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Last Updated: March 28, 2024

Claims for Patent: 8,298,530


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Summary for Patent: 8,298,530
Title:Stable lyophilized pharmaceutical formulation of IgG antibodies
Abstract: This invention is directed to a stable lyophilized pharmaceutical formulation prepared by lyophilizing an aqueous formulation comprising a high concentration, e.g. 50 mg/ml or more, of an IgG antibody in about 5-25 mM histidine buffer having pH from about 5.5 to about 6.5, about 0.005%-0.03% polysorbate, sucrose, and optionally serine, and/or mannitol. This lyophilized formulation is stable at room temperature for at least 6 months, and preferably 1 year. This lyophilized formulation has a short reconstitution time of less than 2 minutes, and is suitable for parenteral administration such as intravenous, intramuscular, intraperitoneal, or subcutaneous injection. This invention is exemplified by the anti-IL2 receptor antibody.
Inventor(s): Kaisheva; Elizabet A. (Belmont, CA), Flores-Nate; Aleni (Union City, CA), Gupta; Supriya (Sunnyvale, CA)
Assignee: Facet Biotech Corporation (Redwood City, CA)
Application Number:12/540,320
Patent Claims:1. A method of reconstituting a lyophilized formulation, comprising adding a diluent to the lyophilized formulation to form a reconstituted solution, wherein the lyophilized formulation was prepared by lyophilizing an aqueous formulation comprising: about 5-25 mM histidine buffer having a pH of from about 5.5 to about 6.5; about 0.005% to about 0.03% polysorbate; about 100-300 mM sucrose; and daclizumab; which lyophilized formulation can, when diluent is added, be reconstituted to a solution containing 50-160 mg/ml daclizumab in a time of less than five minutes.

2. The method of claim 1, wherein the diluent is sterile, pyrogen-free water.

3. The method of claim 1, wherein the reconstituted solution is suitable for subcutaneous injection.

4. The method of claim 1, wherein the reconstituted solution in suitable for intravenous injection.

5. The method of claim 1, wherein the reconstituted solution is isotonic.

6. The method of claim 1, wherein the concentration of daclizumab before lyophilization is greater than 50 mg/ml and the concentration after daclizumab in the reconstituted solution is greater than 50 mg/ml.

7. The method of claim 1, wherein the time to form a particle-free reconstituted solution is less than five minutes.

8. The method of claim 7, wherein the concentration of daclizumab in the reconstituted solution is 160 mg/ml.

9. The method of claim 7, wherein the time to form a particle-free reconstituted solution is two minutes or less.

Details for Patent 8,298,530

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Hoffmann-la Roche Inc. ZENAPAX daclizumab Injection 103749 12/10/1997 ⤷  Try a Trial 2021-07-25
Biogen Inc. ZINBRYTA daclizumab Injection 761029 05/27/2016 ⤷  Try a Trial 2021-07-25
Biogen Inc. ZINBRYTA daclizumab Injection 761029 05/26/2017 ⤷  Try a Trial 2021-07-25
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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