Özet:

The present research is to formulate and evaluate the in-vivo pharmacokinetic studies on Ursodiol polymeric nanoparticle. The polymeric nanoparticles were optimized by 23 factorial design and the best formulation will be selected based on the effect of independent variable on dependent variable. The optimized polymeric nanoparticle will be subjected to in-vivo pharmacokinetic and pharmacodynamics studies. The Ursodiol polymeric nanoparticle was formulated by homogenization cum ultra-sonication method by investigating the effect of variables like polymer concentration (HPMC), homogenization time (min) and ultra sonication time (min) using a factorial design. The formulated Ursodiol polymeric nanoparticle was evaluated for particle size (nm), zeta potential (mV), polydispersity index, entrapment efficiency (%), drug content, in-vitro drug release, in-vitro release kinetic studies and stability studies as per ICH guidelines criteria. The optimized polymeric nanoparticle will be subjected to in-vivo pharmacokinetic and Pharmacodynamic studies. From the derived data U4 formulation showed predicted particle size (168.0 ± 3.24 nm), maximum zeta potential (-34.1 ± 2.34mV), less polydispersity index (0.320 ± 0.24), increased entrapment efficiency (98.62 ± 3.68%), and good release properties (92.22 ± 3.14 at 24h) among the eight formulations tested. From the in-vivo pharmacokinetic evidence, it was concluded that the polymeric nanoparticle with Ursodiol showed improved bioavailability than the marketed dosage form Ursocol SR®, by enhancing the plasma drug concentration profile like AUC and Cmax. The findings suggest that PNs have controlled drug release and can be used as a drug delivery carrier for Ursodiol to improve bioavailability

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