporated into hot-melt processes. It has the potential to replace traditional batch processes due to its continuous nature and ease of scale-up from laboratory scale to commercial scale.


Drug Product Solid Dispersion Biopharmaceutics Classification System Process Analytical Technology Fault Tree Analysis 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The findings and conclusions in this article have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy.


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Copyright information

© American Association of Pharmaceutical Scientists 2013

Authors and Affiliations

  1. 1.Division of Product Quality Research, Office of Pharmaceutical ScienceUS Food and Drug AdministrationSilver SpringUSA

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