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US 12,178,860 B2Granted
Hyaluronidase enzyme formulations for high volume administration
AssigneeHalozyme, Inc.
InventorsDavid W. Kang, Robert J. Connor, Tara Nekoroski, Todd J. Leadens, II, Baylor Frantz, Scott Beacher, Kevin Swanson, Mike Travanty
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Abstract
In one aspect, the present disclosure provides a formulation comprising a hyaluronidase enzyme and a therapeutically effective amount of an active ingredient. In another aspect, the present disclosure provides a method of administering a high volume of the formulation in a single administration to treat a disease or disorder in a subject.
Claims12
A method of subcutaneous administration of a hyaluronidase PH20 enzyme formulation to a subject in need thereof,
- the method comprising subcutaneously administering to the subject in need thereof about 3 mL to about 50 mL of a formulation comprising recombinant human hyaluronidase PH20 enzyme comprising a sequence having at least 95% amino acid sequence identity to an amino acid sequence selected from any of SEQ ID NO:
- 1 through 7, and having an activity of about 500 U/mL to about 5,000 U/mL, and an antibody,
- wherein the subcutaneous administration occurs via a high volume autoinjector at a rate of about 0.10 mL/sec to about 1.0 mL/sec and with a starting delivery force of about 3 lbf to about 50 lbf, an ending delivery force of about 5 lbf to about 20 lbf, a starting pressure of about 50 psi to about 200 psi, and/or an ending pressure of about 20 psi to about 75 psi.
Dependencies are inferred from the claim text.