Stability-Focused Nanoparticle Development: Applying Particle Size Stability as a Response Factor in the Design of...

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Chemical Engineering

Background:

• Particle size stability is crucial for nanoparticle delivery systems but typically assessed late in development.
• Current methods often overlook particle size stability during the initial design phases of experiments (DoE).

Purpose of the Study:

• To evaluate the integration of particle size stability as a response factor within a DoE framework.
• To enable early insights into formulation stability during the development of nanoparticle delivery systems.

Main Methods:

• Utilized nanostructured lipid carriers loaded with copaiba oil as the model formulation.
• Implemented a DoE with 14 runs and a central point in sextuplicate.
• Analyzed data using multiple linear regression analysis.

Main Results:

• Developed a predictive model for formulation stability in days using predetermined parameters (size variation, Polydispersity Index [PdI], and analysis quality).
• The model identified statistically significant predictors for stability.
• Successfully optimized the nanoparticle formulation based on particle size stability.

Conclusions:

• Demonstrated the practical application of DoE for optimizing nanoparticle formulations by incorporating particle size stability as a response factor.
• This methodology facilitates early-stage knowledge acquisition regarding formulation stability.
• Highlights a novel approach to enhance the efficiency of nanoparticle formulation development.