通过设计方法在质量之后开发低熔点API的纳米晶体制剂

湿介质研磨和喷雾干燥的纳米晶制剂的制备是一种可靠的技术,以增强可溶性BCS II药物差的溶解和改善吸收限制。然而,当热敏组合物在高温下干燥时,必须考虑颗粒聚集和热降解的风险。

本研究研究了纳米悬浮液配方变量在喷雾干燥过程中在熔点以上和以下等距温度下的影响。为此目的,非诺贝特被开发为一种不良的药代动力学特征和低熔点(79-82°C)的模型药物,这些特性使得热加工成为一项重要任务。通过将分子模拟与QbD方法相结合,使系统的行为合理化,可以“操纵”稳定纳米晶体的制备,以避免不良的熔化。

The statistically resolved operational conditions showed that Fenofibrate Critical Quality Attribute–compliant nanosuspensions i.e., bearing hydrodynamic diameter and ζ-potential of 887 nm and −16.49 mV, respectively, were obtained by wet milling drug to Pharmacoat and mannitol weighted optimum ratios of 4.075% and 0.75%, after spray drying at the desired temperature of 77 °C. In conclusion, we present a quality assurance methodology of nano-comminution generally applicable for thermo-labile BCS II drugs.

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文章信息:Ouranidis, a;Gkampelis:;我知道,c;Nikolakakis i;低熔点API纳米晶体配方的开发遵循设计的质量方法。流程2021.9.,954. https://doi.org/10.3390/pr9060954

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