Compositions and methods involving polymer, solvent, and high viscosity liquid carrier material

Abstract

Compositions may include a pharmaceutical active agent, a high viscosity liquid carrier material (HVLCM), a lactic acid-based polymer, and an organic solvent. Related compositions and methods are also disclosed.

What is claimed is: 
     
         1 . A composition comprising:
 5 wt % to 20 wt %, based on total weight of the composition, of particles comprising pharmaceutical active agent that is risperidone or pharmaceutically acceptable salt thereof, the particles having a median particle size, as measured by laser diffraction, ranging from 0.5 micrometer to 7 micrometers;   30 wt % to 60 wt %, based on total weight of the composition, of a non-polymeric, non-water soluble high viscosity liquid carrier material (HVLCM) having a viscosity of at least 5000 cP at 37° C. that does not crystallize neat at 25° C. and 1 atmosphere, wherein the HVLCM is sucrose acetate isobutyrate;   5 wt % to 30 wt %, based on total weight of the composition, of a lactic acid based-polymer that is poly(lactic acid)(glycolic acid) comprising an alkoxy end group, the poly(lactic acid)(glycolic acid) having a lactic acid to glycolic acid molar ratio ranging from 95:5 to 60:40, the poly(lactic acid)(glycolic acid) having a weight average molecular weight ranging from 4000 Daltons to 15,000 Daltons; and   10 wt % to 40 wt %, based on total weight of the composition, of a solvent that is at least one member selected from N-methyl-pyrrolidone, propylene carbonate, and dimethylsulfoxide.   
     
     
         2 . The composition of  claim 1 , which is a gamma-irradiated composition. 
     
     
         3 . The composition of  claim 1 , wherein a weight ratio of the HVLCM to the lactic acid-based polymer to the solvent ranges from 1:0.25-0.5:0.4-0.8. 
     
     
         4 . The composition of  claim 1 , wherein the composition has a viscosity ranging from 50 cP to 2000 cP. 
     
     
         5 . The composition of  claim 1 , wherein the alkoxy end group consists of 8 to 24 carbons. 
     
     
         6 . The composition of  claim 5 , wherein the alkoxy end group consists of 12 carbons. 
     
     
         7 . The composition of  claim 5 , wherein the lactic acid-based polymer is initiated with a fatty alcohol. 
     
     
         8 . The composition of  claim 5 , wherein the lactic-acid based polymer is initiated with dodecanol. 
     
     
         9 . The composition of  claim 1 , wherein the solvent comprises N-methyl-pyrrolidone. 
     
     
         10 . The composition of  claim 1 , wherein the solvent comprises propylene carbonate. 
     
     
         11 . The composition of  claim 1 , wherein the solvent comprises dimethylsulfoxide. 
     
     
         12 . The composition of  claim 2 , wherein the solvent comprises N-methyl-pyrrolidone. 
     
     
         13 . The composition of  claim 2 , wherein the solvent comprises propylene carbonate. 
     
     
         14 . The composition of  claim 2 , wherein the solvent comprises dimethylsulfoxide. 
     
     
         15 . The composition of  claim 4 , wherein the solvent comprises N-methyl-pyrrolidone. 
     
     
         16 . The composition of  claim 4 , wherein the solvent comprises propylene carbonate. 
     
     
         17 . The composition of  claim 4 , wherein the solvent comprises dimethylsulfoxide. 
     
     
         18 . The composition of  claim 5 , wherein the solvent comprises N-methyl-pyrrolidone. 
     
     
         19 . The composition of  claim 5 , wherein the solvent comprises propylene carbonate. 
     
     
         20 . The composition of  claim 5 , wherein the solvent comprises dimethylsulfoxide.