Edible Film a Possible Insulin Delivery Platform

September 22nd, 2011

In another promising development in the world of diabetes medication, the specialty pharmaceutical company MonoSol Rx is testing its unique PharmFilm as a possible oral insulin delivery platform. PharmFilm is a quick-dissolving film that can be impregnated with medication and placed under the tongue or against the inside of the cheek. The medication is quickly absorbed into the bloodstream through the mouth's mucosal membranes.

The FDA has already approved two applications of the edible film - Zuplenz to treat nausea and vomiting, and Suboxone to treat opiod dependence. MonoSol Rx is now testing two new applications for PharmFilm, one dispenses a drug to treat ADHD, and the other delivers insulin for diabetics.

Currently, insulin can only be administered through injection, as it is destroyed by acids in the digestive system. Because the postage stamp sized insulin film dissolves so quickly in the mouth, the diabetes medication bypasses the digestive tract and passes directly into the circulatory system.

MonoSol Rx and Midatech are just two of many companies racing to develop different ways to administer insulin without injections, including insulin patches, insulin inhalers, and insulin nasal sprays.

The insulin film can be manufactured in different sizes to accommodate different insulin dosages. The advantages of a dissolving insulin film for insulin dependent diabetics (especially children with diabetes and their caregivers) are obvious - no insulin injections; precise insulin dosing; a convenient, discreet and portable medication, and instant onset of action.

MonoSol Rx is collaborating with Midatech Group Ltd, a leading edge nanotechnology company which develops biocompatible nanoparticles (tiny synthetic molecules that are designed to carry and deliver drugs) to bring the oral diabetes medication to market. The insulin film has been successfully tested transbuccally (inside the cheek) in pigs and monkeys, and the partners plan to begin human trials this year.

A spokesperson for Midatech Group said, "The results of insulin PharmFilm in our primate study validate the film delivery of active insulin across the buccal mucosa for the first time. In addition, we have preclinical proof-of-concept that these results can be achieved in a controlled dose precisely tailored to suit individual needs. We anticipate results from our human clinical trials, slated to commence in the second quarter of 2011, to revolutionize treatment methods and insulin delivery for diabetics worldwide."

According to the Centers for Disease Control, nearly 24 million people in the United States are currently living with diabetes - the seventh leading cause of death in the country. Many of these diabetics (about 30%) are, or will become, insulin dependent and require insulin injections. Many are struggling with complications involving their heart, kidneys, nerves, eyes, and circulation.

Insulin is a hormone which moves blood sugar into the cells to give the body energy. Diabetics either don't produce any insulin (type 1 diabetes), can't make enough insulin, and/or can't properly make use of the little insulin they do produce (type 2 diabetes).