# US 12,594,337 B2 · Human serum albumin in formulations

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- Number: US 12,594,337 B2
- Document ID: US12594337B2
- Status: Granted
- Kind: B2
- Application number: 17/566,234
- Filed: 2021-12-30
- Published: 2022-04-21
- Granted: 2026-04-07
- Earliest claimed: 2019-03-05
- Assignees: Regeneron Pharmaceuticals, Inc.
- Applicants: Regeneron Pharmaceuticals, Inc.
- Inventors: Dorothy Kim; Michael Marlow
- Web page: https://patentgrep.com/patent/US12594337B2

## CPC

- 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 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34)
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- 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)

## Abstract

Drug formulations and methods for removing, reducing, or preventing the formation of fatty acid particles in drug formulations are provided. In particular, this disclosure sets forth the inclusion of human serum albumin in an active pharmaceutical agent formulation, such as an antibody drug formulation, at an effective concentration for reducing fatty acid particle formation and solubilizing fatty acid particles.

## Claims

### Claim 1

A formulation, comprising:
an active pharmaceutical agent, a polysorbate, at least one lipase, and at least about 5.5 mg/mL human serum albumin, wherein said formulation is capable of forming fatty acid particles, wherein said human serum albumin reduces said formation of fatty acid particles, and wherein said active pharmaceutical agent is not human serum albumin.

### Claim 2 (depends on 1)

The formulation of claim 1, wherein the active pharmaceutical agent comprises a monoclonal antibody.

### Claim 3 (depends on 1)

The formulation of claim 1, wherein the active pharmaceutical agent comprises a polyclonal antibody.

### Claim 4 (depends on 1)

The formulation of claim 1, wherein the active pharmaceutical agent comprises a therapeutic antibody.

### Claim 5 (depends on 1)

The formulation of claim 1, wherein the polysorbate is selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, or combination thereof.

### Claim 6 (depends on 1)

The formulation of claim 1, wherein the formulation is a parenteral formulation.

### Claim 7 (depends on 1)

The formulation of claim 1, wherein said fatty acid particles are formed by degradation of said polysorbate.

### Claim 8 (depends on 7)

The formulation of claim 7, wherein the fatty acid particles comprise a free fatty acid.

### Claim 9 (depends on 8)

The formulation of claim 8, wherein the free fatty acid is an aliphatic acid with about six to about twenty-two carbons.

### Claim 10 (depends on 8)

The formulation of claim 8, wherein the free fatty acid is oleic acid.

### Claim 11 (depends on 8)

The formulation of claim 8, wherein the free fatty acid is selected from the group consisting of oleic acid, palmitic acid, stearic acid, myristic acid, lauric acid, and combinations thereof.

### Claim 12 (depends on 8)

The formulation of claim 8, wherein a ratio of molecules of the free fatty acid to molecules of the human serum albumin in the formulation is about 6:1 to about 1:1.

### Claim 13 (depends on 1)

The formulation of claim 1, wherein the concentration of the polysorbate in the formulation is about 0.001% w/v to 1% w/v.

### Claim 14 (depends on 1)

The formulation of claim 1, wherein the human serum albumin is fatty acid-free human serum albumin.