Feed factor profile prediction model for two-component mixed powder in the twin-screw feeder

IF 5.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY International Journal of Pharmaceutics: X Pub Date : 2024-03-31 DOI:10.1016/j.ijpx.2024.100242
Yuki Kobayashi , Sanghong Kim , Takuya Nagato , Takuya Oishi , Manabu Kano
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Abstract

In continuous pharmaceutical manufacturing processes, it is crucial to control the powder flow rate. The feeding process is characterized by the amount of powder delivered per screw rotation, referred to as the feed factor. This study aims to develop models for predicting the feed factor profiles (FFPs) of two-component mixed powders with various formulations, while most previous studies have focused on single-component powders. It further aims to identify the suitable model type and to determine the significance of material properties in enhancing prediction accuracy by using several FFP prediction models with different input variables. Four datasets from the experiment were generated with different ranges of the mass fraction of active pharmaceutical ingredients (API) and the powder weight in the hopper. The candidates for the model inputs are (a) the mass fraction of API, (b) process parameters, and (c) material properties. It is desirable to construct a high-performance prediction model without the material properties because their measurement is laborious. The results show that using (c) as input variables did not improve the prediction accuracy as much, thus there is no need to use them.

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双螺杆喂料机中双组分混合粉的喂料系数曲线预测模型
在连续制药过程中,控制粉末流速至关重要。喂料过程的特点是每次螺杆旋转所输送的粉末量,称为喂料系数。本研究旨在开发用于预测各种配方的双组分混合粉末进料系数曲线(FFP)的模型,而之前的大多数研究都侧重于单组分粉末。研究还旨在确定合适的模型类型,并通过使用几种具有不同输入变量的给料系数预测模型,确定材料特性在提高预测精度方面的重要性。实验中产生了四个数据集,其中活性药物成分(API)的质量分数和料斗中的粉末重量范围各不相同。模型输入的候选变量包括:(a) 原料药质量分数;(b) 工艺参数;(c) 材料属性。由于材料特性的测量非常费力,因此最好在不涉及材料特性的情况下构建高性能预测模型。结果表明,将(c)作为输入变量并不能显著提高预测精度,因此没有必要使用它们。
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来源期刊
International Journal of Pharmaceutics: X
International Journal of Pharmaceutics: X Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
6.60
自引率
0.00%
发文量
32
审稿时长
24 days
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