Dandamudi, Madhuri (2014) Development of a nanoparticulate system for oral delivery of insulin. (MSc(R) thesis), Kingston University, .

Abstract

Around the world 346 million people are suffering from diabetes and the number is increasing drastically. Subcutaneous administration of Insulin is most common therapy for diabetes however, needle phobia and pain results in poor patient compliance. Developing an oral formulation for insulin is a challenge primarily because of its gastric instability and poor permeation across intestinal membrane. Previous reports have shown particulate delivery systems being effective in delivering insulin via oral route. The aim of the present study is to prepare and evaluate the potential of polymer based nanopartieles for oral delivery of insulin. Nanopartieles were prepared using chitosan polymer and sodium tri polyphosphate (TPP) as cross linking agent via ionic gelation method. Characterization studies including morphology (scanning electron microscopy), particle size, zeta potential and loading efficiency have been evaluated. Insulin release profile from nanopartieles is performed in simulated gastric fluid and simulated intestinal fluid using dialysis membrane. Permeation studies were conducted using ussing's camber on Caco-2 cell monolayers which mirnick intestinal membrane. Morphological analysis revealed that the insulin loaded nanopartieles were spherical structured with partial aggregation. Size of nanopartieles ranged between 203 ± 2.40 nm to 302 ± 9.38 nm with varying zeta potential of 26.16 ± 3.00 mV to 31.80 ± 2.47 mV. Loading efficiency of insulin was found to be 84.70 ± 1.20%, which is assayed at 214 run using UV spectrophotometer. Insulin release studies had shown a sustained profile with maximum release of 43.97 ± 0.20% after 24 hour period. Insulin transport across caco-2 monolayers has been confirmed through the permeation studies using ussing's chamber. Decrease in resistance of cells (indicating permeation) is observed when formulation is placed on the apical side of the caco-2 monolayer. With further studies ongoing, the current data suggests that chitosan-based nanoparticles enable successful insulin loading with effective permeation ability through the epithelial membrane, demonstrating the potential of these systems in delivering insulin via oral route

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