Collagenase formulations and methods of producing the same
Disclosed herein are improved collagenase-containing formulations and methods of preparing the same. The collagenase-containing formulations comprise a collagenase, about 30 mM to about 240 mM of a disaccharide, about 50 mM to about 800 mM of mannitol, and about 6 mM to about 10 mM of a Tris-HCl. Lyophilized and reconstituted formulations are also provided.
1. A formulation comprising:
a collagenase;
about 30 mM to about 240 mM of a disaccharide;
about 50 mM to about 800 mM of mannitol; and
about 6 mM to about 10 mM of Tris-HCl.
2. The formulation of claim 1 , wherein the collagenase is produced by recombinant techniques.
3. The formulation of claim 1 , wherein the disaccharide is sucrose or trehalose.
4. The formulation of claim 1 , wherein the pH of the formulation is about 7.8 to about 8.8.
5. The formulation of claim 1 , wherein the formulation comprises:
a collagenase;
about 60 mM of sucrose;
about 225 mM of mannitol; and
about 10 mM of Tris-HCl,
wherein the formulation has a pH of about 8.5.
6. The formulation of claim 1 , further comprising a surfactant selected from polysorbate 20, polysorbate 80, and poloxamer 188.
7. The formulation of claim 6 , comprising from about 0.01% to about 2% of the surfactant.
8. The formulation of claim 7 , comprising about 0.02% of the surfactant.
9. The formulation of claim 1 , wherein the formulation is liquid.