Effect of HPMC and ethyl cellulose polymeric granules and its combinations in press coated tablets of lornoxicam: fabrication and in vitro characterization

S. Dineshmohan, V. Gupta, A. Ramesh, V. Harika, T. Sravani
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引用次数: 3

Abstract

The main objective of the present exploration was to formulate and evaluate chronomodulated press-coated tablets to deliver the NSAID lornoxicam, when a pain in the joints, functional disability persist in the early morning time is typically observed in most Rheumatoid arthritis (RA) patients. Pre formulation studies and drug excipient compatibility studies were carried out for lornoxicam and excipients. Core tablets containing lornoxicam was prepared by direct compression method and the tablets were subjected to various pre-compression and post-compression parameters (C1-C4 formula) based on the above result best core tablet batch was selected and used for press coating processes. HPMC and EC granules were used as controlled release polymers in the outer layer. These tablets were subjected to pre and post compression parameters, finally the tablets were evaluated for lag time and in vitro dissolution. Results of preformulation studies were acceptable limits. No interaction was observed between lornoxicam and excipients by FTIR. The results of pre and post compression studies were within limits. Formulation code CC3 was identified as best formulation that extends a release profile with 6 h lag time followed by complete lornoxicam release after 8 h. From the graphical representation it can be well perceive that this is perfectly fit in to Korsemeyer which had a Regression coefficient (R 2 ) of 0.9431. The results of the in-vitro release data of this layer were fitted to the Korsemeyer-Peppas equation to examine the release pattern of the drug from the polymeric system. The drug release was identified as super case II transport as the “n” value found to be more than 0.89. Dineshmohan et al., International Current Pharmaceutical Journal, September 2015, 4(10): 447-452
HPMC与乙基纤维素聚合物颗粒及其组合在氯诺昔康压片中的作用:制备及体外表征
本研究的主要目的是在大多数类风湿关节炎(RA)患者中,当关节疼痛和功能障碍持续存在于清晨时,制定和评估时间调节压片来递送非甾体抗炎药氯诺昔康。对氯诺昔康及其辅料进行了制剂前研究和药物辅料配伍研究。采用直接压缩法制备氯诺昔康芯片,并在此基础上对所制片剂进行预压缩和后压缩参数(C1-C4配方)的优化,选择最佳芯片批次进行压包工艺。外层采用HPMC和EC颗粒作为控释聚合物。对这些片剂进行压缩前后的参数测定,最后对片剂的滞后时间和体外溶出度进行评价。预制剂研究的结果是可接受的限度。FTIR未观察到氯诺昔康与辅料之间的相互作用。压缩前和压缩后的研究结果在限制范围内。处方代码CC3为最佳处方,其缓释时间为6 h,氯诺西康在8 h后完全释放。从图中可以很好地看出,其与Korsemeyer完全吻合,其回归系数(r2)为0.9431。将该层的体外释放数据拟合到korsemyer - peppas方程,以考察药物在聚合物体系中的释放模式。当“n”值大于0.89时,将药物释放确定为超级病例II转运。Dineshmohan等,国际药学杂志,2015,4(10):447-452
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