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首页> 外文期刊>Pharmaceutical development and technology >Box-Behnken study design for optimization of bicalutamide-loaded nanostructured lipid carrier: stability assessment
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Box-Behnken study design for optimization of bicalutamide-loaded nanostructured lipid carrier: stability assessment

机译：Box-Behnken研究设计，用于优化比卡鲁胺装载的纳米结构脂质载体的稳定性评估

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Bicalutamide (BCM) is an anti-androgen drug used to treat prostate cancer. In this study, nanostructured lipid carriers (NLCs) were chosen as a carrier for delivery of BCM using Box-Behnken (BB) design for optimizing various quality attributes such as particle size and entrapment efficiency which is very critical for efficient drug delivery and high therapeutic efficacy. Stability of formulated NLCs was assessed with respect to storage stability, pH stability, hemolysis, protein stability, serum protein stability and accelerated stability. Hot high-pressure homogenizer was utilized for formulation of BCM-loaded NLCs. In BB response surface methodology, total lipid, % liquid lipid and % soya lecithin was selected as independent variable and particle size and % EE as dependent variables. Scanning electron microscopy (SEM) was done for morphological study of NLCs. Differential scanning calorimeter and X-ray diffraction study were used to study crystalline and amorphous behavior. Analysis of design space showed that process was robust with the particle size less than 200nm and EE up to 78%. Results of stability studies showed stability of carrier in various storage conditions and in different pH condition. From all the above study, it can be concluded that NLCs may be suitable carrier for the delivery of BCM with respect to stability and quality attributes.
机译：比卡鲁胺（BCM）是用于治疗前列腺癌的抗雄激素药物。在这项研究中，使用Box-Behnken（BB）设计选择了纳米结构脂质载体（NLC）作为BCM的载体，以优化各种质量属性，例如粒径和包封效率，这对于有效的药物递送和高度治疗至关重要功效。就储存稳定性，pH稳定性，溶血性，蛋白稳定性，血清蛋白稳定性和加速稳定性方面评估配制的NLC的稳定性。使用热高压均质机配制载有BCM的NLC。在BB响应面方法中，总脂质，液体脂质％和大豆卵磷脂百分比被选为自变量，颗粒大小和EE百分比被选为因变量。进行了扫描电子显微镜（SEM）以用于NLC的形态学研究。差示扫描量热仪和X射线衍射研究用于研究晶体和非晶态行为。对设计空间的分析表明，该工艺鲁棒性好，粒径小于200nm，EE高达78％。稳定性研究的结果表明载体在各种储存条件和不同pH条件下的稳定性。从以上所有研究中可以得出结论，就稳定性和质量属性而言，NLC可能是BCM输送的合适载体。

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