US2013171214A1PendingUtilityA1

Pharmaceutical Compositions

55
Individually held — no corporate assignee on recordPriority: Sep 16, 2010Filed: Sep 15, 2011Published: Jul 4, 2013
Est. expirySep 16, 2030(~4.1 yrs left)· nominal 20-yr term from priority
Inventors:Deepak B. MundhraRennan Pan
A61K 31/505A61K 31/4985A61P 31/00A61K 9/16A61P 31/18
55
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Claims

Abstract

The present Invention relates to pharmaceutical compositions of (3S,11aR)-N-[(2,4-difluorophenyl)methyl]-2,3,5,7,11,11a-hexahydro-6-hydroxy-3-methyl-5,7-dioxo-oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide, useful in the treatment or prevention of Human Immunodeficiency Virus (HIV) infections.

Claims

exact text as granted — not AI-modified
1 . A parenteral pharmaceutical composition comprising a compound of formula (I) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, and a surfactant system comprising a polysorbate and polyethylene glycol. 
     
     
         2 . A pharmaceutical composition according to  claim 1  for subcutaneous administration. 
     
     
         3 . A pharmaceutical composition according to  claim 1  for intramuscular administration. 
     
     
         4 . A pharmaceutical composition according to  claim 1  for once per month administration. 
     
     
         5 . A pharmaceutical composition according to  claim 1  for administration once every two months. 
     
     
         6 . A pharmaceutical composition according to  claim 1  for administration once every three months. 
     
     
         7 . A pharmaceutical composition according to  claim 1  for administration at any interval between 30 and 365 days. 
     
     
         8 . A pharmaceutical composition according to  claim 1  wherein the amount of a compound of formula (I) is from about 10 mg to about 500 mg per ml of the dosage form. 
     
     
         9 . A pharmaceutical composition according to  claim 1  wherein the particle size is less than or equal to 200 nm. 
     
     
         10 . A pharmaceutical composition according to  claim 1  wherein the particle size is in the range of 0.1-0.5 μm. 
     
     
         11 . A pharmaceutical composition according to  claim 1  that can be terminally sterilized by gamma irradiation. 
     
     
         12 . A method for the treatment of an HIV infection in a human comprising administering a pharmaceutical composition according to  claim 1 . 
     
     
         13 . A method for the prevention of an HIV infection in a human comprising administering a pharmaceutical composition according to  claim 1 . 
     
     
         14 . (canceled) 
     
     
         15 . (canceled) 
     
     
         16 . A pharmaceutical composition according to  claim 1  comprising 0.1-10% polysorbate 20 and 0.1-10% polyethylene glycol. 
     
     
         17 . A parenteral pharmaceutical composition for administration once every one to three months, comprising 0.1-50% by weight of a compound of formula (I) 
       
         
           
           
               
               
           
         
       
       0.1-10% polysorbate 20, and 0.1-10% polyethylene glycol, and wherein the mean particle size of said composition is 0.1-1.0 μm. 
     
     
         18 . A pharmaceutical composition according to  claim 17  wherein the particle size is 200 nm. 
     
     
         19 . A pharmaceutical composition according to  claim 17  for subcutaneous or intramuscular administration. 
     
     
         20 . A method for the treatment of an HIV infection in a human comprising administering a pharmaceutical composition according to  claim 17 . 
     
     
         21 . A method for the prevention of an HIV infection in a human comprising administering a pharmaceutical composition according to  claim 17 . 
     
     
         22 . A combination of a parenteral pharmaceutical composition for administration once every 1 to 3 months comprising a compound of formula (I) 
       
         
           
           
               
               
           
         
       
       and rilpivirine hydrochloride.

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