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. For instance, a carrier formulation for controlled release of injectable drugs is disclosed. The formulation may include a non-water soluble high viscosity liquid which may be sucrose acetate isobutyrate, a lactic-acid based polymer which may be a poly(lactic acid)(glycolic acid), and an organic solvent which maintains the composition in a monophasic form at 25° C. in one atmosphere. Drug in the formulation may be released upon administration such that less than 10% (e.g. 2-8%) of drug is released in the first 5 hours; 10% to 80% of the drug is released during a period of 5 hours to 7 days after administration; and 10% to 40% of the drug is released gradually over a period of 7 days to 28 days from initial administration. The drug may be an anti-schizophrenia agent delivered by injection.

1 - 23 . (canceled) 
     
     
         24 . A composition comprising:
 a pharmaceutical active agent;   10 wt % to 80 wt %, based on total weight of the composition, of sucrose acetate isobutyrate;   1 wt % to 30 wt %, based on total weight of the composition, of a lactic acid-based polymer comprising an alkoxy end group having 8 to 24 carbons, the lactic acid-based polymer having a lactic acid to glycolic acid molar ratio ranging from 100:0 to 40:60; and   5 wt % to 60 wt %, based on total weight of the composition, of an organic solvent.   
     
     
         25 . The composition of  claim 24 , wherein the sucrose acetate isobutyrate is present in an amount ranging from 30 wt % to 80 wt %, based on total weight of the composition. 
     
     
         26 . The composition of  claim 24 , wherein the lactic acid-based polymer is present in an amount ranging from 5 wt % to 30 wt %, based on total weight of the composition. 
     
     
         27 . The composition of  claim 24 , wherein the organic solvent is present in an amount ranging from 5 wt % to 30 wt %, based on total weight of the composition. 
     
     
         28 . The composition of  claim 24 , wherein the organic solvent comprises at least one member selected from N-methyl-pyrrolidone, dimethylsulfoxide, propylene carbonate, and benzyl benzoate. 
     
     
         29 . The composition of  claim 26 , wherein the sucrose acetate isobutyrate is present in an amount ranging from 30 wt % to 80 wt %, based on total weight of the composition. 
     
     
         30 . The composition of  claim 27 , wherein the sucrose acetate isobutyrate is present in an amount ranging from 30 wt % to 80 wt %, based on total weight of the composition. 
     
     
         31 . (Proposed) The composition of  claim 28 , wherein the sucrose acetate isobutyrate is present in an amount ranging from 30 wt % to 80 wt %, based on total weight of the composition. 
     
     
         32 . The composition of  claim 27 , wherein the lactic acid-based polymer is present in an amount ranging from 5 wt % to 30 wt %, based on total weight of the composition. 
     
     
         33 . The composition of  claim 28 , wherein the lactic acid-based polymer is present in an amount ranging from 5 wt % to 30 wt %, based on total weight of the composition. 
     
     
         34 . The composition of  claim 29 , wherein the lactic acid-based polymer is present in an amount ranging from 5 wt % to 30 wt %, based on total weight of the composition. 
     
     
         35 . The composition of  claim 30 , wherein the lactic acid-based polymer is present in an amount ranging from 5 wt % to 30 wt %, based on total weight of the composition. 
     
     
         36 . The composition of  claim 31 , wherein the lactic acid-based polymer is present in an amount ranging from 5 wt % to 30 wt %, based on total weight of the composition. 
     
     
         37 . The composition of  claim 28 , wherein the organic solvent is present in an amount ranging from 5 wt % to 30 wt %, based on total weight of the composition. 
     
     
         38 . The composition of  claim 29 , wherein the organic solvent is present in an amount ranging from 5 wt % to 30 wt %, based on total weight of the composition. 
     
     
         39 . The composition of  claim 30 , wherein the organic solvent is present in an amount ranging from 5 wt % to 30 wt %, based on total weight of the composition. 
     
     
         40 . The composition of  claim 29 , wherein the organic solvent comprises at least one member selected from N-methyl-pyrrolidone, dimethylsulfoxide, propylene carbonate, and benzyl benzoate. 
     
     
         41 . The composition of  claim 30 , wherein the organic solvent comprises at least one member selected from N-methyl-pyrrolidone, dimethylsulfoxide, propylene carbonate, and benzyl benzoate. 
     
     
         42 . The composition of  claim 31 , wherein the organic solvent comprises at least one member selected from N-methyl-pyrrolidone, dimethylsulfoxide, propylene carbonate, and benzyl benzoate. 
     
     
         43 . The composition of  claim 32 , wherein the organic solvent comprises at least one member selected from N-methyl-pyrrolidone, dimethylsulfoxide, propylene carbonate, and benzyl benzoate.