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Details for Patent: 5,667,808

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Details for Patent: 5,667,808

Title: Composition for sustained release of human growth hormone
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.
Inventor(s): Johnson; OluFunmi Lily (Cambridge, MA), Ganmukhi; Medha M. (Wexford, PA), Bernstein; Howard (Cambridge, MA), Auer; Henry (Belmont, MA), Khan; M. Amin (Dowington, PA)
Assignee: Alkermes, Inc. (Cambridge, MA)
Filing Date:Jun 07, 1995
Application Number:08/477,725
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.
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