Inhaled Insulin Shows Promise in Trial

The results of a phase I clinical trial of inhaled insulin have demonstrated efficient delivery and rapid absorption of insulin. This was the first study to evaluate the dry powder insulin formulation of Elan Corp. plc (Dublin, Ireland) in combination with the dry powder inhaler (DPI) of MicroDose (Monmouth Junction, NJ, USA).

The product is designed for treating both type I and type II diabetes patients in a convenient approach to replacing the subcutaneous insulin injections required to control meal-related glucose levels. Absorption of the inhaled insulin was rapid, with a Tmax (time to maximum blood concentration) of 37-39 minutes, compared with a Tmax of 102 minutes for subcutaneous delivery. The bioavailability over the initial three hours of the inhaled insulin relative to the subcutaneous dose was 23-25%, depending on the formulation. The multi-unit DPI achieves high-efficiency power dispersion independent of patient inhalation effort and has demonstrated excellent dose reproducibility, says MicroDose.

"The performance levels we have observed demonstrate a clear potential to work with other bioactive molecules,” said Scott Fleming, vice president, marketing, MicroDose.




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