Determination of Mixing Efficiency in Various Laboratory-Scale Semi-Solid Formulation Techniques Through Computational Fluid Dynamics and Finite Volume Simulations

IF 2.7 4区 医学 Q2 PHARMACOLOGY & PHARMACY Journal of Pharmaceutical Innovation Pub Date : 2025-04-05 DOI:10.1007/s12247-025-09963-w
Emiliano Frenquelli, Juan P. Real, Juan M. Llabot, Liliana Pierella, Santiago D. Palma, Daniel A. Real
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Abstract

Objective

This study evaluated various mixing, homogenization, and dosing techniques for laboratory-scale semi-solid formulations, focusing on parameters such as volume, rpm, container morphology, and paddle design to determine efficiency and efficacy.

Methods

Three three-dimensional vessels were analyzed: mortar and pestle, blender, and a custom-designed conical reactor. Simulations using computational fluid dynamics (CFD) and the finite volume method were conducted to study particle trajectories and the homogenization process during the mixing, agitation, and emptying phases. Additionally, experimental validation was performed in parallel with the simulations, using similar operational conditions for each system.

Results

The CFD simulations revealed that the conical reactor was the most efficient under all conditions (high and low volumes and revolutions). Further evaluations showed that the helical (screw) paddle inside the reactor provided the highest efficiency in mixing and significantly accelerated the complete emptying of the reactor. Experimental validation corroborated the simulation results, showing a high degree of agreement between both methods and demonstrating the reliability of CFD simulations under real operational conditions.

Conclusions

The results demonstrate the relevance of the conical reactor and its helical screw paddle for improving the efficiency of mixing and dosing in semi-solid formulations, offering valuable insights for pharmacists involved in therapy customization. The findings emphasize the need for further research to refine these systems and enhance their efficiency in pharmaceutical applications.

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通过计算流体力学和有限体积模拟确定各种实验室规模半固体配方技术的混合效率
本研究评估了实验室规模半固体制剂的各种混合、均质和加药技术,重点研究了体积、转速、容器形态和桨叶设计等参数,以确定效率和疗效。方法对三种三维容器进行分析:臼杵、搅拌器和定制的锥形反应器。采用计算流体力学(CFD)和有限体积法进行了模拟,研究了混合、搅拌和排空阶段的颗粒轨迹和均匀化过程。此外,实验验证与模拟并行进行,每个系统使用相似的操作条件。结果CFD模拟结果表明,锥形反应器在各种工况下(高、低容积和转数)效率最高。进一步的评估表明,反应器内的螺旋桨提供了最高的混合效率,并显著加速了反应器的完全排空。实验验证验证了仿真结果,显示了两种方法之间的高度一致性,证明了CFD模拟在实际工况下的可靠性。结论锥形反应器及其螺旋桨对提高半固体制剂的混合和给药效率具有重要意义,可为临床药师进行药物定制提供参考。研究结果强调需要进一步研究以完善这些系统并提高其在制药应用中的效率。
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来源期刊
Journal of Pharmaceutical Innovation
Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-
CiteScore
3.70
自引率
3.80%
发文量
90
审稿时长
>12 weeks
期刊介绍: The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.
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