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首页> 外文期刊>Journal of Microencapsulation: Microcapsules Liposomes Nanoparticles Microcells Microspheres >Formulation optimization of double emulsification method for preparation of enzyme-loaded Eudragit S100 microspheres
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Formulation optimization of double emulsification method for preparation of enzyme-loaded Eudragit S100 microspheres

机译：双乳化法制备酶负载Eudragit S100微球的配方优化

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The present study aimed to develop an oral sustained release microparticulate system for acid labile enzyme-Serratiopeptidase. A 32 full factorial experiment was designed to study the effects of the external aqueous phase volume and stabilizer (Tween~R 80) concentration on the entrapment and size of Eudragit S100 microspheres prepared by a modified double emulsion solvent evaporation technique. The results of analysis of variance tests for both effects indicated that the test is significant. The effect of external aqueous phase volume was found to be higher on the entrapment efficiency of microspheres (SSY_1 = 1362.63; SSY_2 = 250.13), whereas Tween~R 80 produced a significant effect on size of microspheres (SSY_1 =944.01; SSY+2 = 737.26). Scanning electron microscopy of microspheres demonstrated smooth surface spherical particles. The effect of formulation variables on the integrity of enzyme was confirmed by in vitro proteolytic activity. Microspheres having maximum drug encapsulation (81.32 ± 3.97) released 4-5% enzyme at pH 1.2 in 2 h. The release of enzyme from microspheres followed Higuchi kinetics (R~2 = 0.987). In phosphate buffer, microspheres showed an initial burst release of 25.65 ± 2.35% in 1 h with an additional 62.96 ±4.09% release in the next 5h. Thus, formulation optimization represents an economical approach for successful preparation of Eudragit S100 microspheres involving fewest numbers of experiments.
机译：本研究旨在开发一种用于酸不稳定酶-Serratiopeptidase的口服缓释微粒系统。设计了32个全因子实验，研究了外部水相体积和稳定剂（Tween〜R 80）浓度对采用改进的双乳液溶剂蒸发技术制备的Eudragit S100微球的包封和尺寸的影响。两种效果的方差检验分析结果都表明检验是有意义的。发现外部水相体积对微球的包封效率有更高的影响（SSY_1 = 1362.63; SSY_2 = 250.13），而Tween〜R 80对微球的尺寸产生了显着影响（SSY_1 = 944.01; SSY + 2 = 737.26）。微球的扫描电子显微镜显示出光滑的表面球形颗粒。体外蛋白水解活性证实了制剂变量对酶完整性的影响。具有最大药物包封度（81.32±3.97）的微球在2小时内在pH 1.2时释放了4-5％的酶。从微球中释放的酶遵循Higuchi动力学（R〜2 = 0.987）。在磷酸盐缓冲液中，微球在1小时内显示出25.65±2.35％的初始爆发释放，在接下来的5小时内释放了62.96±4.09％的释放。因此，配方优化代表了成功制备Eudragit S100微球的经济方法，涉及最少的实验次数。

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