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 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 a powder composition, wherein:
 the disease or condition is Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, stroke, or asthma;   the powder composition comprises cromolyn sodium and ibuprofen;   the cromolyn sodium is in the form of micronized particles;   the ibuprofen is in the form of coarse particles; and   the cromolyn sodium and ibuprofen are present in a weight ratio of 1.7:1 or 1:1-2.   
     
     
         20 . The method of  claim 19 , wherein when the composition is delivered using a device to a Next Generation Pharmaceutical Impactor cascade impactor (NGI) at a flow rate of 80 L/min for 3 seconds, from 36% to 56% by weight of the delivered amount of cromolyn sodium is deposited to Stages 3 through micro-orifice collector of the NGI. 
     
     
         21 . The method of  claim 20 , wherein the device is a dry powder inhaler (DPI). 
     
     
         22 . The method of  claim 19 , wherein the cromolyn sodium particle size distribution D 90  is ≤5 μm. 
     
     
         23 . The method of  claim 19 , wherein the ibuprofen particle size distribution D 10  is about 22 μm, D 50  is about 58 μm, and D 90  is about 109 μm. 
     
     
         24 . The method of  claim 19 , wherein the composition further comprises one or more pharmaceutically acceptable excipients. 
     
     
         25 . The method of  claim 24 , wherein the one or more excipient is lactose monohydrate or magnesium stearate. 
     
     
         26 . The method of  claim 24 , wherein the one or more excipient is magnesium stearate, and wherein the amount of magnesium stearate in the composition is 2% (w/w). 
     
     
         27 . The method of  claim 19 , wherein the composition comprises from 17 mg to 24 mg of cromolyn sodium. 
     
     
         28 . The method of  claim 19 , wherein the composition comprises 17.1 mg of cromolyn sodium. 
     
     
         29 . The method of  claim 19 , wherein the composition comprises from 10 mg to 14 mg of ibuprofen. 
     
     
         30 . The method of  claim 19 , wherein the cromolyn sodium and ibuprofen are present in a weight ratio of 1.7:1. 
     
     
         31 . The method of  claim 19 , wherein the cromolyn sodium and ibuprofen are present in a weight ratio of 1:1-2. 
     
     
         32 . The method of  claim 19 , wherein the disease or condition is Alzheimer's disease. 
     
     
         33 . The method of  claim 19 , wherein the disease or condition is amyotrophic lateral sclerosis. 
     
     
         34 . The method of  claim 19 , wherein the disease or condition is Parkinson's disease. 
     
     
         35 . The method of  claim 19 , wherein the disease or condition is stroke. 
     
     
         36 . The method of  claim 19 , wherein the disease or condition is asthma.