Pulmonary delivery of active fragments parathyroid hormone

Abstract

Systemic delivery of parathyroid hormone to a mammalian host is accomplished by inhalation through the mouth of a dispersion of an N-terminal fragment of PTH. It has been found that such respiratory delivery of the PTH fragment provides a pulsatile concentration profile of the PTH in the host's serum. PTH fragment compositions include dry powder formulations having the PTH present in a dry bulking powder, liquid solutions or suspensions suitable for nebulization, and aerosol propellants suitable for use in a metered dose inhaler.

1 . A therapeutic dried composition in solid dose form suitable for transmucosal delivery, comprising a stabilizing polyol and a bioactive agent wherein the composition provides quick release of the bioactive agent after administration.  
     
     
         2 . The composition, according to  claim 1 , wherein the composition is freeze-dried, vacuum-dried, or spray-dried.  
     
     
         3 . The composition, according to  claim 1 , wherein the bioactive agent is a pharmaceutical agent, a hormone, a hormone fragment, a hormone analog, or a combination of any of the foregoing.  
     
     
         4 . The composition of  claim 1  wherein the stabilizing polyol comprises a monosaccharide.  
     
     
         5 . The composition of  claim 1  wherein the composition comprises a powder.  
     
     
         6 . The composition of  claim 5  wherein the powder comprises a particle size range of about 0.5 microns to about 5 microns.  
     
     
         7 . The composition of  claim 1  wherein the delivery comprises pulmonary or respiratory administration.  
     
     
         8 . The composition according to  claim 7 , wherein said pulmonary or respiratory administration results in a pulsatile serum concentration profile characterized by a rapid rise to a peak and followed by a rapid fall.  
     
     
         9 . A therapeutic composition in liquid form suitable for pulmonary or respiratory delivery, comprising a buffer and a bioactive agent wherein the composition provides quick release of the bioactive agent and a high level of bioavailability after administration.  
     
     
         10 . The composition, according to  claim 9 , wherein the buffer is an organic acid.