Quality by Design (Qbd) Based Development and Evaluation of Carvedilol Loaded Polymeric Nanoparticles for Enhanced Solubility

Abstract

By preparing a polymeric nanoparticle by nanoprecipitation using specific polymers like Chitosan and HPMC K15M and Poloxamer 407 as a surfactant, the drug solubility of Carvedilol, a BCS class-II drug with poor water solubility, can be improved through the release of drug over time. Critical quality parameters, such as drug release (%), entrapment efficiency (%), particle size (nm), and zeta potential (mV), are used to eliminate unnecessary process and formulation variables. The model drug has a sharp melting point, and the FT-IR and DSC investigations show that it does not interact with the polymers or show any additional peaks. Particle size, zeta potential, entrapment efficiency and in-vitro drug release were among the characteristics studied for the generated drug-loaded polymeric nanoparticles. According to the results of the drug release and stability investigations, the F6 formulation was the most reliable, boasting increased drug solubility and efficient drug trapping as it formed a nano-sized polymeric particle. Non-Fickian diffusion-controlled drug release with Higuchi kinetics was demonstrated by the correlation coefficient data and the release exponent numbers from Koresmeyer Peppa’s. Drug entrapment efficiency and in vitro dissolution rate remained constant during the 6-month stability trial, indicating that the optimised formulation (F6) is more stable.