Pharmaceutical compositions

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.

1 . A method for the treatment of an HIV infection in a human comprising administering a pharmaceutical suspension wherein the suspension comprises
 0.1-50% by weight a compound of formula (I)   
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, 
         0.1-10% by weight polysorbate, 
         0.1-10% by weight polyethylene glycol 3350, 4000 or 8000, 
         mannitol, and 
         water, 
       
       wherein the suspension has mean particle size of 0.1-0.5 μm, 
       wherein the suspension has been sterilized by gamma irradiation; and 
       wherein the administration is parenteral administration. 
     
     
         2 . The method according to  claim 1 , wherein the parenteral administration is subcutaneous administration. 
     
     
         3 . The method according to  claim 1 , wherein the parenteral administration is intramuscular administration. 
     
     
         4 . The method according to  claim 1 , wherein the parenteral administration is a once per month administration. 
     
     
         5 . The method according to  claim 1 , wherein the parenteral administration is a once every two months administration. 
     
     
         6 . The method according to  claim 1 , wherein the parenteral administration is a once every three months administration. 
     
     
         7 . The method according to  claim 1 , wherein the parenteral administration is at any interval between 30 and 365 days. 
     
     
         8 . The method according to  claim 1 , wherein the polyethylene glycol is 3350. 
     
     
         9 . The method according to  claim 1 , wherein the suspension comprises
 200 mg/mL compound of formula (I),   45 mg/mL mannitol,   20 mg/mL polysorbate 20,   20 mg/mL PEG 3350, and   QS to 1 mL water.