Abstract
The influence of food, namely the four typical regional meals of India-Punjabi (P), South Indian (SI), Gujarati (G) and West Bengali (WB)-on the extent and rate of the bioavailability of aspirin (600 mg) and acetaminophen (500 mg) was studied after a single oral dose administered to 60 healthy volunteers divided into two groups, each group consisting of 30 volunteers. Each group was given aspirin and acetaminophen, respectively. Each group was further divided into five subgroups of six volunteers each. Subgroup A in both groups received the drug in a fasting state, while the rest of the subgroups B, C, D and E received the respective drug with the assigned regional meal. Urine samples were collected every hour for a period of 6 h and the urinary recovery of salicylic acid (SA) and 4 p-amino phenol (4 p-AP) was estimated. The WB meal followed by the SI meal resulted in a significant increase in the urinary recovery level of both drug metabolites as compared to the fasting state levels. The administration of aspirin resulted in the occurrence of peak urinary SA levels in the fourth hour in the fasting state and in the second and third hours with the test meals. The urinary 4 p-AP levels were highest in the first hour in the fasting state and with the SI and G meals, but with the P and WB meals, peaking was delayed until the fifth hour. In general, the WB meal showed a delay in the occurrence of the peak urinary levels of the drug metabolites, probably due to its high protein, high fat and low fibre contents, followed by the SI meal. These results strongly suggest that the composition and relative nutrient contents of a meal influence the bioavailability of these drugs.