Comparison of single pot and multiphase granulation. Part 2: Effect of the drying process on granules manufactured in a single pot granulator and dried either in situ or in a fluid bed dryer - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Pharmaceutical Development and Technology Année : 2009

Comparison of single pot and multiphase granulation. Part 2: Effect of the drying process on granules manufactured in a single pot granulator and dried either in situ or in a fluid bed dryer

Résumé

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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Dates et versions

hal-00413030 , version 1 (03-09-2009)

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Karine Giry, Marylène Viana, M. Genty, François Louvet, P. Wüthrich, et al.. Comparison of single pot and multiphase granulation. Part 2: Effect of the drying process on granules manufactured in a single pot granulator and dried either in situ or in a fluid bed dryer. Pharmaceutical Development and Technology, 2009, 14 (2), pp.149-158. ⟨10.1080/10837450802588942⟩. ⟨hal-00413030⟩
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