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ACTA Pharmaceutica Sciencia
2004 , Vol 46 , Num 1
A SYSTEMATIC APPROACH TO SCALEMUP THE HIGH-SHEAR GRANULATION PROCESS FOR MEBENDAZOLE TABLETS TO ACHIEVE A SCALE-INDEPENDENT DRUG RELEASE
Department of Pharmacy, Annamalai University, Annamalai Nagar, Tamil Nadu , India
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The optimized high-shear vet granulation process variables quantified on 1.5 kg batch were scaled up to 90 kg production scale for the manufacture of. mebendazole tablets to achieve the scale invariant drug release. The matching granulation properties and dissolution profiles were obtained by the use of a constant impeller-tip velocity in all the high-shear scale-up mixers used. The resultant end point of granulation remained reproducible regardless of scale of manufacture.
Keywords :
ECHINOCOCCOSIS, HIGH-SHEAR GRANULATION, SCALE-UP, TIP VELOCITY, DYNAMIC SIMILARITY, DRUG RELEASE