Method and composition for administering prostaglandins

Abstract

A method for treating migraines is disclosed. The method utilizes a rapid drug delivery system which prevents deactivation or degradation of the active agent, including small molecules and peptides being administered to a patient in need of treatment. In particular, the drug delivery system is designed for inhalation for delivery of drugs to the pulmonary circulation in a rapid and therapeutically effective manner.

We claim: 
     
         1 . A dry powder pharmaceutical composition comprising an effective amount of a prostaglandin or an analog thereof, and a diketopiperazine or a salt thereof. 
     
     
         2 . The dry powder pharmaceutical composition of  claim 1 , wherein the dry powder pharmaceutical composition is administered by inhalation. 
     
     
         3 . The dry powder pharmaceutical composition of  claim 1 , wherein said diketopiperazine comprises 3,6-di(4-X-aminobutyl)-2,5-diketopiperazine; wherein X is at least one of succinyl, glutaryl, maleyl, or fumaryl; or a pharmaceutically acceptable salt thereof. 
     
     
         4 . The dry powder pharmaceutical composition of  claim 1 , wherein the dry powder pharmaceutical composition is manufactured as an inhalable unit dose. 
     
     
         5 . The dry powder pharmaceutical composition of  claim 4 , wherein said inhalable unit dose further comprises a pharmaceutically acceptable carrier or excipient. 
     
     
         6 . The dry powder pharmaceutical composition of  claim 5 , wherein said inhalable unit dose is administered to said subject by pulmonary inhalation using a breath powered, dry powder inhalation system. 
     
     
         7 . The dry powder pharmaceutical composition of  claim 1 , wherein said prostaglandin is for treating moderate to severe pain. 
     
     
         8 . The dry powder pharmaceutical composition of  claim 7 , wherein said prostaglandin comprises PG-I2 or an analog thereof. 
     
     
         9 . The dry powder pharmaceutical composition of  claim 1 , wherein the dry powder pharmaceutical composition further comprises an aliphatic amino acid. 
     
     
         10 . The dry powder pharmaceutical composition of  claim 9 , wherein the aliphatic amino acid is at least one of alanine, glycine, leucine, isoleucine, norleucine, or serine. 
     
     
         11 . The dry powder pharmaceutical composition of  claim 9 , wherein the aliphatic amino acid comprises about 0.5% to about 30% by weight of the composition. 
     
     
         12 . The dry powder pharmaceutical composition of  claim 1 , wherein the dry powder pharmaceutical composition further comprises L-leucine. 
     
     
         13 . The dry powder pharmaceutical composition of  claim 1 , wherein the diketopiperazine comprises 3,6-bis[N-fumaryl-4-aminobutyl]-2,5-diketopiperazine or a salt thereof. 
     
     
         14 . The dry powder pharmaceutical composition of  claim 13 , wherein the diketopiperazine comprises 3,6-bis[(N-fumaryl-4-aminobutyl)]-2,5-diketopiperazine disodium salt. 
     
     
         15 . The dry powder pharmaceutical composition of  claim 6 , wherein the breath powered, dry powder inhalation system comprises a cartridge containing said dry powder pharmaceutical composition. 
     
     
         16 . A method of treating local lung disease comprising administering a dry powder composition comprising the pharmaceutical composition of  claim 8 .