Peroxide removal from drug delivery vehicle

Abstract

The present invention is related to methods for lowering peroxide levels in sucrose acetate isobutyrate formulations and to composition used in and formed by such methods.

1 .- 25 . (canceled) 
     
     
         26 . A formulation comprising:
 a drug;   sucrose acetate isobutyrate; and   peroxide,   
       wherein the peroxide is present in the formulation at a level ranging from 2.6 ppm to 20 ppm. 
     
     
         27 . The formulation of  claim 26 , wherein the peroxide is present in the formulation at a level ranging from 5 ppm to 20 ppm. 
     
     
         28 . The formulation of  claim 26 , wherein the peroxide is present in the formulation at a level ranging from 10 ppm and 20 ppm. 
     
     
         29 . The formulation of  claim 26 , wherein the peroxide is present in the formulation at a level ranging from 2.6 ppm to 10 ppm. 
     
     
         30 . The formulation of  claim 26 , wherein the peroxide is present in the formulation at a level ranging from 5 ppm to 10 ppm. 
     
     
         31 . The formulation of  claim 26 , wherein the drug is selected from peptides, polypeptides, proteins, nucleic acids, viruses, antibodies and small molecules susceptible to oxidation. 
     
     
         32 . The formulation of  claim 26 , wherein the drug is selected from steroids, NSAIDs, growth factors, hormones, anti-tumor agents, antibiotics, analgesics, local anesthetics, antiviral agents, antipsychotics, anticoagulants, and oligonucleotides for gene therapy. 
     
     
         33 . The formulation of  claim 26 , further comprising a pharmaceutically acceptable solvent. 
     
     
         34 . The formulation of  claim 26 , further comprising a solvent comprising hexane, ethyl acetate, ethanol, benzyl benzoate, N-methyl pyrrolidone, or isopropyl alcohol, or a combination thereof. 
     
     
         35 . The formulation of  claim 26 , further comprising N-methyl pyrrolidone. 
     
     
         36 . The formulation of  claim 26 , wherein the drug comprises a local anesthetic and further comprising N-methyl pyrrolidone. 
     
     
         37 . The formulation of  claim 26 , wherein the drug exhibits prolonged stability in the formulation, wherein the prolonged stability comprises reduced oxidation, reduced deamidation, or reduced aggregation of the drug relative to the drug in a second formulation comprising sucrose acetate isobutyrate and peroxide. 
     
     
         38 . The formulation of  claim 26 , wherein the drug exhibits prolonged stability in the formulation, wherein the prolonged stability is reduced oxidation of the drug relative to the drug in a second formulation comprising sucrose acetate isobutyrate and peroxide. 
     
     
         39 . A formulation comprising:
 a drug;   sucrose acetate isobutyrate; and   peroxide,   
       wherein the peroxide is present in the formulation at a level ranging from 2.6 ppm to 20 ppm, and 
       wherein the formulation is polymer-free. 
     
     
         40 . The formulation of  claim 39 , wherein the peroxide is present in the formulation at a level ranging from 5 ppm to 20 ppm. 
     
     
         41 . The formulation of  claim 39 , wherein the peroxide is present in the formulation at a level ranging from 2.6 ppm to 10 ppm. 
     
     
         42 . The formulation of  claim 39 , wherein the drug is selected from steroids, NSAIDs, growth factors, hormones, anti-tumor agents, antibiotics, analgesics, local anesthetics, antiviral agents, antipsychotics, anticoagulants, and oligonucleotides for gene therapy. 
     
     
         43 . The formulation of  claim 39 , further comprising a pharmaceutically acceptable solvent. 
     
     
         44 . The formulation of  claim 39 , further comprising N-methyl pyrrolidone. 
     
     
         45 . The formulation of  claim 39 , wherein the drug comprises a local anesthetic and further comprising N-methyl pyrrolidone. 
     
     
         46 . A method of prolonging drug stability in a formulation, comprising:
 maintaining peroxide in the formulation at a level ranging from 2.6 ppm to 20 ppm,   
       wherein the formulation comprises:
 a drug; 
 sucrose acetate isobutyrate; and 
 peroxide.