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首页> 美国卫生研究院文献>Pharmaceutics >Formulation Optimization of Sustained-Release Ammonio Methacrylate Copolymer Microspheres. Effects of Log P and Concentration of Polar Cosolvents and Role of the Drug/Copolymer Ratio
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Formulation Optimization of Sustained-Release Ammonio Methacrylate Copolymer Microspheres. Effects of Log P and Concentration of Polar Cosolvents and Role of the Drug/Copolymer Ratio

机译：甲基丙烯酸甲酯铵盐缓释共聚物微球的配方优化。 Log P和极性助溶剂浓度的影响以及药物/共聚物比率的作用

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摘要

The objectives of this work were the formulation optimization of the preparation process parameters and to evaluate spray-dried sustained-release microspheres using ammonio methacrylate copolymer (AMC) as a polymer matrix. The effects of log P and the concentrations of the cosolvents (acetone, methyl ethyl ketone and n-butyl acetate) and different drug/copolymer ratios as independent variables on the physicochemical parameters (the W1/O emulsion viscosity, the microsphere production yield, the average particle size, the encapsulation efficiency) and the cumulative in vitro drug release as dependent variables were studied. The optimization was carried out on the basis of the 33 factorial design study. The optimization process results showed that addition of polar cosolvents proved effective, linear relationships were observed between the independent and the dependent variables. The best conditions were achieved by microspheres prepared by using a low/medium cosolvent log P, cosolvent concentration of 25–50% v/v and a drug/copolymer ratio of 1:16. The microspheres ensured sustained release with Nernst and Baker-Lonsdale release profiles.
机译：这项工作的目的是优化制备工艺参数，并使用甲基丙烯酸铵共聚物（AMC）作为聚合物基质来评估喷雾干燥的缓释微球。 log P和助溶剂（丙酮，甲乙酮和乙酸正丁酯）的浓度以及不同的药物/共聚物比例对理化参数（W1 / O乳液粘度，微球产量，研究了平均粒径，包封效率和体外累积药物释放等因变量。优化是在3 3 析因设计研究的基础上进行的。优化过程结果表明，极性助溶剂的添加被证明是有效的，在自变量和因变量之间观察到线性关系。通过使用低/中助溶剂log P，助溶剂浓度为25–50％v / v和药物/共聚物比率为1:16制备的微球可以达到最佳条件。微球确保了Nernst和Baker-Lonsdale释放曲线的持续释放。

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