Jan Syed Umer, Khan Gul Majid, Hussain Izhar
Department of Pharmacy, University of Balochistan, Quetta, Pakistan.
Pak J Pharm Sci. 2012 Oct;25(4):751-6.
The aim and objective of the present study was to formulate and evaluate controlled release polymeric tablets of ibuprofen with determinations of formulation factors using various grades and types of polymer ethocel i.e. ethocel standard 10P; 10FP, 100P and100FP for their release rates and release patterns in suitable media and also the mechanism involved in the release of drug from the matrices. The effect of several co-excipients was also studied on the drug release rates and patterns of Ibuprofen from the polymeric matrices. Ibuprofen-ethocel CR tablets were prepared at three different D: P ratios i.e. 10:1, 10:2 and 10:3. The effects of co-excipients were studied only in formulations having D: P ratio of 10:3. In vitro drug release studies of ibuprofen-ethocel controlled release matrix tablets were carried out in phosphate buffer pH 6.8 using pharma test dissolution apparatus adopting rotating basket method according to USP. Different kinetic models were applied to the release data of test formulations in order to investigate the release mechanism of drug from the controlled release matrix tablets. The release patterns of ibuprofen-ethocel CR matrices were compared with reference conventional ibuprofen tablets and ibuprofen SR tablets. F2 similarity factor was applied to the test formulations and reference standard to compare their similarities. The drug formulations studied exhibited satisfactory release results.
本研究的目的是制备并评价布洛芬控释聚合物片,使用不同等级和类型的聚合物乙基纤维素(即乙基纤维素标准品10P、10FP、100P和100FP)测定制剂因素,以考察其在合适介质中的释放速率和释放模式,以及药物从基质中释放的机制。还研究了几种辅料对布洛芬从聚合物基质中的药物释放速率和模式的影响。以三种不同的药物与聚合物比例(即10:1、10:2和10:3)制备布洛芬-乙基纤维素控释片。仅在药物与聚合物比例为10:3的制剂中研究辅料的影响。采用旋转篮法,在pH 6.8的磷酸盐缓冲液中,使用药物试验溶出仪,按照美国药典进行布洛芬-乙基纤维素控释基质片的体外药物释放研究。将不同的动力学模型应用于试验制剂的释放数据,以研究药物从控释基质片中的释放机制。将布洛芬-乙基纤维素控释基质的释放模式与参比普通布洛芬片和布洛芬缓释片进行比较。将F2相似因子应用于试验制剂和参比标准品,以比较它们的相似性。所研究的药物制剂显示出令人满意的释放结果。