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 treating osteoporosis or osteopenia in a human comprising administering to the human 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 selected from the group of intranasal, buccal, gastrointestinal, vaginal and transdermal.
3 . The method of claim 1 , wherein the administration causes a PTH serum level having a Tmax less than 40 minutes.
4 . The method of claim 1 , wherein the administration causes a PTH serum level above background for less than four hours.
5 . The method of claim 1 , wherein the administration is intranasal.
6 . The method of claim 1 , wherein the composition is an aerosol comprising about 0.3 to 30 μg of PTH per kg weight of the patient.
7 . The method of claim 1 , wherein the composition is an aerosol comprising 0.5 to 1.0 mg of PTH per 0.1 ml of solution.
8 . The method of claim 1 , wherein the administration is intranasal given at a dosage frequency of between 0.1 to 24 hours.
9 . The method of claim 1 , wherein the administration is intranasal comprising the steps of:
a) filling a nasal spray pump unit with the composition;
b) priming the spray pump unit;
c) removing spray droplets present outside the spray pump unit;
d) tilting until the spray pump unit is in a straight line with a nasal passage; and
e) spraying the solution into the nasal passage.