在冷过程中的热相互作用的数学建模:对产品形态和干燥行为的影响
Vincenzo Massotti1, Fiora Artusio1, Antonello A Barresi1
1Department of Applied Science and Technology, Politecnico di Torino, 24 corso Duca degli Abruzzi, IT, 10129, Torino, Italy.
概括
在冷干燥过程中,瓶子之间的热相互作用导致批量异质性. 这项研究模拟了热传递如何影响核化温度和结速率,从而导致产品形态变化和相互作用瓶中的更广泛分布.
科学领域:
- 制药科学 制药科学
- 生物工艺工程 生物工艺工程
- 物理化学 物理化学
背景情况:
- 冷干燥 (软化) 对于生物制药的稳定性和保质期至关重要.
- 腹腔产品通常被冷在温度控制的货架上的瓶子里.
- 批量异质性来自于不受控制的核和可变的结速率.
研究的目的:
- 描述冷过程中瓶子相互作用中的热合效应.
- 用数学模型评估热相互作用对冷干燥产品形态的影响.
- 了解瓶子接近如何影响核化温度和结动态.
主要方法:
- 热合在相互作用和非相互作用的小瓶配置的特征.
- 使用热合估计的1D数学模型的开发和应用.
- 对模型对核化温度,结率和产品形态学的预测进行分析.
主要成果:
- 热相互作用显著影响了预测的核化温度,特别是在晚核化瓶中.
- 冷速度也受到瓶间热合的强烈影响.
- 相互作用的瓶子表现出更高的批量异质性,导致更广泛的孔径大小和干燥时间分布.
结论:
- 冷期间的热合导致生物制药批次的异质性增加.
- 开发的模型为冷过程中的瓶热历史提供了有价值的见解.
- 通过考虑瓶相互作用和热合,可以改进冷协议的合理设计.
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