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战略化喷雾干燥工艺优化,用于制造可再分散的甲纳米颗粒,使用质量设计原则

Vishal Rathod^1,2, Bhavin Gajera¹, Anusha Pinninti¹

¹Division of Pharmaceutics Sciences, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, The Long Island University, Brooklyn, New York, 11201, USA.

AAPS PharmSciTech

|June 8, 2023

概括

使用设计质量原则的喷雾干燥印米他辛纳米悬浮改善了药物释放. 这项研究优化了提高再分散性和产量的参数,证实了粒子完整性和配方稳定性.

科学领域:

制药技术制药技术制药技术
材料科学材料科学材料科学
化学工程是化学工程的重要组成部分.

背景情况:

印美甲纳米悬浮剂 (IMC-NS) 需要优化干燥,以提高治疗疗效.
喷雾干燥是纳米粒子配方的关键过程,影响药物释放和稳定性.
设计质量 (QbD) 为流程开发和优化提供了一种系统的方法.

研究的目的:

使用设计质量 (QbD) 方法开发和优化印米他辛喷雾干燥纳米悬浮剂 (IMC-SD-NS).
评估喷雾干燥参数对IMC-SD-NS的关键质量属性 (CQAs) 的影响.
描述优化的IMC-SD-NS的物理化学特性和体外溶解.

主要方法:

使用盒式设计 (BBD) 来研究入口温度,吸入速率和料速率对CQAs的影响.
应用回归分析和ANOVA来识别重要的过程变量并开发预测模型.
使用X射线粉末衍射 (XRPD),富里埃变换红外光谱学 (FTIR) 和体外溶解研究来表征IMC-SD-NS.

主要成果:

喷雾干燥参数显著影响了再分散度指数 (RDI),百分比产量和15分钟后释放的百分比.
开发的CQA预测模型具有统计学意义 (p < 0.05).
优化的IMC-SD-NS表现出维持晶体状态,没有药物辅助物相互作用,药物释放量增加了3.82倍.

结论:

一种基于QbD的方法有效地优化了印米他纳米悬浮的喷雾干燥.
开发的IMC-SD-NS证明了纳米颗粒的增强溶解速率.
实验设计 (DoE) 对于开发纳米粒子配方的强大高效喷雾干燥工艺至关重要.

关键词:

这是一个ANOVA,一个ANOVA.美国能源部 (DoE)在QbD中,它是QbD.多重线性回归的多重线性回归.这是一种纳米悬浮.纳米技术是纳米技术.喷雾干燥喷雾干燥

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