US2003096840A1PendingUtilityA1

Granule formulation

41
Priority: Oct 26, 2001Filed: Oct 24, 2002Published: May 22, 2003
Est. expiryOct 26, 2021(expired)· nominal 20-yr term from priority
Inventors:Brian Down
A61P 31/12A61P 43/00A61P 37/08A61P 25/06A61P 27/16A61P 27/02A61P 11/02A61P 11/06A61P 17/00A61P 11/00A61P 17/04A61K 9/1676A61K 9/1652A61K 9/1623A61K 9/16
41
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Claims

Abstract

The present invention relates to oral granules of montelukast sodium.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . Oral granules of montelukast sodium.  
     
     
         2 . Oral granules of montelukast sodium comprising a pharmaceutically acceptable substrate coated with montelukast sodium.  
     
     
         3 . Oral granules of montelukast sodium comprising a free-flowing pharmaceutically acceptable substrate coated with montelukast sodium.  
     
     
         4 . Oral granules of  claim 2  wherein said substrate is spray-dried mannitol.  
     
     
         5 . Oral granules of  claim 2  wherein said substrate is Pearlitol SD 200.  
     
     
         6 . Oral granules of  claim 4  wherein said substrate is spray-dried mannitol further agglomerated with a pharmaceutically acceptable binder.  
     
     
         7 . Oral granules of  claim 6  wherein said binder is selected from hydroxypropyl cellulose, hydroxypropyl methylcellulose, methylcellulose, ethylcellulose, polyvinylpyrrolidone.  
     
     
         8 . Oral granules of  claim 7  wherein said binder is hydroxypropyl cellullose.  
     
     
         9 . A flowable and dispersible pharmaceutical composition which comprises granules comprising a pharmaceutically acceptable substrate coated with montelukast sodium, and a pharmaceutically acceptable lubricant.  
     
     
         10 . A composition of  claim 9  wherein said granules comprise a free-flowing pharmaceutically acceptable substrate coated with montelukast sodium.  
     
     
         11 . A composition of  claim 9  wherein said granules comprise spray-dried mannitol coated with montelukast sodium.  
     
     
         12 . A composition of  claim 9  wherein said granules comprise Pearlitol SD 200 coated with montelukast sodium.  
     
     
         13 . A composition of  claim 9  wherein said granules comprise spray-dried mannitol further agglomerated with a pharmaceutically acceptable binder, and coated with montelukast sodium.  
     
     
         14 . A composition of  claim 9  wherein said binder is selected from hydroxypropyl cellulose, hydroxypropyl methylcellulose, methylcellulose, ethylcellulose, polyvinylpyrrolidone.  
     
     
         15 . A composition of  claim 14  wherein said binder is hydroxypropyl cellullose.  
     
     
         16 . A compositon of  claim 9  wherein said lubricant is magnesium stearate or talc.  
     
     
         17 . A composition of  claim 9  wherein said lubricant is magnesium stearate.  
     
     
         18 . A compositon of  claim 11  wherein said lubricant is magnesium stearate.  
     
     
         19 . A composition of  claim 12  wherein said lubricant is magnesium stearate.  
     
     
         20 . A composition of  claim 13  wherein said lubricant is magnesium stearate.

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