US2014255497A1PendingUtilityA1

Organic Compounds

58
Assignee: OOMURA TOMOYUKIPriority: Apr 8, 2003Filed: May 23, 2014Published: Sep 11, 2014
Est. expiryApr 8, 2023(expired)· nominal 20-yr term from priority
Inventors:Tomoyuki OomuraMadhusudhan PudipeddiColleen RueggerAlan Edward RoyceMasaki SasakiTokuhiro Tamura
A61P 37/06A61P 41/00A61P 37/02A61P 43/00A61P 37/00A61P 9/00A61P 31/12A61P 25/28A61P 25/00A61P 31/00A61P 29/00A61K 47/26A61K 31/145A61K 9/2054A61K 9/4858A61K 9/2018A61K 45/06A61K 9/2013A61K 9/4866A61K 31/137A61K 31/138A61K 31/135A61K 47/10A61K 9/0053A61K 9/20A61K 9/48
58
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Claims

Abstract

A solid pharmaceutical composition suitable for oral administration, comprising: (a) S 1 P receptor agonist; and (b) a sugar alcohol.

Claims

exact text as granted — not AI-modified
1 . A solid pharmaceutical composition suitable for oral administration, comprising:
 (a) a therapeutically effective amount of a S1P receptor agonist, which is 2-amino-2-{2-[4-(3-benzyloxyphenylthio)-2-chlorophenyl]ethyl}-1,3-propanediol  or a pharmaceutically acceptable salt thereof, and   (b) a sugar alcohol.   
     
     
         2 . A composition according to  claim 1 , wherein the sugar alcohol comprises mannitol. 
     
     
         3 . A composition according to  claim 1 , further comprising a lubricant. 
     
     
         4 . A composition according to  claim 3 , wherein the lubricant composes magnesium stearate. 
     
     
         5 . A composition according to  claim 1 , comprising 0.5 to 5% by weight of the S1P receptor agonist. 
     
     
         6 . A composition according to  claim 1 , comprising 90 to 99.5% by weight of the sugar alcohol. 
     
     
         7 . A composition according to  claim 3 , comprising 1.5 to 2.5% by weight of the lubricant. 
     
     
         8 . A composition according to  claim 1 , in the form of a tablet. 
     
     
         9 . A composition according to  claim 1 , in the form of a capsule. 
     
     
         10 . A composition according to  claim 3 , comprising 0.01 to 5% by weight of the lubricant. 
     
     
         11 . A composition according to  claim 2 , wherein the S1P receptor agonist is micronized. 
     
     
         12 . A composition according to  claim 2 , wherein the S1P receptor agonist is pre-screened with a 400 to 500 μm mesh screen. 
     
     
         13 . A method of treating multiple sclerosis in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of a pharmaceutical composition according to  claim 2 . 
     
     
         14 . A method of treating multiple sclerosis in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of a pharmaceutical composition according to  claim 1 . 
     
     
         15 . A composition according to  claim 2 , wherein the mannitol has a mean particle size of 100 to 300 μm. 
     
     
         16 . A composition according to  claim 2 , wherein the mannitol has a mean particle size of 150 to 250 μm. 
     
     
         17 . A composition according to  claim 2 , wherein the mannitol has a bulk density of 0.4 to 0.6 g/ml. 
     
     
         18 . A composition according to  claim 2 , wherein the mannitol has a bulk density of 0.45 to 0.55 g/ml. 
     
     
         19 . A composition according to  claim 2 , wherein the mannitol has a single point surface area of 1 m 2 /g to 7 m 2 /g. 
     
     
         20 . A composition according to  claim 2 , wherein the S1P receptor agonist is 2-amino-2-{2-[4-(3-benzyloxyphenylthio)-2-chlorophenyl]ethyl}-1,3-propanediol hydrochloride.

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