Studies in Formulation Development of Low Dose Content Drug Using Fluid Bed Granulation Technique
Journal Title: Journal of Pharmaceutical Sciences and Research - Year 2010, Vol 2, Issue 4
Abstract
To achieve acceptable content uniformity, a granulation process is generally utilized. Fluid bed granulation, wet granulation, dry granulation was used for granulation purpose for formulation of sustained release tablets. Carbopol 934P solution (1 % w/v) was used as a granulating solution in the fluid bed granulator. For comparative evaluation, tablets were also prepared by direct compression and wet granulation, and subjected to dissolution. Tablets prepared by fluid bed granulation technique prolonged the release of Diclofenac Sodium better than tablets obtained by direct compression and wet granulation. Further, it complied with the requirements of ICH guidelines for stability testing. Higher temperature and humidity (40±2°C/ 75% RH, 40°C, 50°C, and 60°C) adversely affected the rate and extent of the dissolution. Diclofenac Sodium SR tablets stored in amber-colored bottles demonstrated good photo stability for 6 months at 600ft candle. The shelf-life of the formulation was predicted as 32 months.
Authors and Affiliations
Tejas Patel , L. D. Patel , Timir Patel , Sunil Makwana , Tushar Patel
Keywords
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