Pth formulations and methods of use

Details Pth formulations and methods of use Pth formulations and methods of use

A - Human Necessities

61

K

A61K 38/29 (2006.01) A61K 47/18 (2006.01) A61K 47/24 (2006.01) A61K 47/26 (2006.01) A61K 47/40 (2006.01)

Patent

CA 2625084

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.

Formulation pharmaceutique aqueuse de PTH, qui renferme la substance PTH(I -34) et un tensioactif non ionique, forme pharmaceutique contenant la formulation, système de délivrance de PTH à l'homme par exposition de couche de cellules mucosales à la formulation, et procédé d'utilisation de la formulation pour le traitement de l'ostéoporose chez un mammifère, de préférence avec un temps de concentration de plasma maximum, Tmax, de PTH(I-34) après l'administration inférieur à 30 minutes. On décrit aussi un procédé de traitement de l'ostéoporose chez un mammifère par administration intranasale de formulation PTH comprenant une quantité thérapeutiquement efficace de PTH(I-34) et un ou plusieurs excipients pouvant être agent de solubilisation, agent de chélation et un ou plusieurs polyols, PTH(I-34) et un tensioactif non ionique. On décrit encore une utilisation de PTH(l-34) pour l'élaboration de médicament utilisable dans le traitement de l'ostéoporose chez un mammifère, comprenant une quantité thérapeutiquement efficace de PTH(I-34) et un ou plusieurs excipients pouvant être tensioactif non ionique, agent de solubilisation, agent de chélation et un ou plusieurs polyols.

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