Correlation of Dissolution, Disintegration, and Bioavailability of Aminosalicylic acid Tablets

Rank-order correlations are demonstrated among dissolution, disintegration, and several measures of bioavailability for tablets of aminosalicylic acid and its salts. The correlation between disintegration time and the percent of the dose excreted in the urine is examined quantitatively using both linear and quadratic models. The results support the use of either disintegration or dissolution tests to control the availability of this drug and suggest control limits for these tests. The suggested limits on the disintegration tests are shorter than those currently specified in USP XVIII monographs on these items.