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Evaluation of Weight Variation in Mini-Tablets Manufactured by a Multiple-Tip Tool
Chemical & Pharmaceutical Bulletin ( IF 1.7 ) Pub Date : 2020-10-01 , DOI: 10.1248/cpb.c20-00460
Homare Kurashima 1, 2 , Shinya Uchida 1 , Yasuharu Kashiwagura 1 , Shimako Tanaka 1 , Noriyuki Namiki 1
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Recently, owing to their pharmaceutical and clinical utility, mini-tablets have been well studied by researchers. Mini-tablets are usually manufactured by compression molding using a multiple-tip tool in a rotary tableting machine. Owing to their special structure, ensuring uniformity is a very important challenge in the manufacturability of mini-tablets using the multiple-tip tool. In this study, we aimed to evaluate the weight variation in mini-tablets produced by a multiple-tip tool, which is considered to be the root cause affecting the uniformity, and to investigate the physical properties of drug granules and tableting conditions in a rotary tableting machine that could reduce this weight variation. In addition, the relationship between these factors and response was visualized using response surface analysis. It was shown that the weight variation in mini-tablets produced by a multiple-tip tool was reduced when using a forced feeder compared with an open feeder. Furthermore, in the case of an open feeder, the optimal range of the average particle size diameter of drug granules and the rotational speed of the rotating disc in the rotary tableting machine were determined from response surface analysis. It was suggested that it is possible to reduce the weight variation in the mini-tablets by selecting drug granules with an average particle size diameter of 100–150 µm and using tableting conditions with a rotational speed of 40–60 rpm. This study elucidated the factors that affect uniformity and determined their optimal range for the manufacture of mini-tablets.

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中文翻译:

用多头工具制造的迷你片剂的重量变化评估

最近,由于其在医学和临床上的实用性,研究人员对小型片剂进行了充分的研究。小型片剂通常通过在旋转式压片机中使用多尖端工具通过压缩成型来制造。由于其特殊的结构,确保均匀性是使用多尖端工具制造微型平板电脑时的一项非常重要的挑战。在这项研究中,我们旨在评估由多尖端工具生产的微型片剂的重量变化,这被认为是影响均匀性的根本原因,并研究了旋转式旋转中药物颗粒的物理性质和压片条件压片机,可以减少这种重量变化。此外,这些因素与响应之间的关系使用响应面分析进行了可视化。结果表明,与开放式喂食器相比,使用强制喂食器可减少多尖工具产生的迷你片剂的重量变化。此外,在开放式给料器的情况下,根据响应面分析确定药物压片的平均粒径的最佳范围和旋转压片机中转盘的旋转速度。建议可以通过选择平均粒径为100–150 µm的药物颗粒,并在40至60 rpm的转速下使用压片条件来减少迷你片剂的重量变化。这项研究阐明了影响均匀性的因素,并确定了其制造迷你片剂的最佳范围。

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更新日期:2020-10-28
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