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.
Claims20
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 about 3 mL to about 50 mL of a formulation comprising recombinant human hyaluronidase PH20 enzyme comprising a sequence having at least 98% amino acid sequence identity to an amino acid sequence comprising SEQ ID NO:
- 15, and having an activity of about 500 U/mL to about 5,000 U/mL,
- wherein the subcutaneous administration occurs at a rate of about 0.10 mL/sec to about 1.0 mL/sec.
A method of reducing one or more side effects of a high-volume subcutaneous injection in a subject in need thereof,
- the method comprising subcutaneously administering to the subject about 3 mL to about 50 mL of a formulation comprising recombinant human hyaluronidase PH20 enzyme comprising a sequence having at least 98% amino acid sequence identity to an amino acid sequence comprising SEQ ID NO:
- 15, and having an activity of about 500 U/mL to about 5,000 U/mL, and an active ingredient selected from a small molecule, a peptide, a nanoparticle, an antibody, and an antibody fragment,
- wherein the subcutaneous administration occurs at a rate of about 0.10 mL/sec to about 1.0 mL/sec and the one or more side effects are selected from pain and discomfort at the injection site, back leakage at the injection site, swelling at the injection site, bleb swelling, and bleb induration.
Dependencies are inferred from the claim text.