Journal of Nanomedicine & Nanotechnology

Abstract

Optimization of Galantamine Loaded Bovine Serum Albumin Nanoparticles by Quality by Design and Its Preliminary Characterizations

Aditi Poddar and Krutika K Sawant

Alzheimer’s disease is a progressive neurodegenerative disorder having a severe socio-economical and medical burden all over the world. The objective of this work was to develop nanoparticulate drug delivery system for Galantamine Hydrobromide (GAL) with the aid of Quality by Design (QbD) for intranasal administration to improve its targeting to brain. Bovine Serum Albumin (BSA) nanoparticles were prepared by desolvation process. Quality Target Profile and Critical Quality Attribute was set, proper risk identification and risk analysis was conducted using the Failure Mode and Effect Analysis. After proper risk assessment, optimization of the formulation was done using the Box-Behnken Design. Differential scanning calorimetry (DSC) and X-ray diffraction (XRD) were conducted. The characterization was done by studying the entrapment efficiency, particle size, zeta potential, transmission electron microscopy and atomic force microscopy. Drug amount, pH of aqueous phase, addition rate of desolvating agent was identified as parameters for Box-Behnken Design. The DSC of GAL nanoparticles did not show any peak at the melting point of GAL, proving its entrapment. Entrapment efficiency upto 78% could be achieved. A negative zeta potential was observed for GAL nanoparticles, ranging from -13 mV ± 0.25 to -11 mV ± 0.32. Nanoparticles were spherical, uniform in size with less than 200 nm. The surface was smooth with few undulations, may be due to GAL particles adsorbed on the surface during ionic interaction between GAL and BSA. Therefore, GAL nanoparticles were formulated employing a very simple, cost effective desolvation method.