First trial for insulin using Microdose DPI a success
US drug delivery company MicroDose Technologies, of Monmouth Junction, New Jersey, has successfully completed a Phase I clinical study evaluating the pulmonary delivery of human insulin, with jv partner, Elan Corporation. This is the first clinical study to evaluate Elan's proprietary dry powder formulations of insulin in combination with MicroDose's novel dry powder inhaler (DPI) and initial results indicate significantly improved bioavailability compared with competitive products currently in development, the company says. This product is targeted at treating both Type I and II diabetes as a replacement for subcutaneous insulin injections.
The UK-based study was conducted in 18 healthy male volunteers to demonstrate the efficiency of delivery of Elan's dry powder insulin from the MicroDose device. Blood levels of insulin and glucose were measured over time following inhalation of either pure insulin or an insulin-trehalose formulation. Pulmonary delivery was compared with subcutaneous injected insulin as a control.
Absorption of the inhaled insulin was rapid with a time to maximum blood concentration of 37-39min compared with 102min for the subcutaneous insulin control, providing the opportunity for more rapid and complete control of blood glucose levels at meal times. The bioavailability over the initial three hours of the inhaled insulin relative to the subcutaneous dose was 23-25% depending on the formulation. These data are said to compare extremely favourably with those of competitor approaches in pulmonary drug delivery.
The MicroDose DPI is an active, multi-unit dose device, which achieves high-efficiency powder dispersion independent of patient inhalation effort and has demonstrated excellent dose reproducibility. It is designed to be lightweight and compact.
'The results of this pioneering study are very exciting and prove our ability to develop technologies which deliver active molecules to the required sites of action quickly and effectively,' commented Scott Fleming, vp marketing, MicroDose. 'The performance demonstrates clear potential to evaluate other bioactive molecules.'