Advancing Nanoparticle Production: Scaling Up Techniques, Challenges, and Future Perspectives in Pharmaceutical Applications

Abdelmonem, Rehab; Ayman, MennaAllah; Lofty, Sara Emad; Ezzat, Yara; Nabeah, Jaklin Momtaz; Mohamed, Hager; Safwat, Mohamed; Abdelzaher, Abdelrahman; AboAlfa, Alaa; Abdelkhalek, Mohamed; Ali, Roaa Mohamed; Samy, Salma; Fathy, Mai Hany; Abdelati, Aliaa; Abdellatif, Menna; Eltahan, Mahmoud

doi:10.21608/jpsdm.2025.374728.1031

Advancing Nanoparticle Production: Scaling Up Techniques, Challenges, and Future Perspectives in Pharmaceutical Applications

Document Type : Review Articles.

Authors

¹ Department of Industrial Pharmacy, College of Pharmaceutical Sciences and Drug Manufacturing, Misr University for Science and Technology (MUST), P.O. Box 77, Giza, Egypt.

² College of Pharmaceutical Sciences and Drug Manufacturing, Misr University for Sciences and Technology, 6th October City, Egypt.

10.21608/jpsdm.2025.374728.1031

Abstract

Abstract
Background: Nanoparticles (NPs) have transformed pharmaceutical sciences by enhancing drug delivery, solubility, and absorption. However, scaling up NP production from laboratory settings to industrial capacities is facing immense challenges due to process difficulties, consistency issues, and high costs.
Objectives: This review discusses recent progress, challenges, and critical process parameters (CPPs) in scaling up different NP preparation methods. It highlights sustainable strategies, process limitations, and future opportunities in pharmaceutical nanoparticle production.
Methods: A systematic review was conducted using international databases such as (Scopus, PubMed, Web of Science, Google Scholar) between 2012 and 2024. The keywords used in the primary search included scale-up, challenges, limitations, critical process parameters, and nanoparticles. This study considered conventional and novel methods for preparing nanoparticles, including thin film hydration, ethanol injection, ultrasonication, spray drying, and high-pressure homogenization.
Results: This review outlines and discusses critical process parameters such as mixing speed, temperature control, choice of solvent, and flow rate that impact NP size, morphology, and stability during scale-up. Advanced techniques such as microfluidics and ethanol injection allow one to control the characteristics of nanoparticles with precision, while high-pressure homogenization ensures particle-size consistency. More importantly, environmentally friendly synthesis approaches are a useful route toward sustainable production practices.
Conclusions: Scaling up NP production requires optimization of process parameters, equipment design, and a focus on reproducibility and cost-efficiency. While challenges persist, adopting green synthesis methods and developing regulatory frameworks will enhance clinical translation and commercial viability of NP-based drug delivery systems.

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