Delivery of active agents

Abstract

A method of introducing a physiologically-active agent into the circulatory system of a mammal is disclosed herein. The method utilizes a rapid drug delivery system which prevents deactivation or degradation of the active agent being administered to a patient in need of treatment. In particular, the drug delivery system is designed for pulmonary drug delivery such as by inhalation, for delivery of the active agents such as proteins and peptides to the pulmonary circulation in a therapeutically effective manner avoiding degradation of the active agents in peripheral and vascular tissue before reaching the target site.

1 .- 12 . (canceled) 
     
     
         13 . A drug delivery system for inhalation and treating a disease or disorder in a patient comprising a dry powder inhaler and an inhalable dry powder formulation comprising, microparticles of a labile vasoactive agent, polysorbate 80, and one or more pharmaceutically acceptable carrier or excipient, wherein the vasoactive agent is in an amount of about 0.05 mg (wt %) to about 5 mg (wt %) in the formulation and about 35% to 75% of the microparticles have an aerodynamic diameter of less than 5.8 um. 
     
     
         14 . The drug delivery system of  claim 13 , wherein the dry powder formulation further comprising a sugar. 
     
     
         15 . The drug delivery system of  claim 13 , wherein the labile vasoactive agent is a prostaglandin. 
     
     
         16 . The drug delivery system of  claim 13 , wherein the prostaglandin is PG 12. 
     
     
         17 . The drug delivery system of  claim 13 , wherein the one or more pharmaceutical carrier or excipient is a diketopiperazine. 
     
     
         18 . The drug delivery system of  claim 13 , wherein said diketopiperazine is 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine; wherein X is selected from the group consisting of succinyl, glutaryl, maleyl and fumaryl; or a pharmaceutically acceptable salt thereof. 
     
     
         19 . The drug delivery system of  claim 13 , wherein the labile vasoactive agent is subject to degradation when administered to said patient as a result of exposure to peripheral tissue, vascular venous tissue, or liver metabolism, and wherein the effectiveness of said labile vasoactive agent is reduced by said degradation prior to reaching the vascular agent's site of action. 
     
     
         20 . The drug delivery system of  claim 13 , wherein the inhalable dry powder formulation is administered using a breath-powered dry powder inhaler. 
     
     
         21 . A drug delivery system for inhalation and treating a disease or disorder in a patient comprising a dry powder inhaler and an inhalable dry powder formulation comprising, microparticles of a prostaglandin, polysorbate 80, one or more pharmaceutically acceptable carrier or excipient and further comprising a sugar, wherein prostaglandin is in an amount of about 0.05 mg (wt %) to about 5 mg (wt %) in the formulation and about 35% to 75% of the microparticles have an aerodynamic diameter of less than 5.8 um. 
     
     
         22 . The drug delivery system of  claim 21 , wherein the prostaglandin is PG 12. 
     
     
         23 . The drug delivery system of  claim 21 , wherein the one or more pharmaceutical carrier or excipient is a diketopiperazine. 
     
     
         24 . The drug delivery system of  claim 21 , wherein said diketopiperazine is 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine; wherein X is selected from the group consisting of succinyl, glutaryl, maleyl and fumaryl; or a pharmaceutically acceptable salt thereof. 
     
     
         25 . A method of treating a disease or disorder in a patient in need thereof comprising providing the drug delivery system of  claim 13  and administering to said patient the inhalable dry powder by oral inhalation.