Formulation and optimization of albumin nanoparticles loaded ivabradine hydrochloride using response surface design

Abstract

A modified controlled release system for cardio protective drug was developed by preparing Bovine serum albumin nanoparticles (BSA NPs) by desolvation method using Response surface methodology (RSM). Ivabradine HCl (IBH) was used as a model drug and the NPs were prepared to reduce the dose and frequency of administration. Five batches of NPs containing IBH with increasing concentration of polymer were prepared and characterized for % yield, % drug loading, particle size, zeta potential and surface morphology. The formulation for optimization was selected based on the results of process yield and drug loading. Data obtained from the best formulation was used to select the constraints for independent variables, A (Stirring speed) and B (Stirring time) to generate experimental runs. The NPs were characterized for particle size, poly dispersibility index, drug loading, zeta potential, % yield, Fourier transform infra-red spectroscopy (FTIR), drug loading efficiency, in vitro release studies, in vitro release kinetics, differential scanning calorimetry (DSC) and surface morphology was analyzed by scanning electron microscopy (SEM). The optimum concentration of BSA increased the % yield and % drug loading efficiency. The NPs had mean particle size distribution of 137.2–501.8 nm. The particles were in nano size and the zeta potential studies suggested that the NPs possessed negative surface charge indicating high degree of stability. The controlled release of drug suggested Korsmeyers- Peppas model as the possible release mechanism. IBH NPs could be a promising contender for treatment of heart failure.