Journal
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY
Volume 14, Issue 2, Pages 149-158Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1080/10837450802588942
Keywords
High shear wet granulation; double jacket vacuum drying; fluid bed drying; full factorial design; formulation; granule properties; compressibility; dissolution kinetic
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The aim of this study was to highlight the effect of the drying process on granules manufactured in a pilot scale single pot granulator and dried either in situ or in a fluid bed dryer, for formulations differing in drug substance and its concentration (1%; 25%). Although most of raw data were within specifications, single pot drying tended to improve granule comprimability and seemed less sensitive to formulation. Moreover, it was demonstrated that the formulation impacted on granule median diameter, packing ability, comprimability, residual lower punch pressure and tablet dissolution kinetics. Interactions between process and formulation were highlighted concerning tablet tensile strength and uniformity of mass.
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