Powdered formulations of cromolyn sodium and ibuprofen

Abstract

The invention is directed to a composition comprising cromolyn sodium and ibuprofen, wherein the cromolyn sodium is micronized and the cromolyn sodium and ibuprofen are present in a weight ratio of 1:1-2. In one embodiment, the ibuprofen is passed through a sieve, such as a 300 μm sieve and to methods of making the same.

1 - 18 . (canceled) 
     
     
         19 . A composition comprising cromolyn or a pharmaceutically acceptable salt or ester thereof and ibuprofen, wherein the composition is capable of being delivered using a device that deposits from 36% to 56% by weight of the administered amount of cromolyn or the pharmaceutically acceptable salt or ester thereof to a Stage 3 micro-orifice collector (MOC) of a Next Generation Pharmaceutical Impactor (NGI) cascade impactor device at a flow rate of 80 L/min for 3 seconds. 
     
     
         20 . The composition of  claim 19 , wherein cromolyn or a pharmaceutically acceptable salt or ester thereof is in the form of micronized particles; and wherein the cromolyn particle size distribution D 90  is ≤5μm. 
     
     
         21 . The composition of  claim 19 , wherein ibuprofen in the form of coarse particles; and
 wherein the coarse particle size distribution D 10  is about 22 μm, D 50  is about 58 μm, and D 90  is about 109 μm.   
     
     
         22 . The composition of  claim 19 , wherein ibuprofen is in the form of micronized particles; and wherein the average particle size of the ibuprofen is from about 2 μm to about 5 μm. 
     
     
         23 . The composition of  claim 19 , further comprising one or more pharmaceutically acceptable excipients. 
     
     
         24 . The composition of  claim 23 , wherein the excipient is lactose monohydrate or magnesium stearate. 
     
     
         25 . The composition of  claim 23 , wherein the excipient is magnesium stearate, and wherein the amount of magnesium stearate in the composition is 2% (w/w). 
     
     
         26 . The composition of  claim 19 , wherein the composition comprises from about 17 mg to about 24 mg of cromolyn or a pharmaceutically acceptable salt or ester thereof. 
     
     
         27 . The composition of  claim 19 , wherein the composition comprises about 17.1 mg of cromolyn or a pharmaceutically acceptable salt or ester thereof. 
     
     
         28 . The composition of  claim 19 , wherein cromolyn is cromolyn sodium. 
     
     
         29 . The composition of  claim 19 , wherein the composition comprises from about 10 mg to about 14 mg of ibuprofen. 
     
     
         30 . The composition of  claim 19 , wherein the device is a dry powder inhaler (DPI). 
     
     
         31 . A method of treating or slowing the progression of a disease or condition in a human subject in need thereof comprising administering to the subject by inhalation the composition of  claim 19 , wherein the disease or condition is Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, stroke, or asthma. 
     
     
         32 . The method of  claim 31 , wherein the disease or condition is Alzheimer's disease. 
     
     
         33 . The method of  claim 31 , wherein the disease or condition is amyotrophic lateral sclerosis. 
     
     
         34 . The method of  claim 31 , wherein the disease or condition is Parkinson's disease. 
     
     
         35 . The method of  claim 31 , wherein the disease or condition is stroke. 
     
     
         36 . The method of  claim 31 , wherein the wherein the disease or condition is asthma.