Zaid Abdel Naser
College of Pharmacy, An Najah National University, Nablus, Palestine.
Pak J Pharm Sci. 2012 Jan;25(1):59-64.
This study was aimed to develop a stable enteric coated diclofenac sodium tablets using Sureteic without a subcoating layer. Diclofenac uncoated tablets were developed and manufactured through the non direct compression process. Sureteric white aqueous coating dispersion was used as enteric coating material. Sureteric is a special mixture of Polyvinyl Acetate Phthalate (Phthalavin (R), PVAP), plasticizers and other ingredients in a suitable optimized dry powder formulation. The obtained enteric coated tablets were subjected to disintegration and no sign of cracking was observed when they placed in a hydrochloric solution at pH 1.2, but they were completely disintegrated within 10 minutes when they putted in buffered solution at pH6.8. Dissolution test was also conducted by placing tablets in 0.1 M HCl for 2 hours and then 1 hour in phosphate buffer at pH 6.8. Less than 0.9% of drug was released in the acidic phase and up to 97% in the basic medium. These results show that Sureteric can be successfully used to produce diclofenac sodium enteric coated tablets in order to prevent its release in the stomach and facilitate immediate release of the drug in the duodenum. These findings suggest that aqueous enteric coating with Sureteric system is an easy and economical approach for preparing stable diclofenac sodium enteric coat without the use of a subcoating layer.
本研究旨在开发一种使用Sureteric且无隔离层的稳定的双氯芬酸钠肠溶片。未包衣的双氯芬酸片通过非直接压片工艺进行研制和生产。Sureteric白色水性包衣分散体用作肠溶包衣材料。Sureteric是聚醋酸乙烯邻苯二甲酸酯（酞酸乙烯（R），PVAP）、增塑剂和其他成分在合适的优化干粉配方中的特殊混合物。将制得的肠溶片进行崩解试验，当置于pH 1.2的盐酸溶液中时未观察到开裂迹象，但当置于pH 6.8的缓冲溶液中时，它们在10分钟内完全崩解。溶出度试验也是通过将片剂置于0.1 M HCl中2小时，然后在pH 6.8的磷酸盐缓冲液中放置1小时来进行的。在酸性阶段药物释放量低于0.9%，在碱性介质中高达97%。这些结果表明，Sureteric可成功用于生产双氯芬酸钠肠溶片，以防止其在胃中释放并促进药物在十二指肠中立即释放。这些发现表明，采用Sureteric体系进行水性肠溶包衣是一种制备稳定的双氯芬酸钠肠溶衣且无需使用隔离层的简便且经济的方法。
