Method of delivering parathyroid hormone to a human
What is described is a method of delivering PTH to a human, comprising exposing a layer of mucosal cells to a mixture of PTH and an enhancer, wherein the enhancer is capable of modulating the barrier function of a cellular tight junction. Specifically, the method of delivering PTH to a human by intranasal administration comprises use of an aqueous solution of growth and excipients in a bottle and a droplet-generating actuator attached to the bottle and fluidly connected to the PTH solution in the container, wherein the actuator produces a spray of the PTH solution through a tip of the actuator when the actuator is engaged, wherein the spray of PTH solution has a spray pattern ellipticity ratio of from about 1.0 to about 1.4 when measured at a height of 3.0 cm from the actuator tip.
1 . A method of delivering PTH to a human, comprising exposing a layer of mucosal cells to a mixture of PTH and an enhancer, wherein said enhancer is capable of modulating the barrier function of a cellular tight junction.
2 . The method of delivering PTH of claim 1 , wherein said method utilizes a non-parenteral administration.
3 . The method of delivering PTH of claim 2 , wherein said method of administration is selected from the group consisting of intranasal, buccal, gastrointestinal, vaginal and transdermal.
4 . The method of delivering PTH of claim 3 , wherein said method is an intranasal administration.
5 . The method of delivering PTH of claim 4 , wherein said intranasal administration comprises delivering an aerosol comprising droplets of between about 1 and about 700 microns in size.
6 . The method of delivering PTH of claim 4 , wherein said intranasal administration comprises delivering an aerosol comprising about about 0.7 to about about 25 μg PTH per kg weight of the patient.
7 . The method of delivering PTH of claim 4 , wherein said intranasal administration comprises delivering an aerosol comprising about 50 to about 800 μg PTH.
8 . The method of delivering PTH of claim 2 , wherein said method is an oral delivery.
9 . The method of delivering PTH of claim 8 , wherein said oral delivery is a controlled release delivery wherein Tmax is less than about 40 minutes from the time of release.
10 . A method of delivering PTH to a human by intranasal administration comprising use of an aqueous solution of growth and excipients in a bottle, and a droplet-generating actuator attached to said bottle and fluidly connected to the PTH solution in the container, wherein said actuator produces a spray of the PTH solution through a tip of the actuator when said actuator is engaged, wherein said spray of PTH solution has a spray pattern ellipticity ratio of from about 1.0 to about 1.4 when measured at a height of 3.0 cm from the actuator tip.
11 . The method of claims 10 , wherein the PTH spray is comprised of droplets of the PTH solution wherein less than about 5% of the droplets are less than 10 μm in size.
12 . The method of claims 10 , wherein the PTH spray is comprised of droplets of the PTH solution wherein less than about 1% of the droplets are less than 10 μm in size.
13 . The method of claims 10 , wherein the PTH spray has a spray pattern major axis and minor axis of about 25 and about 40 mm, respectively.
14 . The method of claims 10 , wherein the PTH spray is comprised of droplets of the PTH solution, wherein less than about 90% of the droplets are about 250 μm or less in size.
15 . The method of claims 10 , wherein the PTH spray is comprised of droplets of the PTH solution, wherein less than about 90% of the droplets are about 120 μm or less in size.
16 . The method of claims 10 , wherein the PTH spray is comprised of droplets of the PTH solution wherein less than about 50% of the droplets are about 75 μm or less in size.
17 . The method of claims 10 , wherein the PTH spray is comprised of droplets of the PTH solution wherein less than about 50% of the droplets are about 50 μm or less in size.
18 . The method of claims 10 , wherein the PTH spray is comprised of droplets of the PTH solution, wherein less than about 10% of the droplets are about 30 μm or less in size.
19 . The method of claims 10 , wherein the PTH spray is comprised of droplets of the PTH solution, wherein less than about 10% of the droplets are about 20 μm or less in size.