# US 2014/0194356 A1 · Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein

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- Number: US 2014/0194356 A1
- Document ID: US20140194356A1
- Status: Published application
- Kind: A1
- Application number: 14/234,652
- Filed: 2012-07-25
- Published: 2014-07-10
- Earliest claimed: 2011-07-25
- Assignees: Sandoz Ltd.
- Inventors: Bernt Pragl; Sabine Fuertinger
- Web page: https://patentgrep.com/patent/US20140194356A1

## CPC

- A61K 47/02: Inorganic compounds
- 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 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 38/27: Growth hormone [GH], i.e. somatotropin
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 5/00: Drugs for disorders of the endocrine system
- A61P 13/12: of the kidneys
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/10: for osteoporosis
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- 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

## Abstract

The present invention is related to a pharmaceutically acceptable aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein, wherein the concentration ratio between the biopharmaceutical protein and the neutral salt is in the range of ≧0.7 and ≦5.

## Claims

### Claim 1

A pharmaceutieally acceptable aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein, wherein the concentration ratio between the biopharmaceutical protein and the neutral salt is in the range of ≧0.7 and ≦5.

### Claim 2 (depends on 1)

The formulation according to claim 1, wherein the biopharmaceutical protein has between ≧150 and ≦220 amino acid residues and/or a molecular weight between ≧15 and ≦26 kDaltons.

### Claim 3 (depends on 1)

The formulation according to claim 1, wherein the biopharmaceutical protein is human growth hormone (hGH).

### Claim 4 (depends on 1)

The formulation according to claim 1, wherein said formulation further comprises at least one agent selected from the group consisting of
a buffer,
a non-ionic surfactant,
a tonifier, and/or
a preservative.

### Claim 5 (depends on 4)

The formulation according to claim 4, wherein said buffer is selected from the group consisting of:
Phosphate buffer (Na3PO4, NaH2PO4 and/or Na2HPO4),
Citrate,
Tris,
Succinate,
Acetate, and/or
Histidine.

### Claim 6 (depends on 4)

The formulation according to claim 4, wherein said non-ionic surfactant is selected from the group consisting of:
Poloxamer, preferably Poloxamer 188 or Poloxamer 184,
Pluronic F-68, and/or
Polysorbate, preferably Polysorbate 20 or Polysorbate 80.

### Claim 7 (depends on 4)

The formulation according to claim 4, wherein said tonifier is selected from the group consisting of:
Mannitol,
Glycine, and/or
Sorbitol.

### Claim 8 (depends on 4)

The formulation according to claim 4, wherein said preservative is selected from the group consisting of:
Phenol,
meta-cresol,
methyl paraben,
propyl paraben,
benzalconium chloride,
benzethonium chloride, and/or
Benzyl Alcohol.

### Claim 9 (depends on 3)

The formulation according to claim 3, wherein human growth hormone (hGH) is present in a concentration ranging between ≧3 and ≦20 mg ml−1.

### Claim 10 (depends on 1)

The formulation according to claim 1, wherein said neutral salt is
Sodium Chloride (NaCl).

### Claim 11 (depends on 1)

The formulation according to claim 1, wherein said neutral salt is present in a concentration ranging between ≧2 and ≦100 mg ml−1.

### Claim 12 (depends on 1)

The formulation according to claim 1, wherein the pH of said formulation is in a range between ≧5.8 and ≦6.2

### Claim 13 (depends on 1)

The formulation according to claim 1, wherein said formulation has an optimized stability.

### Claim 14

A method of increasing the stability of a pharmaceutically acceptable aqueous formulation comprising a biopharmaceutical protein, which method comprises providing the biopharmaceutical protein and the neutral salt in a final concentration ration in the range of ≧0.7 and ≦5.

### Claim 15 (depends on 14)

The method of claim 14, wherein the biopharmaceutical protein is human growth hormone (hGH).

### Claim 16 (depends on 14)

Use of a formulation according to claim 14, for the treatment of at least one condition selected from the group consisting of
Growth Hormone Deficiency,
small for gestational age (SGA) or intrauterine growth retardation (IUGR),
Idiopathic Short Stature,
AIDS Wasting and Cachexia,
Short Stature Caused by Turner's Syndrome,
Short Stature Caused by Prader-Willi Syndrome,
Growth Problems Caused by Short Bowel Syndrome,
Improper Growth in Children with Renal Disease,
Rheumatoid Arthritis,
Osteoporosis, and
X-Linked Hypophosphatemic Rickets.

### Claim 17 (depends on 1)

A primary packaging comprising the formulation according to claim 1.