Abstract
Sustained release nitrofurantoin granules containing stearic acid and glyceryl monostearate (matrix) were prepared using fusion, solvent evaporation or melt granulation techniques. The effect of Aerosil, Avicel, dibasic calcium phosphate dihydrate (Emcompress) and sodium chloride as channeling agents on the in vitro release of nitrofurantoin was investigated. The results obtained revealed that, with the granules prepared by the fusion method a sustained release pattern could be achieved contrary to those prepared by the other techniques. Moreover, all the selected channeling agents increased the extent of the drug release but with different rates depending upon their concentration and nature. The release of the drug was found to follow the Higuchi model with granules containing 0 and 5% channeling agents while, it followed first-order kinetics with those containing 10% of channeling agent. In vivo studies in humans revealed that the urinary excretion of nitrofurantoin from the test granules occurred over a sustained period from 2–8 hours after oral administration.
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