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Impact Of Critical Material Attributes (Cmas)-Particle Shape On Miniature Pharmaceutical Unit Operations., Mohammad A Azad, Gerard Capellades, Allison B Wang, David M Klee, Gregory Hammersmith, Kersten Rapp, David Brancazio, Allan S Myerson
Impact Of Critical Material Attributes (Cmas)-Particle Shape On Miniature Pharmaceutical Unit Operations., Mohammad A Azad, Gerard Capellades, Allison B Wang, David M Klee, Gregory Hammersmith, Kersten Rapp, David Brancazio, Allan S Myerson
Henry M. Rowan College of Engineering Faculty Scholarship
The U.S. Food and Drug Administration (FDA) emphasizes drug product development by Quality by Design (QbD). Critical material attributes (CMAs) are a QbD element that has an impact on pharmaceutical operations and product quality. Pharmaceutical drugs often crystallize as needle-shaped (a CMA) particles and affect the process due to poor flowability, low bulk density, and high compressibility, and eventually the product performance. In this study, the product obtained from crystallization was needle-shaped Ciprofloxacin HCl (CIPRO), formed lumps during drying, and compacted during processing through feeders. To delump small amounts of materials and break the needles, multiple available devices (mortar-pestle, Krups …