Abstract:
Objective: The present work has as objective to evaluate the influence of the drying process of the granules in the drying stove and in the fluidized bed, as well as, as stages of compression in the formation of nimesulide drug polymorphism. Method: Two tests, TB02 and TB06 were produced in the same way, from weighing to granulation, but during the drying process the TB02 test was dried using the fluidized bed, while the TB06 test was oven dried. X-ray diffraction tests show that, in all samples, the nimesulide active remains crystalline. Result: Although both batches of test drugs show 85% release of nimesulide in 30 mins and the coefficient of variation values for the TB06 test weight and hardness tests are lower than the TB02 test, it was observed that the TB02 test showed the greater similarity factor (F2) when compared to the reference drug. Conclusion: Thus, it can be concluded that the fluidized bed as a drying apparatus shows a greater efficiency and that the test drug TB02 can be considered as a pharmaceutical alternative to the reference medicine.
Key words: Nimesulide, Polymorphism, Comparative dissolution, Drying techniques, Similarity factor.
