Comparison of single pot and multiphase high shear wet granulation processes related to excipient composition

Journal of Pharmaceutical Sciences
K GiryD Chulia

Abstract

At present time, industrial production imperatives can require the transposition of a formulation from one equipment to another. In order to evaluate the impact of such a switch on the properties of granules and tablets, investigations were undertaken on formulations manufactured both in a single pot mixer-granulator-dryer (high shear granulator with in situ double jacket vacuum drying) and in a multiphase equipment (high shear granulator/fluid bed dryer). Principal component analysis highlighted the major contribution of the binder ratio on granule size distribution, flow and packing ability whereas the relative ratio of mannitol and lactose, used as fillers, mainly impacted on compressibility and tablet cohesion. In the studied domain, the lubricant ratio did not explain the considered responses. Statistical analysis (comparison of means, analysis of variance and PCA) showed that both processes led to products with similar characteristics which demonstrated the ability of the processes to produce granules with close quality. However, Fielder/Niro granule characteristic data were found to be more dispersed, thus demonstrating a higher sensitivity of the multiphase process to formulation changes. Technological properties of gra...Continue Reading

References

Jun 1, 1985·The Journal of Pharmacy and Pharmacology·R J Roberts, R C Rowe
Aug 1, 1998·Journal of Controlled Release : Official Journal of the Controlled Release Society·R V NelloreL L Augsburger
Mar 29, 2001·International Journal of Pharmaceutics·H MurakamiM Kobayashi
Apr 17, 2002·International Journal of Pharmaceutics·Julia Z H GaoM A Hussain
Apr 28, 2004·Drug Development and Industrial Pharmacy·Debra S Hausman
Jun 2, 2005·Pharmaceutical Development and Technology·Marylène VianaDominique Chulia
Oct 20, 2006·International Journal of Pharmaceutics·Agota Hegedus, Klára Pintye-Hódi

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