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首页> 外文期刊>Crystal growth & design >Population Balance Model Development Verification and Validation of Cooling Crystallization of Carbamazepine
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Population Balance Model Development Verification and Validation of Cooling Crystallization of Carbamazepine

机译：人口平衡模型开发验证和验证卡马抑素的冷却结晶

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摘要

Using process modeling to understand process dynamics and potentially explore the design space of a crystallization process is difficult because of its complex nature with many factors at play, such as initial concentration, supersaturation, seeding strategy, and flow pattern. In this work, a systematic approach is applied to sequentially estimate the growth and nucleation rate of the cooling crystallization of carbamazepine at various conditions in batch operation. Different formulations of the kinetic expressions are tested as a model discrimination exercise to obtain the best fit with the most confidence form. Then, based on the risk, determined by the purpose of the obtained model, verification and validation activities are applied. The model is verified and validated to predict concentration and D50 for a specific seeding strategy for crystallization mechanisms, including both nucleation and growth, are highly dependent on the seed PSD. A brief discussion is also given on the transferring of the batch-developed model to continuous operations in response to the growing interest in continuous crystallization development. It is found that the model can be transferred to continuous operations where the supersaturation and solid concentration are similar to those tested during batch experimentation. Because of the complex and interactive effects of supersaturation and solid conditions on crystallization kinetics, it is reasonable to conclude that in order to infer transferable crystallization kinetics, batch experimental conditions must be wide and similar enough to cover the potential continuous operating space.
机译：使用流程建模来了解过程动态并可能探索结晶过程的设计空间是困难的，因为其在游戏中具有许多因素的复杂性，例如初始浓度，超饱和，种子策略和流动模式。在这项工作中，应用系统方法以依次估计在分批操作中各种条件下尿嘧啶的冷却结晶的生长和成核速率。动力学表达的不同配方被测试为模型歧视练习，以获得最有信心的最佳拟合。然后，根据风险，由所获得的模型的目的决定，应用验证和验证活动。验证模型并验证以预测用于结晶机制的特定种子策略的浓度和D50，包括核心和生长，高度依赖于种子PSD。还介绍了在响应于连续结晶发育的越来越兴趣的兴趣持续运作的批量开发的模型。发现该模型可以转移到连续的操作，其中过饱和度和固体浓度类似于在分批实验期间测试的那些。由于在结晶动力学上过饱和和固体条件的复合物和互动性，得出结论是合理的，以便推断可转移的结晶动力学，批量实验条件必须宽且足以覆盖潜在的连续操作空间。

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  • 来源
    《Crystal growth & design》 |2020年第8期|共16页
  • 作者

    Liu Yiqing C.; Acevedo David; Yang Xiaochuan; Naimi Sean; Wu Wei-Lee; Pavurala Naresh; Nagy Zoltan K.; OConnor Thomas F.;

  • 作者单位

    US FDA Off Pharmaceut Qual Ctr Drug Evaluat &

    Res Silver Spring MD 20993 USA;

    US FDA Off Pharmaceut Qual Ctr Drug Evaluat &

    Res Silver Spring MD 20993 USA;

    US FDA Off Pharmaceut Qual Ctr Drug Evaluat &

    Res Silver Spring MD 20993 USA;

    US FDA Off Pharmaceut Qual Ctr Drug Evaluat &

    Res Silver Spring MD 20993 USA;

    US FDA Off Pharmaceut Qual Ctr Drug Evaluat &

    Res Silver Spring MD 20993 USA;

    US FDA Off Pharmaceut Qual Ctr Drug Evaluat &

    Res Silver Spring MD 20993 USA;

    Purdue Univ Davidson Sch Chem Engn W Lafayette IN 47907 USA;

    US FDA Off Pharmaceut Qual Ctr Drug Evaluat &

    Res Silver Spring MD 20993 USA;

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  • 正文语种 eng
  • 中图分类 晶体学;
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