US2014171481A1PendingUtilityA1

Solid compositions

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Assignee: ABBVIE INCPriority: Jun 10, 2010Filed: Feb 14, 2014Published: Jun 19, 2014
Est. expiryJun 10, 2030(~3.9 yrs left)· nominal 20-yr term from priority
Inventors:Bernd LiepoldTina JungPeter H?LigRudolf SchroederNancy E. SeverJustin S. LafountaineBrent D. SinclairYi GaoJianwei Wu
A61P 31/14A61P 31/12A61K 9/1617A61K 9/1635A61K 9/2054A61K 9/2027A61K 9/1694A61K 31/4025A61K 31/00A61K 9/146
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Claims

Abstract

The present invention features solid compositions comprising amorphous Compound I. For instance, Compound I may be formulated in an amorphous solid dispersion which comprises a pharmaceutically acceptable hydrophilic polymer and preferably a pharmaceutically acceptable surfactant.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A process of making a solid pharmaceutical dosage form, comprising drying a liquid solution to form a solid composition, wherein said liquid solution comprises:
 (1) dimethyl(2S,2′S)-1,1′-((2S,2′S)-2,2′-(4,4′-((2S,5S)-1-(4-tert-butylphenyl)pyrrolidine-2,5-diyl)bis(4,1-phenylene))bis(azanediyl)bis(oxomethylene)bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl)dicarbamate (   
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof;
 (2) a pharmaceutically acceptable hydrophilic polymer; and 
 (3) a pharmaceutically acceptable surfactant, 
 
       and wherein said Compound I or salt is in an amorphous form in said solid composition. 
     
     
         2 . The process of  claim 1 , wherein said solid composition is a solid dispersion which includes:
 (1) said Compound I or salt,   (2) said polymer, and   (3) said surfactant.   
     
     
         3 . The process of  claim 2 , wherein said polymer has a T g  of at least 50° C. 
     
     
         4 . The process of  claim 3 , wherein said surfactant has a HLB value of at least 10. 
     
     
         5 . The process of  claim 2 , wherein said solid dispersion is an amorphous solid dispersion. 
     
     
         6 . The process of  claim 2 , wherein said polymer is copovidone, and said surfactant is D-alpha-tocopheryl polyethylene glycol 1000 succinate. 
     
     
         7 . The process of  claim 6 , wherein said solid dispersion is an amorphous solid dispersion. 
     
     
         8 . The process of  claim 1 , wherein said dosage form further comprises another anti-HCV agent. 
     
     
         9 . The process of  claim 1 , wherein said dosage form further comprises an HCV protease inhibitor. 
     
     
         10 . The process of  claim 1 , wherein said dosage form further comprises an MY polymerase inhibitor. 
     
     
         11 . A process of making a solid pharmaceutical dosage form, comprising solidifying a melt, wherein said melt comprises:
 (1) dimethyl(2S,2′S)-1,1′-((2S,2′S)-2,2′-(4,4′-((2S,5S)-1-(4-tert-butylphenyl)pyrrolidine-2,5-diyl)bis(4,1-phenylene))bis(azanediyl)bis(oxomethylene)bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl)dicarbamate (   
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof;
 (2) a pharmaceutically acceptable hydrophilic polymer; and 
 (3) a pharmaceutically acceptable surfactant. 
 
       and wherein said Compound I or salt is in an amorphous form in the solidified melt. 
     
     
         12 . The process of  claim 11 , wherein the solidified melt is a solid dispersion which includes:
 (1) said Compound I or salt,   (2) said polymer, and   (3) said surfactant.   
     
     
         13 . The process of  claim 12 , wherein said polymer has a T g  of at least 50° C. 
     
     
         14 . The process of  claim 13 , wherein said surfactant has a HLB value of at least 10. 
     
     
         15 . The process of  claim 12 , wherein said solid dispersion is an amorphous solid dispersion. 
     
     
         16 . The process of  claim 12 , wherein said polymer is copovidone, and said surfactant is D-alpha-tocopheryl polyethylene glycol 1000 succinate. 
     
     
         17 . The process of  claim 16 , wherein said solid dispersion is an amorphous solid dispersion. 
     
     
         18 . The process of  claim 11 , wherein said dosage form further comprises another anti-HCV agent. 
     
     
         19 . The process of  claim 11 , wherein said dosage form further comprises an HCV protease inhibitor. 
     
     
         20 . The process of  claim 11 , wherein said dosage form further comprises an HCV polymerase inhibitor.

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