Development and Evaluation of Insulin Incorporated Nanoparticles for Oral Administration

The current study was designed to prepare and characterize insulin incorporated nanoparticles by complex coacervation process followed by antidiabetic study of orally administered insulin incorporated nanoparticles in diabetic rats. The nanoparticles were characterized for particle size, loading and entrapment efficiency as well as in vitro release of incorporated insulin. The prepared nanoparticles were found to have an average particle size of 551.67？nm . The highest entrapment efficiency and loading capacity values were found to be of and , respectively. Oral administration of 10？IU/Kg of insulin loaded nanoparticles to diabetic rats showed a maximum blood glucose change of at 5-hours time period. The results obtained indicate the potential of prepared nanoparticulate system as a carrier for oral delivery of insulin. 1. Introduction Oral route is considered to be more convenient, safe, and most the acceptable route of administration of drugs for chronic therapy. In the treatment of insulin dependent diabetes mellitus or type-1 diabetes, insulin is generally administered parenterally via subcutaneous route. But this clinical therapy suffers from many disadvantages, for example, local discomfort, inconvenience of multiple administration, and occasional hyperinsulinemia due to overdose [1]. However insulin administered by oral route is not as effective as by subcutaneous route because of poor absorption in gastrointestinal tract because of it’s large size and hydrophilic nature. Insulin due to proteinaceous in nature is degraded by gastric acid or proteolytic enzymes present in GI tract that act as the most important barrier limiting the absorption of insulin [2]. Therefore numbers of research are carried out to administer and make insulin available orally for treatment of Diabetes. Entrapment of insulin within the nanoparticulate carrier system is a very good approach to increase the bioavailability of insulin after oral administration. The nanoparticulate carrier system is protecting insulin from the digestive enzymes in GI-tract. In the present research the nanoparticles are prepared by using two hydrophilic biodegradable polymers chitosan and alginate. Chitosan is a natural cationic polysaccharide derived from deacetylation of chitin, which is, after cellulose, the most abundant polymer found in nature. It is hydrophilic, biocompatible, and biodegradable in nature [3]. Because of its bioadhesive property, chitosan has also received substantial attention in novel bioadhesive drug delivery systems with the aim to improve the bioavailability of drugs