Design of a pilot plant-type pharmaceutical reactor to address the problem of interchangeability of generic semisolid formulations

Abstract

Objective and Significance

This research aims to design and develop a pilot plant-type pharmaceutical reactor with a strong focus on its volumetric capacity and heat transfer capabilities. The primary goal is to replicate design and control strategies at the laboratory or pilot scale to analyze and produce generic semisolid formulations.

Methods

Computational fluid dynamics and heat transfer modeling, utilizing the finite volume method, were employed to determine the reactor’s performance and particle trajectory during the mixing and stirring. This allowed for the establishment of optimal operational parameters and variables. Furthermore, prototypes were constructed at 1:2.5 and 1:15 scales to examine the reactor’s morphology, ensure volumetric versatility, and conduct mixing, homogenization, and coloration tests using varying volumes.

Results and Conclusions

The outcomes of this study yielded a versatile reactor suitable for processing pharmaceutical semisolids at both laboratory and pilot-scale volumes. Notably, the reactor demonstrated exceptional volumetric capacity within a single vessel while effectively facilitating heat transfer to its interior.

Graphical abstract

Keywords:

• Pharmaceutical reactor
• computational fluid dynamics
• heat transfer
• volumetric versatility

Acknowledgements

E.F. thanks the Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET) for the Ph.D. fellowship. He greatly appreciates the managers of the Unidad de Investigación en Tecnología Farmacéutica (UNITEFA) for allowing him to develop the project at their facilities and be part of their group. He also thanks his laboratory colleagues, including researchers, doctors, and fellows, for their unwavering support, collaboration, and fellowship.

Disclosure statement

The authors report no declarations of interest.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.