Therapeutic equivalence of Levodopa products -in vitro studies-



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The dissolution rates of eight products containing Levodopa in three strengths and made by two different manufacturers have been determined using a continuous flow dissolution apparatus. There was no significant difference between a 100 mg. tablet of one manufacturer and a 100 mg. capsule of the other manufacturer. Significant difference was observed in the 250 mg. capsules made by the different manufacturers. At 250 mg. strength the dissolution of the capsule differed from that of the tablet of the same manufacturer. There was no significant variation in 500 mg. tablets or capsules made by different manufacturers. The unit-to-unit variation within the same product was varied from one product to the next. The change in strength was found to influence dissolution rate significantly. All products studied passed the U.S.P. XVIII content uniformity test.