Intrathecal baclofen pharmaceutical dosage forms and related delivery system

Abstract

According to the subject invention, there is disclosed, a dosage and packaging configuration which includes the use of color-coded pre-filled syringes and vials to fill and refill infusion systems with existing and new dosage forms of intrathecal baclofen.

What is claimed is: 
     
         1 . A drug delivery system comprising a labeled pre-filled syringe containing a sterile aqueous solution of baclofen that is suitable for intrathecal delivery, wherein the sterile aqueous solution of baclofen was sterilized by heating at 121° C. for a F 0  value of 7 minutes. 
     
     
         2 . The drug delivery system of  claim 1 , wherein the sterile aqueous solution of baclofen contains no more than 0.5% of 4-(4-chlorophenyl)-2-pyrrolidone by weight of baclofen. 
     
     
         3 . The drug delivery system of  claim 1 , wherein the sterile aqueous solution of baclofen further comprises sodium chloride. 
     
     
         4 . The drug delivery system of  claim 1 , wherein the sterile aqueous solution of baclofen is substantially free of any particulates. 
     
     
         5 . The drug delivery system of  claim 1 , wherein the sterile aqueous solution of baclofen has a baclofen concentration from about 0.5 mg/mL to about 4.0 mg/mL. 
     
     
         6 . The drug delivery system of  claim 5 , wherein the labeled pre-filled syringe contains from 5 mL to 40 mL of the sterile aqueous solution of baclofen. 
     
     
         7 . The drug delivery system of  claim 5 , further comprising a color-coding system indicative of the concentration of baclofen in the labeled pre-filled syringe, size of the pre-filled syringe, or both. 
     
     
         8 . The drug delivery system of  claim 7 , further comprising a plunger, wherein the color-coding system is on the plunger, on a label of the labeled pre-filled syringe, or both. 
     
     
         9 . The drug delivery system of  claim 1 , wherein the labeled pre-filled syringe further comprises a leur-lock tip. 
     
     
         10 . A drug delivery system comprising a labeled pre-filled syringe containing a sterile aqueous solution of baclofen that is suitable for intrathecal delivery, wherein the sterile aqueous solution of baclofen contains no more than 0.5% of 4-(4-chlorophenyl)-2-pyrrolidone by weight of baclofen. 
     
     
         11 . The drug delivery system of  claim 10 , wherein the sterile aqueous solution of baclofen further comprises sodium chloride. 
     
     
         12 . The drug delivery system of  claim 10 , wherein the sterile aqueous solution of baclofen is substantially free of any particulates. 
     
     
         13 . The drug delivery system of  claim 10 , wherein the sterile aqueous solution of baclofen has a baclofen concentration from about 0.5 mg/mL to about 4.0 mg/mL. 
     
     
         14 . The drug delivery system of  claim 13 , wherein the labeled pre-filled syringe contains from 5 mL to 40 mL of the sterile aqueous solution of baclofen. 
     
     
         15 . The drug delivery system of  claim 13 , further comprising a color-coding system indicative of the concentration of baclofen in the labeled pre-filled syringe, size of the pre-filled syringe, or both. 
     
     
         16 . The drug delivery system of  claim 15 , further comprising a plunger, wherein the color-coding system is on the plunger, on a label of the labeled pre-filled syringe, or both. 
     
     
         17 . The drug delivery system of  claim 10 , wherein the labeled pre-filled syringe further comprises a leur-lock tip.