Composition for sustained release of human growth hormone
AssigneeAlkermes, Inc.
InventorsOluFunmi Lily Johnson, Medha M. Ganmukhi, Howard Bernstein, Henry Auer, M. Amin Khan
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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.
Claims5
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.
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.
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.
Dependencies are inferred from the claim text.