[Pharmacokinetic comparison between regular insulin and oral insulin based on superporous hydrogel polymers in healthy volunteers]

All contemporary methods of insulin administration are non-physiological. Insulin is not absorbed from the gastrointestinal tract because of its peptide nature. The aim of the present study was to examine the absorption of oral insulin from gastrointestinal tract, using novel oral formulation- adding a delivery agent superporouse hydrogel [SPH] and SPH composite [SPHC] in combination with insulin. Capsules containing insulin and SPH and SPHC were administered orally, to 15 non-diabetic subjects in order to assess its biological effects and safety. Plasma glucose, insulin and c - peptide serum levels were determined, at timed intervals up to 4 h. In the present study, we showed that AUC of exogenous insulin in polymer -insulin group was higher than sub-cutaneous regular insulin group. It means that addition of SPHC polymer caused increase in insulin absorbtion.In addition, Insulin Tmax in polymer group was longer than sub-cotaneaus insulin group. Blood glucose AUC in sub-cotaneaus group was higher than polymer group.AUC C-peptide serum level in polymer group was higher than sub-cutaneous group. Insulin in combination with a novel delivery agent, SPH and SPHC, given orally is absorbed through the GI tract in a biologically active form. This was demonstrated by suppression of endogenous insulin secretion

effect of oral insulin based on SPH and SP on serum levels of glucose, insulin and C-peptide in healthy volunteers

All contemporary methods of insulin administration are non-physiological. The euglycemia that is achieved in at the expense of the adverse effects of systemic hyper-insulinemia, emphasize the importance of devising methods to deliver insulin physiologically and directly into the portal circulation. The aim of the present study was to evaluate the oral absorption of insulin from gastrointestinal tract, using novel oral drug delivery system delivery based on superporouse hydrogel [SPH] and SPH composite [SPHC] in combination with insulin. This study has been done based on interventional clinical trial in healthy volunteers. Capsules containing insulin and SPH and SPHC in various combination were administered orally, to 15 non-diabetics subjects in order to assess this biological effects and safety. Serum glucose, insulin and C - peptide levels were determined, at predetermined timed intervals up to 4 h. An increase in serum insulin level was demonstrated in all subjects that used polymer plus insulin. The nadir of serum glucose level appeared after 60-120 min following the ingestion of polymer plus insulin. Serum C - peptide levels were suppressed while exogenous insulin was absorbed at the same time. No adverse effects were detected during the trial and several weeks following the trial using SPH based drug delivery system. Insulin in combination with novel delivery agents, SPH and SPHC, given orally was partially absorbed through the GI tract in a biologically active form. This was demonstrated by serum glucose lowering effect of the delivery system as well as a suppression of plasma C-peptide which also represented a decrease in endogenous insulin secretion