COMPOSITIONS AND METHODS FOR ENHANCED MUCOSAL DELIVERY OF PARATHYROID HORMONE
Pharmaceutical compositions and methods are described comprising at least a parathyroid hormone peptide (PTH) preferably PTH 1-34 and one or more mucosal delivery-enhancing agents for enhanced nasal mucosal delivery of PTH, for treating or preventing osteoporosis or osteopenia in a mammalian subject, preferably a human.
1 . A method of administering a PTH to a human comprising contacting a layer of mucosal cells in the human with a composition comprising an aqueous mixture of PTH, a cyclodextran, and didecanoylphosphatidylcholine at concentrations sufficient to enhance permeation across the cellular layer, the composition consisting of droplets wherein less than 10% of the droplets are less than 10 microns in diameter.
2 . The method of claim 1 , wherein the administration is non-parenteral.
3 . The method of claim 1 , wherein the administration is selected from the group of intranasal, buccal, gastrointestinal, vaginal and transdermal.
4 . The method of claim 1 , wherein the administration is intranasal.
5 . The method of claim 1 , wherein the composition is an aerosol comprising droplets of from 1 to 700 microns in size.
6 . The method of claim 1 , wherein the composition is an aerosol comprising about 0.7 to 25 μg of PTH per kg weight of the human.
7 . The method of claim 1 , wherein the composition is an aerosol comprising 50 to 800 μg PTH.
8 . The method of claim 1 , wherein the administration is gastrointestinal.
9 . The method of claim 1 , wherein the administration is gastrointestinal having a controlled release delivery wherein Tmax is less than 40 minutes from the time of release.