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Formulation and Evaluation of Controlled-Release Tablet of Zolpidem Tartrate by Melt Granulation Technique

机译:熔融制粒技术制备酒石酸唑吡坦控释片

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摘要

The present investigation describes the influence of the concentration of PEG 6000 as a melt binder and ratio of HPMC K4M : PVP on Zolpidem tartrate controlled-release tablet formulations using 32 full factorial design. The ratio of HPMC K4M and PVP K30 (X1) and the concentration of melt binder (X2) were selected as independent variables, and drug release at 1 hr (Q1), 4 hr (Q4), 8 hr (Q8), diffusion coefficient (n), and release rate constant (K) were selected as a dependent variable. Tablets were prepared by melt granulation technique and evaluated for various evaluation parameters. It was observed that concentration of melt binder had significant effect on Q1, Q4, n, and K Binder concentration 25% w/w was found optimum. Optimized formulation (F7) showed good similarity with theoretical profile of drug. The X2 variable had a significant effect on dependent variables, and the X1 variable had no significant effect on dependent variables.
机译:本研究描述了采用32种全因子设计的PEG 6000熔体粘合剂浓度和HPMC K4M:PVP比例对酒石酸唑吡坦控释片剂的影响。选择HPMC K4M和PVP K30的比例(X1)和熔融粘合剂的浓度(X2)作为自变量,分别在1?hr(Q1),4?hr(Q4),8?hr(Q8)的药物释放,扩散系数(n)和释放速率常数(K)作为因变量。通过熔融造粒技术制备片剂,并评价各种评价参数。可以看出,熔融粘合剂的浓度对Q1,Q4,n有显着影响,发现K粘合剂的最佳浓度为25%ww / w。优化的配方(F7)与药物的理论特征具有良好的相似性。 X2变量对因变量有显着影响,而X1变量对因变量没有显着影响。

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