Clobetasol propionate solid lipid nanoparticles cream for effective treatment of eczema: formulation and clinical implications.
Clobetasol propionate solid lipid nanoparticles cream for effective treatment of eczema: formulation and clinical implications.
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丙酸氯倍他索固体脂质纳米粒子乳膏有效治疗湿疹：配方和临床意义。
DOI：
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发表时间：
2005
影响因子：
0.6
通讯作者：
A. Misra
中科院分区：
文献类型：
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作者：
Mayurkumar Kalariya;B. Padhi;M. Chougule;A. Misra
在本研究中，丙酸氯倍他索（Cp）作为固体脂质纳米粒（SLN）装载，将其掺入合适的乳膏基质中，并在体外评价其临床性能，与等效的市售制剂相比。通过高压均质化技术将Cp掺入SLN中，并以平均粒径、表面形态和药物包封率为特征。在经验证的Franz静态扩散池中，通过人尸体皮肤（HCS）进行Cp乳膏的药物渗透和皮肤吸收研究。16例慢性湿疹患者参加了一项对照双盲临床试验。优化后的Cp-SLN在扫描电镜下为光滑球形，平均粒径为177 nm，药物包封率为92.05%。体外渗透研究显示，与市售药物乳膏相比，Cp-SLN乳膏的Cp平均通量值较低，皮肤吸收较高。发现两种制剂对慢性湿疹的表现都有反应，而本研究中制备的Cp-SLN乳膏在炎症和瘙痒程度降低百分比方面与市售乳膏相比，治疗反应显著改善（1.9倍;炎症，1.2倍;瘙痒）。需要进一步的临床试验来确定本制剂的有效性。
In the present study clobetasol propionate (Cp) was loaded as solid lipid nanoparticles (SLN), incorporated it in suitable cream base and evaluated in vitro and its performance clinically against equivalent marketed formulation. Cp was incorporated into SLN by high-pressure homogenization technique and characterized for mean particle size, surface morphology and per cent drug entrapment. Drug permeation and skin uptake studies from Cp creams were carried out in a validated Franz static diffusion cell across human cadaver skin (HCS). Sixteen chronic eczema patients were enrolled in a controlled double blind clinical trial. Optimized Cp-SLN was smooth and spherical under scanning electron microscopy; with average particle size of 177 nm and per cent drug entrapment of 92.05%. In vitro permeation studies revealed lower mean flux value and higher skin uptake of Cp from Cp-SLN cream compared to marketed drug cream. Both formulations were found to be responsive to manifestations of chronic eczema, while Cp-SLN cream prepared in this investigation registered significant improvement in therapeutic response (1.9 fold; inflammation, 1.2 fold; itching) in terms of per cent reduction in degree of inflammation and itching against marketed cream. Further clinical trials are required to ascertain the efficiency of the present formulation.