Arno Enose Appavoo, Anand Prithiviraj, Bhaskar Kesavan, Ramachandran Somasundaram, Saravanan Muniyandy, Vinod Radhakrishnan
Department of Pharmaceutics, Vel's College of Pharmacy, Old Pallavaram, Chennai, India.
Chem Pharm Bull (Tokyo). 2002 Nov;50(11):1495-8. doi: 10.1248/cpb.50.1495.
Metformin/Gliclazide extended release tablets were formulated with Eudragit NE30D by wet granulation technique. Two batches were prepared in order to study influence of drug polymer ratio on the tablet formation and in vitro drug release. The formulated tablets were characterized by disintegration time, hardness, friability, thickness, weight variation, and in vitro drug release. The percentage of polymer, with respect to Metformin/Gliclazide, required to produce tablets with acceptable qualities was 9 to 13.45. The percentage of polymer below this range released the drug immediately and above this range produced granules not suitable for tablet formation. The quantity of Metformin/Gliclazide present in the tablets and the release medium were estimated by a validated HPLC method. The formulated tablets had acceptable physicochemical characters and released the drug over 6-8 h. The data obtained from in vitro release studies were fitted with various kinetic models and was found to follow Higuchi kinetics.
二甲双胍/格列齐特缓释片采用Eudragit NE30D通过湿法制粒技术制备。制备了两批片剂，以研究药物与聚合物比例对片剂成型和体外药物释放的影响。对制得的片剂进行崩解时间、硬度、脆碎度、厚度、重量差异和体外药物释放等方面的表征。制备出质量合格片剂所需的聚合物（相对于二甲双胍/格列齐特）百分比为9%至13.45%。低于此范围的聚合物百分比会使药物立即释放，而高于此范围则会产生不适于压片的颗粒。片剂中二甲双胍/格列齐特的含量以及释放介质通过经过验证的高效液相色谱法进行测定。制得的片剂具有可接受的理化性质，药物释放时间为6 - 8小时。体外释放研究获得的数据与各种动力学模型拟合，发现符合 Higuchi 动力学。
