Patent ID: 6635617
Filing Date: 2003-10-21
Classification: A61K

Abstract:
A method for enhancing the bioavailability of human insulin or an analogue or derivative upon pulmonary administration, said method comprising:providing an aqueous insulin formulation comprising: human insulin or an analogue or a derivative thereof, 2 to 5 Zn2+ ions per six molecules of insulin, 3 to 18 phenolic molecules per six molecules of insulin, and menthol, wherein: (i) said insulin analogue or derivative exhibits insulin bioactivity, (ii) said insulin analogue comprises (a) human insulin in which one or more amino acids have been deleted and/or replaced by other amino acids or (b) human insulin containing at least one additional amino acid, (iii) said insulin derivative comprises human insulin in which at least one organic substituent is bound to one or more of the amino acids of said insulin; (iv) said phenolic molecules are selected from the group consisting of phenol, m-cresol, chloro-cresol, thymol, 7-hydroxyindole, 2,6-dihydroxynaphthalene, 2,7-dihydroxynaphthalene, and mixtures of any of the foregoing phenolic molecules and (v) said menthol increases the bioavailability of said insulin, analogue, or derivative following pulmonary administration.