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首页> 外文期刊>Journal of drug delivery science and technology >Quality-by-design model in optimization of PEG-PLGA nano micelles for targeted cancer therapy
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Quality-by-design model in optimization of PEG-PLGA nano micelles for targeted cancer therapy

机译：PEG-PLGA纳米胶束优化的质量设计模型，用于靶向癌症治疗

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Poly (D,L-Lactic-co-Glycolic acid) (PLGA) is a biodegradable and biocompatible polymer approved by FDA for clinical uses. Surface functionalization of self-assembly micelles made of PLGA with Poly-Ethylene Glycol (PEG) improves its stability and half-life in blood circulation via inhibiting adsorption of proteins on the surface and consequently decreasing opsonisation rate. The purpose of present study was to optimize PEG amount absorbed on PLGA (PEGabsPLGA) micelles by application of quality by design approach. Based on risk assessment, effect of three variables including PLGA concentration, PEG concentration and molecular weight (MW) of PLGA were studied. Central composite design was implemented for design of experimentation with 26 runs. The PEGabsPLGA nano drug delivery system (NDDS), produced by o/w method, was optimized according to particle size, polydispersity index (PDI) and zeta potential values. Validation of the model was successfully performed with three representative formulations from the design space. As a result, 43.79 mg of PLGA with MW of 30,000-60,000 was incorporated with 12.61 mg of PEG to obtain a 69 nm NDDS (predicted 67.72 nm) with the PDI value equal to 0.124 (predicted 0.112). The results successfully led to the preparation of the most stable nanoparticles which were stable at room temperature for six months.
机译：聚（D，L-乳酸 - 共乙醇酸）（PLGA）是经FDA批准的可生物降解和生物相容性的聚合物，用于临床用途。用聚乙二醇（PEG）由PLGA制成的自组装胶束的表面官能化通过抑制表面上的蛋白质的吸附并因此降低了检索声率来改善其血液循环中的稳定性和半衰期。目前研究的目的是通过设计方法应用质量来优化在PLGA（PEGABSPLGA）胶束上吸收的PEG量。基于风险评估，研究了包括PLGA浓度，PEG浓度和分子量（MW）的三种变量的效果。为26次运行设计，实施了中央复合设计。通过O / W方法生产的Pegabsplga纳米药物递送系统（NDDS）根据粒度，多分散指数（PDI）和Zeta电位值进行优化。使用来自设计空间的三种代表制剂成功地执行模型的验证。结果，43.79mg具有30,000-60,000的MW的PLGA掺入，加入12.61mg PEG，得到69nm NDDS（预测67.72nm），PDI值等于0.124（预测0.112）。结果成功地导致制备最稳定的纳米颗粒，其在室温下稳定六个月。

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