Hyaluronic acid formulation containing pyruvate

Abstract

Pyruvate may be used to stabilize hyaluronic acid compositions. For example, these compositions may have improved heat and/or storage stability.

What is claimed is: 
     
         1 . A composition comprising:
 a hyaluronic acid or a salt thereof, pyruvic acid or a salt thereof, and Vitamin C or a derivative thereof,   wherein the hyaluronic acid or its salt is crosslinked,   wherein the composition is suitable for use as a dermal filler, and   wherein the composition is a gel that is stable to heat sterilization.   
     
     
         2 . The composition of  claim 1 , wherein the gel has improved thermal stability as compared to a substantially identical gel lacking pyruvate. 
     
     
         3 . The composition of  claim 1 , wherein the gel has a ΔF of −2N≤ΔF≤2N after heat sterilization. 
     
     
         4 . The composition of  claim 1 , wherein the gel has a Δ Tan δ 1 Hz of less than about 0.1 after heat sterilization. 
     
     
         5 . The composition of  claim 4 , wherein the gel has a Δ Tan δ 1 Hz of less than about -0.03 after storage for 60 days at 45° C. 
     
     
         6 . The composition of  claim 1 , wherein the Vitamin C derivative comprises 3-aminopropyl-L-ascorbylphosphate. 
     
     
         7 . The composition of  claim 6 , wherein the 3-aminopropyl-L-ascorbylphosphate is present at a concentration of about 0.01% w/w to about 2% w/w. 
     
     
         8 . The composition of  claim 7 , wherein the 3-aminopropyl-L-ascorbylphosphate is present at a concentration of about 0.5% w/w to about 0.7% w/w. 
     
     
         9 . The composition of  claim 1 , further comprising lidocaine. 
     
     
         10 . The composition of  claim 9 , wherein the lidocaine is present at a concentration of about 0.05% w/w to about 1% w/w. 
     
     
         11 . The composition of  claim 1 , wherein the pyruvic acid or salt thereof is present at a concentration of about 0.01% w/w to about 2% w/w. 
     
     
         12 . A method of improving thermal stability of a dermal filler product comprising:
 forming a gel comprising a combination of a crosslinked hyaluronic acid or a salt thereof, pyruvic acid or a salt thereof, and Vitamin C or a derivative thereof,   wherein the pyruvic acid or a salt thereof is effective to improve the thermal stability of the gel.   
     
     
         13 . The method of  claim 12 , further comprising heat sterilizing the gel. 
     
     
         14 . The method of  claim 13 , wherein the heat sterilized gel has a ΔF of −2N≤ΔF≤2N after heat sterilization. 
     
     
         15 . The method of  claim 13 , wherein the heat sterilized gel has a Δ Tan δ 1 Hz of less than about 0.1 after heat sterilization. 
     
     
         16 . The method of  claim 12 , wherein the Vitamin C derivative comprises 3-aminopropyl-L-ascorbylphosphate. 
     
     
         17 . The method of  claim 16 , wherein the 3-aminopropyl-L-ascorbylphosphate is present at a concentration of about 0.01% w/w to about 2% w/w. 
     
     
         18 . The method of  claim 17 , wherein the 3-aminopropyl-L-ascorbylphosphate is present at a concentration of about 0.5% w/w to about 0.7% w/w. 
     
     
         19 . The method of  claim 12 , wherein lidocaine is present in the gel at a concentration of about 0.05% w/w to about 1% w/w. 
     
     
         20 . A dermal filler composition comprising crosslinked hyaluronic acid, pyruvic acid or a salt thereof, and Vitamin C or a derivative thereof, wherein the pyruvic acid or salt thereof is present in an amount of about 0.1% w/w to about 1% w/w.