Karmarkar A B, Gonjari I D, Hosmani A H, Dhabale P N
Govt. College of Pharmacy, Karad-415124, Dist. Satara, MS, India.
Drug Discov Ther. 2010 Feb;4(1):26-32.
The aim of the present work was to prepare and evaluate sustained release liquisolid compact formulations of tramadol hydrochloride. The dissolution profile of the prepared compacts was also compared to that of a marketed preparation. Liquisolid sustained release formulations were prepared by using HPMC K4M as a sustained release agent. Precompression studies of characteristics such as flow properties were also carried out. Liquisolid compacts were evaluated by hardness, friability, and in vitro dissolution studies. Comparison of dissolution profiles was carried out by using a modelindependent, model-dependent, and statistical approach. The prepared liquisolid compacts are new dosage forms with better sustained release behavior compared to a marketed sustained formulation. The dissolution profile followed the Peppas model as "best fit" model. Two-way ANOVA results revealed a significant difference in dissolution profiles. This systematic approach to producing a formulation was found to help with analyzing the sustained release of tramadol hydrochloride. The use and evaluation of model-dependent methods is more complicated. These methods provide an acceptable model approach that indicates the true relationship between percent drug release and time variables, including statistical assumptions.
本研究的目的是制备并评估盐酸曲马多的缓释液固型制剂。还将所制备制剂的溶出曲线与市售制剂的溶出曲线进行了比较。采用羟丙甲纤维素K4M作为缓释剂制备液固型缓释制剂。还进行了诸如流动性等特性的压片前研究。通过硬度、脆碎度和体外溶出研究对液固型片剂进行评估。采用非模型依赖、模型依赖和统计方法对溶出曲线进行比较。与市售缓释制剂相比，所制备的液固型片剂是具有更好缓释行为的新剂型。溶出曲线以Peppas模型作为“最佳拟合”模型。双向方差分析结果显示溶出曲线存在显著差异。发现这种制备制剂的系统方法有助于分析盐酸曲马多的缓释情况。模型依赖方法的使用和评估更为复杂。这些方法提供了一种可接受的模型方法，表明了药物释放百分比与时间变量之间的真实关系，包括统计假设。
