From Continuous Manufacturing to Continuous Monitoring for Hot Melt Extrusion (HME) Process: Applications and Challenges of in-line NIR Monitoring
Posted on June 14, 2016
By: Rutesh H. Dave, Ph.D.1, 2 Division Director of Pharmaceutical Sciences
Kenneth R. Morris, Ph.D.1, 3 University Professor
Rohit P. Dugar1, 2 Ph.D. Candidate
1Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, NY, USA
2Natoli Institute for Industrial Pharmacy Research and Development at the Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, NY, USA
3Lachman Institute for Pharmaceutical Analysis at the Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, NY, USA
Summary Hot melt extrusion has been used and widely accepted as a continuous process for preparing high energy amorphous solid dispersions or melt granules and other mixtures for drug delivery. Content uniformity and API stability monitoring on a continuous basis is the new challenge that the pharma...
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Related Topics and Keywords
amorphous solid dispersions, API stability monitoring, ASD, Content uniformity, Continuous Manufacturing, Continuous Monitoring, continuous process, HME, Hot melt extrusion, In-line NIR monitoring, Kenneth R. M, Lachman Institute for Pharmaceutical Analysis, LIU, Long Island University, melt granules, Natoli Institute for Industrial Pharmacy, Pharmaceutical Sciences, Rohit P. Dugar, Rutesh H. Dave
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