# US 5,705,482 A · Pharmaceutical formulation

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 5,705,482 A
- Document ID: US5705482A
- Status: Granted
- Kind: A
- Application number: 08/372,635
- Filed: 1995-01-13
- Granted: 1998-01-06
- Earliest claimed: 1995-01-13
- Assignees: Novo Nordisk A/S
- Inventors: Thorkild Christensen; Per Balschmidt; Hans Holmegaard S.o slashed.rensen; Ole Hvilsted Olsen; Lars Thim
- Web page: https://patentgrep.com/patent/US5705482A

## CPC

- A61K 38/27: Growth hormone [GH], i.e. somatotropin
- 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

A pharmaceutical formulation comprising a growth hormone and Leu-His-Leu as additive or buffering substance shows a very high stability against deamidation, oxidation and cleavage of peptide bonds. The stability of the product allows for the storing and shipment thereof in a lyophilized state or in the form of a dissolved or re-dissolved formulation at ambient temperature.

## Claims

### Claim 1

A pharmaceutical formulation comprising hGH and Leu-His-Leu.

### Claim 2 (depends on 1)

A pharmaceutical formulation as claimed in claim 1 in which said formulation is in the form of a buffered aqueous solution.

### Claim 3 (depends on 1)

A pharmaceutical formulation as claimed in claim 1 wherein the pH is adjusted to a value in the interval from about 5 to about 7.

### Claim 4 (depends on 1)

A pharmaceutical formulation as claimed in claim 1 wherein the concentration of Leu-His-Leu is up to about 100 mM.

### Claim 5 (depends on 1)

A pharmaceutical formulation as claimed in claim 1 further comprising salts and saccharides.

### Claim 6 (depends on 1)

A method of preparing the pharmaceutical formulation of claim 1 comprising adding the growth hormone to a solution comprising Leu-His-Leu.

### Claim 7 (depends on 6)

The method according to claim 6 which the solution comprising Lys-X is obtained by dissolving Leu-His-Leu in aleionized water.

### Claim 8 (depends on 6)

The method acocrding to claim 6 in which the solution comprising Leu-His-Leu also comprises benzyl alcohol.

### Claim 9 (depends on 6)

The method according to claim 6 which further comprises adjusting the pH of said formulation for from aobut 5 to about 7.

### Claim 10 (depends on 6)

The method according to claim 6 which further comprises adding an excipient.

### Claim 11 (depends on 6)

The method according to claim 6 which further comprises filling a solution comprising growth hormone and Leu-His-Leu into a container and lyophilizing said solution.

### Claim 12 (depends on 1)

A method for treating a disorder in a patient affectable by growth hormone comprising treating the patient with an amount of the pharmaceutical formulation of claim 1 effective to treat said disorder.