Preparation and Evaluation of Poly(lactic acid)/Poly(vinyl alcohol) Nanoparticles Using the Quality by Design Approach

Abstract

The aim of the study was to prepare and evaluate the potential use of poly(lactic acid)/poly(vinyl alcohol) (PLA/PVA) nanoparticle formulations as a drug delivery system. The nanoparticle formulations were successfully developed by the double emulsification/solvent evaporation method. The developed formulations were optimized using the quality by design approach of the ICH Q8 (Pharmaceutical Development) guideline. In the studies, the effects of emulsifying devices, evaporation technique, centrifugation effect, and polymer concentrations on the physicochemical parameters of the formulations were investigated to obtain the best results. Furthermore, the prepared formulations were evaluated for clarity, particle size, distribution, zeta potential, surface and morphological features, preparation efficiency, and long-term stability. Based on the obtained results, the nanoparticle formulation containing 12.5% PLA, 1% primer, and seconder PVA has a suitable particle size (181.7 ± 2.194 nm) and distribution (0.104 ± 0.049), zeta potential (-0.88 ± 0.45 mV), and high preparation efficiency (65.38%), and nanoparticles were spherical, had a smooth surface, and were stable up to 12 months. In conclusion, this novel formulation can be used as a potential drug delivery system.