Design and evaluation of a nanoparticulate system prepared by biodegradable polymers for oral administration of protein drugs.

The present work was about the preparation of nanoparticles by a complex coacervation process using the biodegradable polymers Chitosan and sodium alginate and to evaluate their suitability for oral administration of proteins. Bovine serum albumin (BSA) was used as a model protein for incorporation into the nanoparticulate system. The prepared BSA-loaded nanoparticles were characterized for size, morphology, zeta potential, BSA encapsulation efficiency and subsequent release kinetics. The physicochemical characters of the prepared nanoparticles depend mostly on polymers mass ratio, pH of the reaction medium and BSA loading concentration. The minimum average size of empty nanoparticles were found to be 339.80 +/- 02.20 nm and the BSA loaded nanoparticles prepared under varying conditions had average sizes in the range of 473.67 +/- 18.75 nm to 751.33 +/- 6.81 nm, and exhibit a high positive zeta potential. The SEM image showed spherical shaped nanoparticles. By increasing the concentration of BSA from 0.1 mg/ml to 2.8 mg/ml the loading capacity of the nanoparticulate system was increased whereas the encapsulation efficiency was decreased. The results suggest that the nanoparticulate system is a potential carrier for delivering protein drugs.