PTH FORMULATIONS AND METHODS OF USE

摘要

What is described is an aqueous pharmaceutical formulation of PTH, comprising PTH(I -34) and a nonionic surface active agent, a dosage form comprising the formulation, a system of delivering PTH to a human, comprising exposing a layer of mucosal cells to the formulation, and a method of using such formulation for treating osteoporosis in a mammal, preferably wherein a time to maximum plasma concentration, Tmax, of PTH(I -34) following administration is less than 30 minutes. Also described is a method for treating osteoporosis in a mammal comprising administering intranasally a PTH formulation comprises a therapeutically effective amount of PTH(I -34) and one or more excipients selected from the group consisting of a solubilizing agent, a chelating agent, and one or more polyols. Comprising PTH(l-34) and a nonionic surface active agent. Also described is a use of PTH(l-34) in the manufacture of a medicament for treating osteoporosis in a mammal, wherein the medicament comprises a therapeutically effective amount of PTH(I -34) and one or more excipients selected from the group consisting of a nonionic surface active agent, a solubilizing agent, a chelating agent, and one or more polyols.