Optimising nanoparticles: harnessing quality by design through 3-level factorial design and box-behnken methodology

Abstract

Nanoparticles (NPs) have become essential elements in a number of scientific and industrial domains, such as materials research, drug delivery, and diagnostics, because of their special qualities and potential for focused uses. An ideal formulation procedure is essential to maximising the effectiveness and efficiency of nanoparticles. In order to optimise the formulation and production processes for nanoparticles, this research investigates the application of Quality by Design (QbD) principles in conjunction with sophisticated statistical approaches, namely the 3-level factorial design and the Box-Behnken methodology. The Quality by Design methodology is a methodical approach that prioritises predetermined goals, in-depth process comprehension, and careful control grounded in reliable science and quality risk management. When QbD is incorporated into nanoparticle optimisation, reliable and repeatable formulations that adhere to specifications with little variation are guaranteed. To look into how different factors interact and affect the properties of nanoparticles, the 3-level factorial design is used. With this design approach, a thorough understanding of the process variables can be obtained by exploring a broad variety of component values. Critical quality attributes (CQAs) include important parameters such drug encapsulation efficiency, zeta potential, polydispersity index (PDI), and particle size. These parameters are methodically examined to determine the ideal amounts of each. To further refine the 3-level factorial design, the Box-Behnken methodology is applied. Without the requirement for extensive combination testing, this response surface methodology (RSM) is especially useful for building second-order polynomial models and investigating quadratic response surfaces. By enabling a more accurate comprehension of the interactions between inputs and responses, the Box-Behnken design improves the optimisation process and makes it easier to identify the ideal circumstances for nanoparticle synthesis. By utilising both approaches in tandem, this work methodically determines ideal formulation parameters that minimise nanoparticle size and polydispersity while optimising stability and drug loading efficiency. The outcomes highlight how important a QbD framework is for directing the creation of reliable nanoparticle systems that function consistently and predictably.