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Comparative Study Among Drying Techniques in the Development of Nimesulide Tablet

机译:尼夏德平板电脑发展中的干燥技术对比研究

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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.
机译:目的:本作本作的目的是评估颗粒在干燥灶和流化床中的干燥过程的影响,以及在形成尼菊酯药物多态性的压缩阶段。方法:以相同的方式生产两种试验,Tb02和Tb06,从称重到造粒,但在干燥过程中,使用流化床干燥Tb02测试,而Tb06测试被烘箱干燥。 X射线衍射试验表明,在所有样品中,尼美的活性仍然是结晶的。结果:虽然两批测试药物在30分钟内显示出85%的尼菊酯,但TB06试验重量和硬度测试的变化系数低于TB02试验,观察到TB02测试显示更大的相似因子(F2)与参考药物相比。结论:因此,可以得出结论,作为干燥装置的流化床显示出更高的效率,并且测试药物TB02可以被认为是参考药物的药物替代品。

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