Process intensification of pharmaceutical powder blending at commercial throughputs by utilizing semi-continuous mini-blending

IF 5.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY International Journal of Pharmaceutics: X Pub Date : 2024-06-26 DOI:10.1016/j.ijpx.2024.100264
Maarten Jaspers , Florian Tegel , Timo P. Roelofs , Fabian Starsich , Yunfei Li Song , Bernhard Meir , Richard Elkes , Bastiaan H.J. Dickhoff
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Abstract

Process intensification involves the miniaturization of equipment while retaining process throughput and performance. The pharmaceutical industry can benefit from this approach especially during drug product development, where the availability of active pharmaceutical ingredients (API) is often limited. It reduces the need for process scale up, as equipment used during product development and commercial production is identical. However, applications of process intensification for processing pharmaceutical powders are limited so far. Here we show that semi-continuous mini-blending can be utilized for process intensification of blending of API and excipients. Uniform blending at commercially relevant throughputs was achieved through mini-blends with a volume of less than ten liters. Our results demonstrate that blending speed, cycle time and blender fill level can be optimized without compromising blending performance. Acceptable blend uniformity is obtained over a broad range of operating parameters, by choosing the right excipients. The optimized throughput of the mini-blending process is in line with the desired throughput of a commercial Continuous Direct Compression (CDC) process.

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利用半连续性微型混合技术,在商业产量条件下强化药粉混合工艺
工艺强化包括在保持工艺吞吐量和性能的同时,实现设备的微型化。制药业可以从这种方法中获益,尤其是在药物产品开发过程中,因为药物活性成分(API)的供应往往是有限的。由于产品开发和商业生产过程中使用的设备完全相同,因此可以减少对工艺放大的需求。然而,迄今为止,工艺强化在加工药粉方面的应用还很有限。在这里,我们展示了半连续式微型混合工艺可用于原料药和辅料混合的工艺强化。通过体积小于 10 升的微型混合器,实现了具有商业相关吞吐量的均匀混合。我们的研究结果表明,可以在不影响混合性能的情况下优化混合速度、周期时间和混合器填充水平。通过选择合适的辅料,可在广泛的操作参数范围内获得可接受的混合均匀度。小型混合工艺的优化产量与商用连续直接压缩(CDC)工艺的理想产量一致。
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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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