The effect of food on the absorption characteristics of nitrofurantoin from a commercial capsule dosage form containing macrocrystalline drug and a commercial tablet dosage form containing microcrystalline drug was assessed in human subiects by a urinary excretion method. In fa~ting subiects, less nitrofurantoin was absorbed and at a slower rate, and attained lower body levels when the capsule rather than the tablet dosage form was orally administered. When each was administered with food, the absorption of nitrofurantoin was appreciably delayed. Food in the gastrointestinal tract produced an increase in the peak body levels of nitrofurantoin from the macrocrystalline form. No effect of food was observed on the maximum levels after the microcrystalline form. There were increases of 80% and 30% in the bioavailability of nitrofurantoin in nonfasting as compared to fasting subiects, of macro crystalline nitrofurantoin capsules and microcrystalline nitrofurantoin tablets, respectively. There was an increase in the duration of therapeutic urinary concentrations of nitrofurantoin when either form was taken with food. The comman practice of using fasting subiects in bioavailability studies of drug products normally administered with food is questionable.NitrofurantOin, 1-[ (5-nitrofurfurylidene) amino] hydantoin, is a broad-spectrum antibacterial agent used extensively in the treatment of urinary tract infections. It is a weak acid (pKa 7.2) and is poorly soluble at the normal pH of the gastrointestinal (GI) tract. Its dissolution rate, absorption rate, and bioavailabilit y 4, 9, 12, 14 are dependent on its particle size.Adverse reactions associated with nitrofurantoin therapy are nausea and vomiting,
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