工艺参数对连续混合工艺的影响,近红外光谱在线监测
Rute C Dias1, Ossi Korhonen2, Jarkko Ketolainen2
1PromisLab, School of Pharmacy, University of Eastern Finland, 70211 Kuopio, Finland; iMed.ULisboa, Faculty of Pharmacy, University of Lisbon, 1649-003 Lisbon, Portugal.
概括
推进器速度显著影响连续粉末混合均性,通过近红外光谱 (NIRS) 监测. 优化螺旋速度和料率可以提高混合预测的准确性,以提高质量制造.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 过程分析技术 (PAT) 是一种分析技术.
背景情况:
- 连续制造确保药品生产中产品质量的一致性.
- 近红外光谱 (NIRS) 提供了粉末混合物中关键质量属性的实时监测.
研究的目的:
- 为了研究总料速率和叶轮转速对连续粉末混合的影响.
- 评估NIRS在线监测混合物统一性的有效性.
主要方法:
- 使用因数实验设计来研究过程参数.
- 使用了统计分析,包括主要组件分析 (PCA),ANOVA同时组件分析 (ASCA) 和部分最小平方 (PLS) 回归.
- 近红外光谱学 (NIRS) 用于实时在线评估.
主要成果:
- 驱动器速度被确定为影响光谱变异 (55.5%) 和布洛芬度的主要因素,归因于粉末流化效应.
- 驱动器速度和总料率都显示出具有统计学意义的影响 (p=0.004).
- 一个部分最小平方 (PLS) 回归模型实现了1.3%的交叉验证 (RMSECV) 的根平均平方误差 (wt/wt) 对于ibuprofen含量预测.
结论:
- 低转速 (<600rpm) 和低料速率 (<15kg/h) 优化NIRS探头呈现,以提高混合预测.
- 驱动器速度对光谱数据产生主导,波长依赖的影响,影响混合物均性.
- 优化的工艺参数提高了NIRS在连续制药生产中的可靠性.
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