US2019216828A1PendingUtilityA1

Composition for Inhalation

71
Assignee: ASTRAZENECA ABPriority: Feb 1, 2002Filed: Aug 22, 2018Published: Jul 18, 2019
Est. expiryFeb 1, 2022(expired)· nominal 20-yr term from priority
Inventors:Nayna GovindMaria Marlow
A61K 31/573A61K 47/34A61P 11/06A61K 31/167A61K 31/194A61P 11/08A61K 47/32A61K 9/008A61P 11/02A61K 31/58A61P 11/00A61K 9/00
71
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Claims

Abstract

The invention relates to a formulation comprising formoterol and budesonide for use in the treatment of respiratory diseases. The composition further contains HFA 227, PVP and PEG, preferably PVP K25 and PEG 1000.

Claims

exact text as granted — not AI-modified
1 .- 12 . (canceled) 
     
     
         13 . A stable pharmaceutical composition comprising
 formoterol;   budesonide or an epimer thereof;   1,1,1,2,3,3,3-heptafluoropropane (HFA 227);   polyvinylpyrrolidone (PVP); and   polyethylene glycol (PEG),   
       wherein the formoterol and budesonide or an epimer thereof are present in concentrations effective for treating a respiratory disease in a patient in need thereof where the composition is delivered as a dose by actuation of a pressurized metered dose inhaler. 
     
     
         14 . The composition according to  claim 13  wherein the dose contains 4.5/40 mcg or 4.5/80 mcg or 4.5/160 mcg or 4.5/320 mcg of formoterol/budesonide. 
     
     
         15 . The composition according to  claim 13  wherein the PVP is present from about 0.0005 to about 0.05% w/w. 
     
     
         16 . The composition according to  claim 13  wherein the PVP is PVP K25. 
     
     
         17 . The composition according to  claim 13  wherein the PEG is present from about 0.05 to about 0.35% w/w. 
     
     
         18 . The composition according to  claim 13  wherein the PEG is PEG 1000. 
     
     
         19 . The composition according to  claim 13  wherein the PEG is present in an amount of 0.3% w/w. 
     
     
         20 . The composition according to  claim 13  wherein the formoterol is in the form of its fumarate dihydrate salt. 
     
     
         21 . The composition according to  claim 13  wherein the formoterol is in the form of its R, R-enantiomer. 
     
     
         22 . The composition according to  claim 13  wherein the budesonide or an epimer thereof is the 22R-epimer of budesonide. 
     
     
         23 . The composition according to  claim 13  wherein the respiratory disease is asthma, rhinitis or chronic obstructive pulmonary disease (COPD).

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