Abstract

We are introducing design, development and preliminary feasibility study of nanocomposites (made of Food and drug administration approved layered montmorillonite (Mt) and biodegradable polymer Poly lactic-co-glycolic acid (PLGA)), as a vehicle for oral administration of insulin. A systematic study on the variation of Mt-PLGA ratio was focused to reduce particles to the submicron size range while maintaining insulin's bioactivity. The synthesized Insulin-Mt-PLGA nanocomposites were successfully characterized with various techniques and compared with the Insulin-PLGA nanoparticles for their drug content, physico-chemical properties, in-vitro insulin release profile and cytotoxicity. High encapsulation efficiency, desirable particle size, prolonged gastric residence time, extended release of insulin in simulated gastrointestinal fluid and biocompatibility indicated the effectiveness of presence of Mt in the synthesized Mt-PLGA nanocomposites for the oral delivery of insulin. Thus, on the basis of our preliminary research findings, it could be concluded that the developed biocompatible Insulin-Mt-PLGA nanocomposites with double functionality of low pH stability and mucoadhesivity may offers promise to overcome the difficulties associated with the oral drug delivery of insulin.

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