Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032, West Bengal, India.
Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032, West Bengal, India.
Int J Biol Macromol. 2014 Aug;69:430-4. doi: 10.1016/j.ijbiomac.2014.05.075. Epub 2014 Jun 5.
The present study delineates the fabrication of maltodextrin based proniosomes of nateglinide and their potential as controlled delivery system for diabetic therapy. New Zealand albino male rabbits have been used as animal model for in vivo study. To evaluate the bioavailability of nateglinide proniosome, a rapid, simple and sensitive HPLC method with photodiode array detection was developed and validated to determine nateglinide in rabbit plasma. Chromatographic separation was achieved by a reverse phase C18 column using a mixture of acetonitrile:methanol:10mM phosphate buffer (pH 3.5) in the ratio of 56:14:30 (%v/v) as the mobile phase at a flow rate of 1.0ml/min and quantified based on drug/IS peak area ratios. Gliclazide was used as the internal standard. The intra- and inter-day relative standard deviations of four tested concentrations were below 2%. The nateglinide proniosome formulation exhibited significantly higher plasma concentration than those of pure drug. The study revealed that the rate and extent of absorption of nateglinide from the proniosomal formulation was comparatively enhanced that of pure drug. Maltodextrin based proniosomes of nateglinide is not only simple and cost efficient delivery but also offers a useful and promising carrier for diabetic therapy through oral administration.
本研究描述了基于麦芽糊精的那格列奈前体囊泡的制备及其作为糖尿病治疗的控释系统的潜力。新西兰白兔被用作体内研究的动物模型。为了评估那格列奈前体囊泡的生物利用度,开发并验证了一种快速、简单和灵敏的 HPLC 方法,并用光电二极管阵列检测来测定兔血浆中的那格列奈。通过反相 C18 柱,以乙腈:甲醇:10mM 磷酸盐缓冲液(pH 3.5)的比例为 56:14:30(%v/v)的混合物作为流动相,在 1.0ml/min 的流速下实现了色谱分离,并根据药物/IS 峰面积比进行定量。格列齐特被用作内标。四个测试浓度的日内和日间相对标准偏差均低于 2%。那格列奈前体囊泡制剂的血浆浓度明显高于纯药物。研究表明,那格列奈从前体囊泡制剂中的吸收速度和程度得到了比较显著的提高。基于麦芽糊精的那格列奈前体囊泡不仅是一种简单且具有成本效益的给药方式,而且通过口服给药为糖尿病治疗提供了一种有用且有前途的载体。