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New Insulin Delivery Method on its Way

Posted Dec 04 2009 12:00am

From Geriatric Pharmacy Intern Yariagna Rollan Pharm.D.(c)
University of Florida College of Pharmacy

The biggest drawback of insulin treatment is the way in which it needs to be administered. Many patients are afraid to start treatment or find it difficult to manage, especially in the elderly population; they need to be physically and mentally capable. Nicola Napoli, MD, PhD and colleagues from the Division of Endocrinology and Metabolism of the University Campus Bio-Medico di Roma in Italy, are experimenting with new routes for administering insulin in order to solve the most important problem in diabetic patients, the injections.

They are currently testing the safety and efficacy of the buccal spray insulin called Oral-Lyn, which was developed by Generex Biotechnology Corporation. Oral-Lyn offers a pain-free option to prandial insulin injections. The spray contains regular acting human DNA insulin dissolved in a buffer at a neutral pH, identical to the injection form. There are also absorption enhancers, stabilizers, and a non-CFC propellant completing the product. This buccal spray looks like an asthma inhaler and delivers insulin to the oropharyngeal mucosa, the inner lining of the mouth, with a peak of 10 minutes post administration, and complete absorption.
The spray was tested on thirty-one patients with diagnosed impaired glucose tolerance to manage their blood sugar levels. A standard 75gm oral glucose tolerance test was performed and the spray was given in, 4, 6, or 12 insulin puffs. There was no difference found in the 4 or 6 puffs group compared to placebo but on the 12 puff group there was a decrease in blood sugar level of around 29.6% compare to no treatment at all. They also noted an increase in insulin levels and no hypoglycemia was reported during the study. Other short-term trials have also been successful, but they included patients with type 1 and type 2 diabetes.

The downfall, small and short-term studies don’t warrant its use. These results need to be replicated on long-term trials in order for its endorsement on the U.S, which are already in process. The good news is that Generex has received approval for the commercial sale of Oral-Lyn in several countries already. This new method gives hope to both type 1 and type 2 diabetics for a not too far in the future non-injectable, pain free option to deliver insulin.
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