Design and characterization of an oral delivery system for insulin administration

This study aimed the development and characterization of a new oral formulation with a view to obtain enteric delivery of insulin. The dosage form designed was based on the incorporation of the peptide into granules by using three formulations of insulin: a simple solution, a solution containing an association of insulin and cyclodextrin and a microemulsion containing the insulin:cyclodextrin association. Throughout the study, the following analyses were performed: the stability of the insulin with and without cyclodextrin in an accelerated stability study, the permeability of the insulin across the intestinal membrane using the everted gut-sac technique and, finally, insulin release from granules upon variation of the pH in an in vitro release experiment.