Chivate Amit Ashok, Poddar Sushilkumar Sharatchandra, Abdul Shajahan, Savant Gaurav
Department of Pharmaceutics, Principal K. M. Kundnani College of Pharmacy, Cuffe Parade, Mumbai, 400005, India.
AAPS PharmSciTech. 2008;9(1):197-204. doi: 10.1208/s12249-008-9039-7. Epub 2008 Feb 5.
The purpose of the research was to evaluate Sterculia foetida gum as a hydrophilic matrix polymer for controlled release preparation. For evaluation as a matrix polymer; characterization of Sterculia foetida gum was done. Viscosity, pH, scanning electronmicrographs were determined. Different formulation aspects considered were: gum concentration (10-40%), particle size (75-420 microm) and type of fillers and those for dissolution studies; pH, and stirring speed were considered. Tablets prepared with Sterculia foetida gum were compared with tablets prepared with Hydroxymethylcellulose K15M. The release rate profiles were evaluated through different kinetic equations: zero-order, first-order, Higuchi, Hixon-Crowell and Korsemeyer and Peppas models. The scanning electronmicrographs showed that the gum particles were somewhat triangular. The viscosity of 1% solution was found to be 950 centipoise and pH was in range of 4-5. Suitable matrix release profile could be obtained at 40% gum concentration. Higher sustained release profiles were obtained for Sterculia foetida gum particles in size range of 76-125 microm. Notable influences were obtained for type of fillers. Significant differences were also observed with rotational speed and dissolution media pH. The in vitro release profiles indicated that tablets prepared from Sterculia foetida gum had higher retarding capacity than tablets prepared with Hydroxymethylcellulose K15M prepared tablets. The differential scanning calorimetry results indicated that there are no interactions of Sterculia foetida gum with diltiazem hydrochloride. It was observed that release of the drug followed through surface erosion and anomalous diffusion. Thus, it could be concluded that Sterculia foetida gum could be used a controlled release matrix polymer.
本研究的目的是评估苹婆胶作为用于控释制剂的亲水性基质聚合物。为了评估其作为基质聚合物的性能，对苹婆胶进行了表征。测定了其粘度、pH值和扫描电子显微镜图像。考虑的不同制剂方面包括：胶浓度（10 - 40%）、粒径（75 - 420微米）和填充剂类型，以及用于溶出度研究的pH值和搅拌速度。将用苹婆胶制备的片剂与用羟丙基甲基纤维素K15M制备的片剂进行比较。通过不同的动力学方程评估释放速率曲线：零级、一级、Higuchi、Hixon - Crowell和Korsemeyer及Peppas模型。扫描电子显微镜图像显示胶粒有点呈三角形。发现1%溶液的粘度为950厘泊，pH值在4 - 5范围内。在40%的胶浓度下可获得合适的基质释放曲线。粒径范围在76 - 125微米的苹婆胶颗粒获得了更高的缓释曲线。填充剂类型有显著影响。转速和溶出介质pH值也观察到显著差异。体外释放曲线表明，用苹婆胶制备的片剂比用羟丙基甲基纤维素K15M制备的片剂具有更高的缓释能力。差示扫描量热法结果表明苹婆胶与盐酸地尔硫卓之间没有相互作用。观察到药物的释放遵循表面侵蚀和非正规扩散。因此，可以得出结论，苹婆胶可作为控释基质聚合物使用。
