Thermal and fractal analysis microparticles obtained by of diclofenac/Gelucire 50/13 ultrasound-assisted atomization

Thermal and fractal analysis microparticles obtained by of diclofenac/Gelucire 50/13 ultrasound-assisted atomization
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DOI:
10.1002/jps.20337
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发表时间:
2005-05-01
影响因子:
3.8
通讯作者:
Fini, A
Fini, A
中科院分区:
医学3区
文献类型:
--
作者:
Cavallari, C;Rodriguez, L;Fini, A

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该研究描述了喷雾凝结技术的应用,使用新型超声辅助雾化器制备双氯芬酸/Gelucire 50/13微粒,目的是在不使用任何溶剂的情况下获得药物与赋形剂比例为10% w/w的增强释放制剂。扫描电镜显示可以得到接近球形且非聚集的微粒;具有良好的封装效率(大多数尺寸分数为 90%)并且普遍粒径在 150-350 μm 范围内。 SEM 图像分析结果和高分形维数表明大多数颗粒实际上具有椭圆形形状和相当粗糙的轮廓。进行热台显微镜、差示扫描量热法和X射线粉末衍射分析来评估由此制备的微粒的固态性质和热行为。体外测试显示,与纯药物和药物/Gelucire 50/13 物理混合物相比,超声微粒中双氯芬酸的溶出率显着增加。 (c) 2005 年 WileyLiss, Inc. 和美国药剂师协会。
The study describes the application of a spray-congealing technique, using a new ultrasound-assisted atomizer to prepare microparticles of diclofenac/Gelucire 50/13, with the aim to obtain a formulation of enhanced-release, at 10% w/w drug-to-excipient ratio, without any employ of solvent. Scanning electron microscopy showed that it was possible to obtain almost spherically shaped and non-aggregated microparticles; with good encapsulation efficiency (90% in most size fraction) and with a prevalent particle size in the range 150-350 mu m. Image analysis results by SEM and the high fractal dimension value suggested that most particles have actually an ellipsoidal shape and a rather rough contour. Hot stage microscopy, differential scanning calorimetry, and X-ray powder diffractometry analysis were carried out to evaluate the nature of the solid state and the thermal behavior of the microparticles thus prepared. The in vitro tests displayed a significant increase of the diclofenac dissolution rate from ultrasound microparticles, compared with pure drug and with drug/Gelucire 50/13 physical mixtures. (c) 2005 WileyLiss, Inc. and the American Pharmacists Association.