Abstract：
Exploring the significant role of natural polymers in developing drug delivery systems has been a promising area of research interest. The current investigation uses a D-optimal quadratic mixture design to design and evaluate neem and tamarind gum-based vildagliptin extended-release matrix tablets. Studying the combination effect of gums is one of the major objectives. Initial screening studies were performed to select the factors and their levels. The variables selected at different levels in mg/tablet are neem gum, tamarind gum, polyvinylpyrrolidone, and lactose monohydrate. Based on the screening experiments with both gums, the polymer content of 165 mg was chosen as the highest level in the DOE. Nineteen runs were generated to screen the desired parameters as responses. The total weight of the formulation was kept constant at 275 mg. Time (hours) required for 50 %, 90 % and 100 % of drug release and tablet hardness were selected as the responses for each run. The wet granulation method was adopted, and the critical variables were optimised using the design of experiments following Design Expert software. Statistical analysis was conducted, and the optimised formulations were prepared and evaluated to compare with the predicted responses. Stability studies were performed for the optimised batches. Results indicated that the prepared batches met the compendial limits and confirmed the application of neem and tamarind gum in the development of extended-release tablets of vildagliptin for 24 h. An optimised formulation comprising of 16.52 mg of neem gum and 148.48 mg of tamarind gum with a hardness of 7.5-8.5 kp produced 50 %, 90 % and 100 % drug release in 12, 22 and 25 h.
摘要：
探索天然聚合物在开发药物递送系统中的重要作用一直是有希望的研究领域。当前的研究使用D-最优二次混合物设计来设计和评估基于印度和罗望子树胶的维格列汀缓释基质片剂。研究牙龈的组合效应是主要目标之一。进行初步筛选研究以选择因素及其水平。以毫克/片为单位选择的不同水平的变量是印度树胶，罗望子胶,聚乙烯吡咯烷酮,和乳糖一水合物。根据两种牙龈的筛选实验，选择165mg的聚合物含量作为DOE中的最高水平。产生19次运行以筛选所需参数作为响应。制剂的总重量保持恒定在275mg。50%所需时间(小时),选择90%和100%的药物释放和片剂硬度作为每次运行的响应。采用湿法制粒法，并使用DesignExpert软件后的实验设计对关键变量进行了优化。进行了统计分析，并制备优化的配方并进行评估以与预测的反应进行比较。对优化的批次进行稳定性研究。结果表明，所制备的批次符合药典限制，并证实了在开发维格列汀缓释片24小时中使用印尼姆和罗望子胶。包含16.52mg印尼姆胶和148.48mg硬度为7.5-8.5kp的罗望子胶的优化配方产生了50％，在12、22和25h内释放90％和100％的药物。
