使用罗望子胶羧甲基化产物，通过挤出滚圆技术，采用析因设计法制备兰索拉唑微丸的处方筛选与优化
Formulation and Optimization of Lansoprazole Pellets Using Factorial Design Prepared by Extrusion-Spheronization Technique Using Carboxymethyl Tamarind Kernel Powder.
作者信息
Muley Sagar Sopanrao, Nandgude Tanaji, Poddar Sushilkumar
机构信息
Dept. of Pharmaceutics, D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pune University, Pimpri, Pune, Maharashtra, India.
Departmment of Pharmaceutics, Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune, Maharashtra 411018, India.
出版信息
Recent Pat Drug Deliv Formul. 2017;11(1):54-66. doi: 10.2174/1872211311666170113150248.
BACKGROUND
In the present study, Lansoprazole pellets were prepared employing a novel excipient Carboxymethyl tamarind kernel powder (CMTKP) using extrusion-spheronization technique. Various research studies including patents have been carried out on this polymer. Pellet formulation was optimized for formulation parameters (concentration of microcrystalline cellulose, CMTKP, croscarmellose sodium and isopropyl alcohol).
METHODS
Process parameters (speed and duration of spheronization) were optimized using factorial design. The pellets were evaluated for yield, bulk and tapped density, particle size, hardness, drug content, disintegration time and drug release.
RESULTS
The optimized batch showed 93.53% yield, 0.307 kg/cm2 hardness, 2.15 mm average particle size, 292 sec disintegration time and 90.46% drug content.
CONCLUSION
Drug release of the optimized batch (2F7) and marketed formulation (LANZOL cap) was found to be 82.33% and 80.07%, respectively. An accelerated study indicated that optimized formulation was stable.
背景
在本研究中，采用新型辅料羧甲基罗望子胶核粉（CMTKP），通过挤出滚圆技术制备兰索拉唑微丸。针对这种聚合物已经开展了包括专利在内的各种研究。对微丸制剂的配方参数（微晶纤维素、CMTKP、交联羧甲基纤维素钠和异丙醇的浓度）进行了优化。
方法
采用析因设计对工艺参数（滚圆速度和持续时间）进行优化。对微丸的收率、堆密度和振实密度、粒径、硬度、药物含量、崩解时间和药物释放进行评估。
结果
优化后的批次收率为93.53%，硬度为0.307 kg/cm²，平均粒径为2.15 mm，崩解时间为292秒，药物含量为90.46%。
结论
优化批次（2F7）和市售制剂（LANZOL胶囊）的药物释放率分别为82.33%和80.07%。加速试验表明优化后的制剂是稳定的。
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