采用JMP软件进行托法替尼缓释片处方的设计与优化

Design and Optimization of the Formulation of Tofacitinib Sustained-release Tablets with JMP Software

关键词:  托法替尼|参比制剂|片芯|质量源于设计|JMP软件

Key words:  tofacitinib|reference preparation|tablet core|quality by design|JMP software

摘要:

目的 采用JMP软件的实验设计及预测刻画器功能，对托法替尼缓释片的片芯处方进行筛选，探讨JMP软件在片剂处方筛选中的实用性。方法 采用粉末直压工艺，通过实验设计筛选辅料用量，以自制样品与参比制剂片芯溶出曲线的f₂值为指标建立模型，并通过JMP软件的预测刻画器预测最佳处方及溶出结果，对预测的最佳处方结果进行实验验证。结果 实验结果与软件预测结果非常接近。结论 采用JMP软件进行处方设计与预测简单方便，可推广用于药品的处方开发过程。

Abstract:

OBJECTIVE To screen the core formulation of tofacitinib sustained-release tablets by using the experimental design and predictive descriptor function of JMP software, and to explore the practicability of JMP software in tablet prescription screening. METHODS The powder direct compression process was adopted, the amount of excipients was screened through the experimental design, and the f₂ value of the dissolution curve of the self-made sample and the reference tablet core was used as an indicator to establish a model. Moreover, the prediction profiler of the JMP software was used to find the optimal formulation and dissolution result, and the predicted optimal formulation result was verified. RESULTS The actual test results were very close to the software prediction results. CONCLUSION The use of JMP software to design and predict formulation is simple and convenient, the prescription development process for drugs can be promoted.