ROBERT MICHAEL STOTE
Medical Practice in Saint Petersburg, FL

2009032, Dec 31, 2009

Jun 5, 2009

12/479348

Robert Stote - Gulfport FL, US
Poul Strange - Princeton Junction NJ, US

CPEX Pharmaceuticals, Inc. - Exeter NH

A61K 49/00, A61K 38/28, A61P 3/10

424 92, 514 3

The present invention provides a method for achieving a therapeutically effective plasma levels of insulin by administering at least two doses of pharmaceutical formulation of insulin sequentially into the same nostril. The administration of the second dose in the same nostril gives substantially higher plasma levels of insulin when compared with sequential administration in two different nostrils. Without being limited to any specific physiological mechanism, it is believed that the first dose of insulin acts as a loading dose. This loading dose is required to achieve the subsequent plasma levels of insulin that are observed with subsequent doses. The Cmax of plasma insulin achieved by the methods and formulations of the present invention is at least about 70 microU/ml when plasma insulin is measured from about 0 to about 45 minutes after administration of a second dose. The AUC achieved is at least about 1800 microU/(ml*min). When administered sequentially in the same nostril, the Cmax of plasma insulin after a second dose is about five-fold greater than the Cmax of plasma insulin observed after the first dose; note, plasma insulin is measured from about 0 to about 45 minutes after administration of a second dose.