Dissolution behavior was studied for four commercial batches of enteric-coated aspirin tablets from two companies. The USP XIX dissolution procedure was modified by including pretreatment in simulated gastric juice. The effects of five pretreatment times were studied. Pretreated tablets yielded higher dissolution profiles and fewer undissolved fractions than nonpretreated tablets. Among pretreatments, 15 min was adequate and 60 min produced the highest dissolution profiles. None of the pretreatments differed significantly from each other. An F test and conducted on the data indicated that Product X was significantly better than Product Y at the p=0.05 level. Batch C was ranked as the best batch irrespective of pretreatment time, followed by Batch D. Batches A and B were equal, although Batch A appeared to be better than B for the 60-min pretreatment, as indicated by the lower t80% value.
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