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Kensaku Matsunami1, Alexander Ryckaert1, Hanne Verrecas2

  • 1Pharmaceutical Engineering Research Group (PharmaEng), Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, Ghent 9000 Oost-Vlaanderen, Belgium.

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概括
此摘要是机器生成的。

这项研究表明,批量试验可以预测连续制造的药片溶解. 这种方法促进了连续直接压缩 (CDC) 片生产的高效工艺设计.

关键词:
连续制造 连续制造制造数据驱动模型是基于数据的模型.直接压缩直接压缩.溶解测试是一种溶解测试.相似性因子相似性因子药片 药片 药片 药片 是一种药片.可转让性 可转让性

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科学领域:

  • 制药制造业 制药制造业 制药制造业
  • 工艺工程是过程工程.
  • 药物运输 药物运输 药物运输

背景情况:

  • 连续制造比批量加工具有优势,但需要早期采用工业设备.
  • 批量工艺需要广泛的扩展研究,连续工艺可以规避这一点.
  • 使用批量试验用于早期设计,可以简化过渡到连续制造.

研究的目的:

  • 通过批量和连续直接压缩 (CDC) 方法生产的药片的溶解行为进行比较.
  • 评估批量试验数据的可转移性,用于设计连续制造工艺.
  • 评估基于批量数据的连续制造的预测模型.

主要方法:

  • 使用批量和CDC方法制造具有布洛芬的即时释放片.
  • 实验设计 (DOE) 方法具有多样化的配方特性和抗拉强度.
  • 用相似度因子 (f2) 分析溶解行为,使用微布尔建模与局部最小平方 (PLS) 回归和高斯过程回归 (GPR).

主要成果:

  • 在配方和抗拉强度相匹配时,在批量和CDC片之间观察到相同的溶解概况.
  • 溶解的偏差主要归因于实际抗拉强度的变化.
  • 仅在批量数据上训练的高斯过程回归 (GPR) 模型准确地预测了CDC溶解概况 (平均R2 = 0.910).

结论:

  • 批量试验可以有效地预测通过连续直接压缩 (CDC) 制造的药片的溶解行为.
  • 批量数据的可转移性得到证实,使得可靠的配方和工艺设计可用于连续制造.
  • 这种方法提高了开发固体剂型连续制造工艺的效率.