Hyaluronidase enzyme formulations for high volume administration
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.
1 . 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 enzyme comprising a sequence having at least 98% 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
a small molecule active ingredient,
wherein the subcutaneous administration occurs 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.
2 . The method of claim 1 , comprising administering to the subject about 10 mL to about 20 mL of the formulation.
3 . The method of claim 1 , comprising administering to the subject about 3 mL to about 15 mL of the formulation.
4 . The method of claim 1 , wherein the subcutaneous administration occurs via a high volume autoinjector comprising a prefilled syringe containing the formulation.
5 . The method of claim 4 , wherein the prefilled syringe comprises a needle having a gauge of about 20 to about 33.
6 . The method of claim 1 , comprising administering the formulation at a rate of about 0.05 mL/sec to about 1.00 mL/sec.
7 . The method of claim 1 , wherein the formulation has a viscosity of about 1 cP to about 50 cP.
8 . The method of claim 1 , wherein administration of the formulation requires less applied force when compared to a similar formulation that does not comprise a hyaluronidase enzyme.
9 . The method of claim 1 , wherein administration of the formulation is faster when compared to a similar formulation that does not comprise a hyaluronidase enzyme.
10 . The method of claim 1 , wherein administration of the formulation causes fewer side effects, less pain, and less discomfort in the subject when compared to a similar formulation that does not comprise a hyaluronidase enzyme.
11 . The method of claim 1 , wherein administration of the formulation causes less back leakage at the injection site when compared to a similar formulation that does not comprise a hyaluronidase enzyme.
12 . The method of claim 1 , wherein administration of the formulation causes less swelling volume and/or swelling height at the injection site when compared to a similar formulation that does not comprise a hyaluronidase enzyme.
13 . The method of claim 1 , wherein the administering comprises the subject self-administering the formulation.
14 . The method of claim 1 , wherein the small molecule active ingredient is a small molecule antiviral.
15 . The method of claim 1 , wherein the recombinant human hyaluronidase enzyme comprises SEQ ID NO: 2.