Oral Insulin Spray May Offer Preprandial Advantages

Simplicity of an oral insulin spray “will facilitate acceptance and increase use by primary care physicians and patients alike. Learn more about Oralyn by reading our new product review at

https://www.diabetesincontrol.com/modules.php?name=News&file=article&sid=2757

A pharmacokinetic study in healthy volunteers shows that an investigational oral insulin spray formulation "is mainly absorbed and effective in the first 2 hours after its administration, which is the crucial time period for postprandial glucose control." The possibility of using "preprandial insulin just a few minutes before meals represents a substantial improvement in quality of life," the investigators say.

Dr. Gerald Bernstein from Generex Biotechnology, Toronto, Canada, stated that, “with the ORA-LYN insulin spray, "human regular insulin (used for many years) is delivered with an asthma like device (common and familiar to patients and doctors) to the buccal mucosa (a venerable absorption site) by a metered spray."

Dr. Simona Cernea and colleagues from Hadassah Hebrew University Hospital, Jerusalem, Israel evaluated the pharmacokinetics and pharmacodynamics of the product in comparison with subcutaneous regular insulin using a euglycemic clamp in seven healthy volunteers.

Except for the highest dose of oral insulin spray (20 puffs), maximum insulin concentrations were significantly lower for the spray than for subcutaneous insulin, the authors report in the June Diabetes Care, but there was a clear dose-response in serum insulin concentrations with the spray.

Total insulin delivered (as measured by AUC) was substantially lower with the insulin spray than with subcutaneous insulin, the report indicates. The time to maximum insulin concentration, however, was significantly shorter for oral insulin spray than for subcutaneously injected insulin, the researchers note.

Glucose consumption increased more rapidly after oral insulin administration than after subcutaneous injection of insulin, the results indicate, and there was a dose-dependent increase in the maximum metabolic effect and the amount of glucose infused after oral insulin spray.

Dr. Berstein hopes the simplicity of an oral insulin spray "will facilitate acceptance and increase use by primary care physicians and patients alike. Patients with type 1 (diabetes) will be willing to administer insulin more often and patients with type 2 (diabetes) will be willing to utilize insulin earlier in treatment rather than as a last resort."

He added, "The product has been licensed in Ecuador and we hope to have it available for consumption some time this summer… Following a successful launch we will seek to market ORA-LYN in additional South American countries."

Diabetes Care 2005;28:1353-1357.