Abstract
The in vitro dissolution rate of 3 commercial phenytoin (PHT) products with different particle sizes (PHT A-1, A-2 from manufacturer A, and PHT B from manufacturer B) was examined by USP rotating basket method. The difference of the dissolution rate was due to the difference in particle sizes. Particularly in the 1st fluid, 2nd fluid and borate buffer with 0.1% Polysorbate 80, the dissolution rate was significantly enhanced in the order of PHT A-l<PHT A-2< PHT B. The quantity of Polysorbate 80 was related to the dissolution rate of PHT B, but not of PHT A-1 and PHT A-2. These findings should have resulted from the difference in the pharmaceutical factors.