Prajapati Shailesh T, Patel Amit N, Patel Chhagan N
Department of Pharmaceutics, Shri Sarvajanik Pharmacy College, Mehsana, Gujarat 384001, India.
ISRN Pharm. 2011;2011:208394. doi: 10.5402/2011/208394. Epub 2011 Jun 27.
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 3(2) full factorial design. The ratio of HPMC K4M and PVP K30 (X(1)) and the concentration of melt binder (X(2)) were selected as independent variables, and drug release at 1 hr (Q(1)), 4 hr (Q(4)), 8 hr (Q(8)), 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 Q(1), Q(4), n, and K Binder concentration 25% w/w was found optimum. Optimized formulation (F(7)) showed good similarity with theoretical profile of drug. The X(2) variable had a significant effect on dependent variables, and the X(1) variable had no significant effect on dependent variables.
本研究采用3(2)全因子设计，描述了聚乙二醇6000（PEG 6000）作为熔融黏合剂的浓度以及羟丙甲纤维素K4M（HPMC K4M）与聚乙烯吡咯烷酮（PVP）的比例对酒石酸唑吡坦控释片制剂的影响。将HPMC K4M与PVP K30的比例（X(1)）和熔融黏合剂的浓度（X(2)）选为自变量，将1小时（Q(1)）、4小时（Q(4)）、8小时（Q(8)）的药物释放量、扩散系数（n）和释放速率常数（K）选为因变量。通过熔融制粒技术制备片剂，并对各种评价参数进行评估。结果发现，熔融黏合剂的浓度对Q(1)、Q(4)、n和K有显著影响，黏合剂浓度为25%（w/w）时最为适宜。优化后的制剂（F(7)）与药物的理论曲线具有良好的相似性。X(2)变量对因变量有显著影响，而X(1)变量对因变量无显著影响。
