Compositions for respiratory delivery of active agents and associated methods and systems

Abstract

Compositions, methods and systems are provided for pulmonary or nasal delivery of active agents via a metered dose inhaler. In one embodiment, the compositions include a suspension medium, active agent particles, and suspending particles, in which the active agent particles and suspending particles form a co-suspension within the suspension medium.

1 .- 54 . (canceled) 
     
     
         55 . A pharmaceutical composition deliverable from a metered dose inhaler, the composition comprising:
 a pharmaceutically acceptable suspension medium;   a plurality of active agent particles selected from glycopyrrolate, formoterol and budesonide; and   a plurality of suspending particles comprising a phospholipid; wherein the concentration of the suspending particles is between about 1 mg/mL and about 15 mg/mL.   
     
     
         56 . The pharmaceutical composition of  claim 55 , wherein the pharmaceutically acceptable suspension medium is an HFA propellant. 
     
     
         57 . The pharmaceutical composition of  claim 56 , wherein the HFA propellant is HFA-134a. 
     
     
         58 . The pharmaceutical composition of  claim 55 , wherein the amount of glycopyrrolate in the pharmaceutical composition is between about 0.04 mg/mL and about 2.25 mg/mL. 
     
     
         59 . The pharmaceutical composition of  claim 55 , wherein the pharmaceutical composition comprises sufficient glycopyrrolate to provide a delivered dose of up to about 20 μg per actuation of the device. 
     
     
         60 . The pharmaceutical composition of  claim 55 , wherein the glycopyrrolate is 3-[(cyclopentyl-hydroxyphenylacetyloxy]-1,1-dimethylpyrrolidium bromide. 
     
     
         61 . The pharmaceutical composition of  claim 55 , wherein the amount of formoterol in the pharmaceutical composition is between about 0.01 mg/mL and about 1 mg/mL. 
     
     
         62 . The pharmaceutical composition of  claim 55 , wherein the pharmaceutical composition comprises sufficient formoterol to provide a delivered dose of between about 1 μg and about 30 μg formoterol per actuation of the device. 
     
     
         63 . The pharmaceutical composition of  claim 62 , wherein the pharmaceutical composition comprises sufficient formoterol to provide a delivered dose of between about 2 μg and about 10 μg formoterol per actuation of the device. 
     
     
         64 . The pharmaceutical composition of  claim 55 , wherein the formoterol is formoterol fumarate dihydrate. 
     
     
         65 . The pharmaceutical composition of  claim 55 , wherein the pharmaceutical composition comprises sufficient budesonide to provide a delivered dose of between about 30 μg and about 240 μg per actuation of the device. 
     
     
         66 . The pharmaceutical composition of  claim 55 , wherein the pharmaceutical composition comprises sufficient budesonide to provide a delivered dose of up to about 240 μg per actuation of the device. 
     
     
         67 . The pharmaceutical composition of  claim 55 , wherein the suspending particles comprise DSPC and calcium chloride. 
     
     
         68 . The pharmaceutical composition of  claim 55 , wherein the ratio of the total mass of the suspending particles to the total mass of the active agent particles is about 3:1.