Composition for sustained release of human growth hormone

• US 5,667,808 A
• Filed: 06/07/1995
• Issued: 09/16/1997
• Est. Priority Date: 12/02/1992
• Status: Expired due to Fees

• Current Assignee: Alkermes Controlled Therapeutics Inc. II (Alkermes plc)
• Original Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Inventors: Bernstein, Howard, Khan, M. Amin, Johnson, OluFunmi Lily, Ganmukhi, Medha M., Auer, Henry
• Primary Examiner(s): Azpuru, Carlos A.
• Application Number:
  US08/477,725
• Time in Patent Office: 832 Days
• Field of Search: 424/426, 424/501, 424/502, 514/772.3, 428/402.21, 264/4.6
• US Class Current: 424/501
• CPC Class Codes: A61K 38/27 Growth hormone [GH], i.e. somatotropin
• CPC Class Codes: A61K 9/1611 Inorganic compounds
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/1694 resulting in granules or microspheres of the matrix type containing more than 5% of excipient
• CPC Class Codes: B82Y 5/00 Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
• CPC Class Codes: Y10S 530/839 Nerves; brain
• CPC Class Codes: Y10T 428/2985 Solid-walled microcapsule from synthetic polymer

Abstract

The method of using the sustained release composition of the present invention comprises providing a therapeutically effective blood level of biologically active, non-aggregated human growth hormone in a subject for a sustained period by administering to the subject a dose of said sustained release composition.

Claims

1. A method for forming a metal cation-complexed human growth hormone, comprising the steps of:

a) forming a solution containing human growth hormone;

b) dispersing a multivalent metal cation component with the human growth hormone solution under pH conditions suitable for complexing the multivalent metal cation with the human growth hormone, thereby forming a metal cation-complexed human growth hormone suspension wherein the molar ratio of metal cation component to hGH is between about 4;

1 to about 100;

1; and

c) drying said suspension to form the metal cation-complexed human growth hormone.

2. A method of claim 1 wherein the molar ratio of metal cation component to hGH is between about 6:

1 to about 10;

1.

3. A method of claim 1 wherein the hGH solution is in a sodium bicarbonate buffer.

4. A method for forming a zinc-complexed human growth hormone, comprising the steps of:

a) forming a solution containing human growth hormone;

b) dispersing zinc acetate within the human growth hormone solution under pH conditions suitable for complexing zinc with the human growth hormone, thereby forming a zinc-complexed human growth hormone suspension wherein the molar ratio of metal cation component to hGH is between about 4;

1 to about 100;

1; and

c) drying said suspension to form the zinc-complexed human growth hormone.

5. A method for forming a metal cation-complexed human growth hormone, comprising the steps of:

a) forming a solution containing human growth hormone;

b) dispersing a multivalent metal cation component within the human growth hormone solution at a pH in the range of between about 7.0 and about 7.4, thereby forming a metal cation-complexed human growth hormone suspension wherein the molar ratio of metal cation component to hGH is between about 4;

1 to about 100;

1; and

c) drying said suspension to form the metal cation-complexed human growth hormone.