Comparative effect of different types of food on the bioavailability of cefaclor extended release tablet.

Author(s): Khan BA, Ahmed T, Karim S, Monif T, Saha N, Sharma PL

Affiliation(s): Department of Pharmaceutical Medicine, Faculty of Pharmacy, Majeedia Hospital, Jamia Hamdard, Hamdard University, Hamdard Nagar, New Delhi, India.

Publication date & source: 2004-04, Eur J Drug Metab Pharmacokinet., 29(2):125-32.

Publication type: Clinical Trial; Randomized Controlled Trial

This randomized, six-treatment, six-period, six sequence, single dose, crossover pharmacokinetic study assessed the effect of different types of food on the bioavailability of 500-mg cefaclor extended release tablet in 23 healthy male volunteers. A single dose of cefaclor extended release 500-mg tablet was administered at six occasions: after overnight fasting, after two vegetarian (high-fat and low-fat), two non-vegetarian (high-fat and low-fat) and rice diets. Serial blood samples were collected up to 12 h after dose. Serum cefaclor concentrations were determined by a validated HPLC method. An almost equivalent increase in both Cmax and AUC was observed with both high-fat non-vegetarian and low-fat vegetarian breakfasts. However, when MIC90 values, a pharmacodynamic end-point were compared, the low-fat vegetarian diet fared better than the high-fat non-vegetarian diet. The results obtained favor low-fat vegetarian diet (breakfast) to be taken with cefaclor extended release tablet to achieve maximum benefit in terms of clinical efficacy.