Hafeez Abdul, Razvi Nighat, Talib Nasira, Ghayas Sana, Anjum Fakhsheena, Bushra Rabia
Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.
Nazeer Hussain University, Karachi, Pakistan.
Pak J Pharm Sci. 2019 May;32(3 (Supplementary)):1245-1251.
The aim of the current study was to formulate sustain release (SR) tablets of ketoprofen. Five batches (batch I -V) of matrix based ketoprofen tablet were prepared by dry granulation method using hydroxyl propyl methyl cellulose (15000cps). Compatibility of formulation excipients with drug was explored through FT-IR technique. Various physical and chemical parameters of all tablet batches were evaluated with multi-point dissolution profile (for 24hrs) for formulation optimization. Release kinetics of trials was estimated by model dependent and independent methods. Formulations having excellent quality attributes were then compared with marketed ketoprofen SR tablets. Accelerated stability study was also conducted to compute the shelf life of the optimized formulation. FT-IR scans illustrated the compatibility of ketoprofen with all tablet excipients. On the basis of testing results and controlled release pattern batch II was set to be an optimized trial having shelf life of 37 months. All trial batches (batch I-V) and the marketed brand exhibited highest linearity towards zero order and Korsmeyer-Peppas model with non-fickian anomalous transport (n=0.541-0.655).
本研究的目的是制备酮洛芬缓释（SR）片。采用干法制粒法，使用羟丙基甲基纤维素（15000cps）制备了五批（批次I - V）基于基质的酮洛芬片。通过傅里叶变换红外光谱（FT - IR）技术探究了制剂辅料与药物的相容性。通过多点溶出曲线（24小时）评估所有片剂批次的各种物理和化学参数，以优化制剂。通过模型依赖和独立方法估计试验的释放动力学。然后将具有优异质量属性的制剂与市售酮洛芬SR片进行比较。还进行了加速稳定性研究，以计算优化制剂的保质期。FT - IR扫描表明酮洛芬与所有片剂辅料具有相容性。根据测试结果和控释模式，批次II被确定为优化试验，保质期为37个月。所有试验批次（批次I - V）和市售品牌对零级和Korsmeyer - Peppas模型表现出最高的线性关系，具有非菲克反常转运（n = 0.541 - 0.655）。
