Compositions and methods for treating Gaucher disease
Methods and compositions for treating Gaucher disease are described.
1. A pharmaceutical composition comprising about 2.5 mg/mL of velaglucerase, about 50 mg/mL sucrose, about 12.9 mg/mL sodium citrate dihydrate, about 1.3 mg/mL citric acid monohydrate, and about 0.11 mg/mL polysorbate 20.
2. The composition of claim 1 , wherein the composition is a reconstituted solution.
3. The composition of claim 2 , wherein the composition is reconstituted with sterile water for Injection.
4. A lyophilized pharmaceutical composition comprising velaglucerase, sucrose, sodium citrate dihydrate, citric acid monohydrate, and polysorbate 20, wherein the moisture content of said lyophilized composition is 3% to 5%, and wherein upon reconstitution said lyophilized composition produces a pharmaceutical composition comprising about 2.5 mg/mL of velaglucerase, about 50 mg/mL sucrose, about 12.9 mg/mL sodium citrate dihydrate, about 1.3 mg/mL citric acid monohydrate, and about 0.11 mg/mL polysorbate 20.
5. A method for treating Gaucher disease in a subject in need thereof comprising administering to the subject a therapeutically effective amount of the pharmaceutical composition of claim 1 .