Ranchhodbhai Patel Hitesh, Manordas Patel Madhabhai
Department of Pharmaceutical Technology, S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Gujarat, India.
Iran J Pharm Res. 2010 Winter;9(1):21-6.
The aim of the present study was to prepare and evaluate an osmotically controlled mucoadhesive cup-core (OCMC) containing aceclofenac. A special technique was used while preparing an OCMC. Stability of OCMC was determined in natural human saliva, and it was found that both pH and device are stable in human saliva. OCMC was evaluated by weight uniformity, thickness, hardness, friability, swelling, mucoadhesive strength and in vitro drug release. Swelling index was higher with formulations containing hydroxypropyl methylcellulose (HPMC) K4M alone, and it decreases with its decreasing concentration in the OCMC. The in vitro drug release studies showed a release with the composition of formulation up to 12 h. The mechanism of drug release was found to be zero order kinetics with diffusion controlled drug release. It has shown significant anti-inflammatory activity (P<0.001) and no hypersensitive reaction. It can be concluded that by changing the content of OCMC system, a desire effect is generated and it overcomes the drawback associated with the conventional buccal adhesive tablet.
本研究的目的是制备并评估一种含有醋氯芬酸的渗透控释粘膜粘附杯芯制剂（OCMC）。制备OCMC时采用了一种特殊技术。在天然人唾液中测定了OCMC的稳定性，发现其pH值和制剂在人唾液中均稳定。通过重量均匀度、厚度、硬度、脆碎度、溶胀度、粘膜粘附强度和体外药物释放对OCMC进行了评估。单独含有羟丙基甲基纤维素（HPMC）K4M的制剂溶胀指数较高，其在OCMC中的浓度降低时溶胀指数会下降。体外药物释放研究表明，制剂组成在12小时内持续释放药物。发现药物释放机制为零级动力学且药物释放受扩散控制。它显示出显著的抗炎活性（P<0.001）且无过敏反应。可以得出结论，通过改变OCMC系统的含量，可以产生预期效果并克服传统口腔粘附片相关的缺点。
