Baxter Healthcare Corporation’s Phase I study of its pulmonary insulin administered using a small, standard dry powder inhaler demonstrated that the insulin powder can be effectively administered to the deep lung using an off-the-shelf dry powder inhaler designed for upper airway drug delivery.
The inhaled insulin, called recombinant human insulin inhalation powder (RHIIP) is made using Baxter's proprietary PROMAXX formulation technology that unlike other dry powder formulations of insulin is 95 percent insulin and does not rely on the use of inactive ingredients to facilitate delivery to the deep lung.
The study found no serious adverse events of the inhaled insulin in the subjects and demonstrated that RHIIP had a faster onset of action than SC (time to reach 10 percent of total area under the glucose infusion rate (GIR) curve 73 vs 95 min.; GIR-tmax 173 versus 218 min., p<0.0001). The duration of action (371 vs 366 min.) and total metabolic effect (GIR-AUC0-10h of 2,734 vs 2,482 mg/kg) were comparable.
According to Dr. Tim Heise, Profil Institut fur Stoffwechselforschung GmbH in Neuss, Germany, and principal investigator for the study:
"These encouraging results show the bioavailability of RHIIP compare favorably with that observed for many other inhaled insulin preparations, even though the standard type of inhaler used in this study was not optimized for delivery of insulin to the deep lung.
RHIIP may have the potential to achieve even higher bioavailability through further improvements in the insulin delivery technique, and this will be the subject of further studies."
Study results have been presented at the recent Respiratory Drug Delivery Europe 2007 Conference in Paris.
Find more details from the full report.
[Photo Credit: Medgadget]
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