Evaluation of dissolution behavior for the products containing Tegafur andUracil

Citation
M. Azuma et al., Evaluation of dissolution behavior for the products containing Tegafur andUracil, YAKUGAKU ZA, 119(10), 1999, pp. 773-779
Categorie Soggetti
Pharmacology & Toxicology
Journal title
YAKUGAKU ZASSHI-JOURNAL OF THE PHARMACEUTICAL SOCIETY OF JAPAN
ISSN journal
00316903 → ACNP
Volume
119
Issue
10
Year of publication
1999
Pages
773 - 779
Database
ISI
SICI code
0031-6903(199910)119:10<773:EODBFT>2.0.ZU;2-X
Abstract
Generic drugs are widely used with the object of cost saving in many Japane se therapeutic scenes now. The products containing the same active ingredie nt(s), even if they are innovative drugs or generic ones, must be designed to possess the equivalent quality. In this report, we observed the dissolut ion behavior patterns of three generic drugs that contain Tegafur and Uraci l, drugs A, B and C, and compared them with that of an innovative product, UFT. Drugs B and C were similar to UFT in the dissolution rate of Tegafur, but drug A was not. On the dissolution rate of Uracil, all the generic prod ucts, drugs A, B and C, did not amount to the level equivalent to that of U FT. Therefore, these generic products did not indicate the same dissolution behavior pattern as UFT. It was suggested that the pharmaceutical technolo gy used in the manufacture was not equivalent even if the products of the s ame dosage form contain the same kind and content of the active ingredient( s).