FORMULATIONS OF LIQUID STABLE ANTITHROMBIN
In one aspect, the invention provides liquid stable formulations of antithrombin.
1 . A formulation comprising: antithrombin, a buffer, a carboxylic acid, a disaccharide sugar and a salt.
2 . The formulation of claim 1 , wherein the formulation does not include a surfactant.
3 . The formulation of claim 1 , wherein the antithrombin is recombinant human antithrombin (rhAT).
4 . The formulation of claim 1 , wherein the antithrombin has a concentration of 45 to 55 mg/ml.
5 . The formulation of claim 1 , wherein the carboxylic acid is sodium citrate.
6 . The formulation of claim 1 , wherein the carboxylic acid has a concentration of 50 to 600 mM.
7 . The formulation of claim 1 , wherein the buffer is a tris-phosphate buffer.
8 . The formulation of claim 1 , wherein the buffer is between 1 mM and 100 mM.
9 . The formulation of claim 1 , wherein the pH is between 7.5 and 8.5.
10 . The formulation of claim 1 , wherein the disaccharide sugar is sucrose.
11 . The formulation of claim 1 , wherein the disaccharide sugar is 0.5 to 5% of volume by weight.
12 . The formulation of claim 1 , wherein the salt is sodium chloride.
13 . The formulation of claim 1 , wherein the salt has a concentration of between 25 mM and 100 mM.
14 . The formulation of claim 1 , wherein the antithrombin has a concentration of 50 mg/ml, wherein the carboxylic acid is sodium citrate and has a concentration of 300 mM, wherein the disaccharide sugar is sucrose and is 1% of volume by weight, wherein the salt is sodium chloride and has a concentration of 50 mM.
15 . The formulation of claim 14 , wherein the antithrombin is antithrombin alfa.
16 . The formulation of claim 14 , wherein the buffer is 10 mM tris-phosphate and the pH is 8.