两种不同技术优化瑞格列奈渗透给药系统

R. Salfi, Fatima Shireen, M. Ajitha
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引用次数: 1

摘要

本研究旨在建立一种基于初级渗透泵(EOP)和推拉渗透泵(PPOP)的控释药物传递系统,以实现抗糖尿病药物瑞格列奈的缓释。EOP法和PPOP法湿法制备瑞格列奈片。EOP设计了15个配方F1-F15,用PPOP法制作了14个配方。所有的配方进行了各种物理化学参数和体外溶出度的研究。将释放数据拟合到数学动力学模型研究中,以验证释放机理。此外,通过FTIR和稳定性研究对两种方法的优化配方进行了表征。EOP法和PPOP法成功制备了瑞格列奈渗透片。所有的配方对所有的评价参数都显示出满意的结果。EOP法制备的F15释药率最高,为99.76%;PPOP法制备的FF14释药率最高,为99.73%。通过体外溶出度分析,优选处方F15和FF14具有零级Korsmeyer-Peppas动力学和Fickian扩散控制释放机制,且24 h内释药量高。FTIR药物-赋形剂相容性研究表明,药物与赋形剂之间没有明显的相互作用。经过3个月的加速稳定性研究,配方是稳定的。EOP和PPOP的设计是为了在较长时间内有效地给药瑞格列奈。
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Optimization of Repaglinide Osmotic Drug Delivery System Using Two Different Techniques
The current study aimed to formulate an elementary osmotic pump (EOP) and push-pull osmotic pump (PPOP) based drug delivery system for controlled release of an anti-diabetic agent, repaglinide is expected to provide sustained release. EOP and PPOP method prepared repaglinide tablets by wet granulation technique. EOP designed 15 formulations F1-F15 and 14 formulations were done by PPOP method. All the formulations were evaluated for various physicochemical parameters and in-vitro dissolution studies. The release data was fitted into mathematical kinetic modeling studies to check the release mechanism. Further, the optimized formulations from both methods were characterized by FTIR and stability studies. EOP and PPOP methods successfully prepared repaglinide osmotic tablets. All the formulations exhibitedb satisfactory results for all evaluated parameters. The highest drug release was exhibited from F15 prepared by EOP method with 99.76% and FF14 with 15% coating prepared by PPOP method with drug release of 99.73%. Based on the in vitro dissolution profile, formulation F15 and FF14 exhibited zero-order with Korsmeyer-Peppas kinetics with Fickian diffusion-controlled release mechanism with high drug release in 24 hours and hence were selected as optimized formulations. The drug-excipient compatibility study by FTIR indicated no significant interactions between drugs and excipients. The formulations were stable after 3 months of accelerated stability studies. EOP and PPOP were designed to effectively administrate repaglinide drugs for a prolonged period of time.
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