Insulin is a peptide hormone produced by beta cells of the pancreatic islets; it is considered to be the main anabolic hormone of the body. It regulates the metabolism of carbohydrates, fats and protein by promoting the absorption of carbohydrates, especially glucose from the blood into liver, fat and skeletal muscle cells. When Human body is unable to produce insulin a condition is developed which is known as type 1 diabetes mellitus which is characterized by abnormally high blood glucose concentrations and generalized body wasting In type 2 diabetes mellitus the destruction of beta cells is less pronounced than in type 1 diabetes, and is not due to an autoimmune process. Instead there is an accumulation of amyloid in the pancreatic islets, which likely disrupts their anatomy and physiology.

Human insulin could be produced in large quantities by recombinant DNA technologies. A number of attempts have been made in the past to overcome the problems associated with the oral delivery of insulin, but with little success.

Based on the  published results, insulin PLGA NP composed from human insulin (5 mg) encapsulated in PLGA 2.5% (w/v) mixed with PEG (2 kDa, 5% w/w) and the external aqueous phase contained 1.25% of PVA (%w/v) were prepared by the modified double emulsion solvent evaporation technique. The resulting NP have been investigated for oral administration of recombinant human insulin (100 IU/kg) in diabetic rats. Our animal model, Male Sprague–Dawley rats (12-week-old, obtained from National researches center, Cairo, Egypt.) weighing 250-300 gm were fasted for 6 hours prior to the induction of type I diabetes via i.p injection of streptozotocin (50-60 mg.kg-1, pH=4.5). Rats with blood glucose levels >250 mg dl-1 were considered to be in a diabetic state. Three percent sodium bicarbonate solution (500 μL) in phosphate buffer saline (PBS) was administered through an oral gavage to neutralize gastric acid, a protease inhibitor -PI-(NEthylmaleimide, 2 mM) was physically mixed with free insulin or insulin PLGA-NP before oral administration. To investigate the effect of PI, other two animal groups of rats were utilized for free insulin and insulin PLGA-NP without PI.

Article Link: https://www.scitechnol.com/peer-review/recombinant-human-insulin-plga-np-administered-orally-after-combination-with-a-protease-inhibitor-nethylmaleimide-in-vivo-results-PNeg.php?article_id=8260

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