# US 12,178,860 B2 · Hyaluronidase enzyme formulations for high volume administration

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- Number: US 12,178,860 B2
- Document ID: US12178860B2
- Status: Granted
- Kind: B2
- Application number: 18/395,001
- Filed: 2023-12-22
- Published: 2024-06-27
- Granted: 2024-12-31
- Earliest claimed: 2022-12-22
- Assignees: Halozyme, Inc.
- Applicants: Halozyme, Inc.
- Inventors: David W. Kang; Robert J. Connor; Tara Nekoroski; Todd J. Leadens, II; Baylor Frantz; Scott Beacher; Kevin Swanson; Mike Travanty
- Web page: https://patentgrep.com/patent/US12178860B2

## CPC

- A61K 38/47: acting on glycosyl compounds (3.2), e.g. cellulases, lactases
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 9/2474: {Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase}
- C12Y 302/01035: Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- C12Y: ENZYMES

## 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.

## Claims

### Claim 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 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.

### Claim 2 (depends on 1)

The method of claim 1, comprising administering to the subject about 10 mL to about 20 mL of the formulation.

### Claim 3 (depends on 1)

The method of claim 1, comprising administering to the subject about 3 mL to about 15 mL of the formulation.

### Claim 4 (depends on 1)

The method of claim 1, wherein the high volume autoinjector comprises a prefilled syringe containing the formulation.

### Claim 5 (depends on 4)

The method of claim 4, wherein the prefilled syringe comprises a needle having a gauge of about 20 to about 33.

### Claim 6 (depends on 1)

The method of claim 1, wherein the formulation has a viscosity of about 1 cP to about 50 cP.

### Claim 7 (depends on 1)

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.

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 1)

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.

### Claim 12 (depends on 1)

The method of claim 1, wherein the administering comprises the subject self-administering the formulation.