Physicochemical Properties and Dissolution of 1-(2-Tetrahydrofuryl)-5-Fluorouracil Fine Granules

Drug dust rising from powder preparations while being weighed in the balance often poses question. Special care is required when the drug is powerful drug such as anticancer agent. Physicochemical test and dissolution test were conducted on 6 brands of anticancer agents in fine granule containing 1-(2-tetrahydrofuryl)-5-fluorouracil so as to compare their equivalency and to observe the possible dispersion of drug dust. Physicochemical test was made with use of powder tester and dissolution test with sartorious solubility simulator. Test fluids used were 1st fluid (pH 1.2, J. P. IX), 2nd fluid (pH 7.5, J. P. IX) and water (pH 5.6). Results: 5 brands out of 6 proved to have dispersion rate of more than 30%, suggesting that a due care must be taken in their handling. In the dissolution test, no significant difference (not less than 5%) was observed among test fluids and brands.