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Details for Patent: 5,891,478

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Details for Patent: 5,891,478

Title: Composition for sustained release of human growth hormone
Abstract:The method of the invention for producing a composition for the sustained release of biologically active hGH includes dissolving a biocompatible polymer in a polymer solvent to form a polymer solution, dispersing particles of biologically active, metal cation-stabilized hGH in the polymer solution, and then solidifying the polymer to form a polymeric matrix containing a dispersion of said hGH particles.
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 Controlled Therapeutics, Inc. (Cambridge, MA)
Filing Date:Mar 02, 1998
Application Number:
Claims:1. A method of forming a composition for the sustained release of human growth hormone from a polymeric matrix comprising the steps of:

a) forming a mixture comprising a biocompatible polymer, particles of metal cation-complexed hGH and a polymer solvent; and

b) solidifying the mixture to form a polymeric matrix containing a dispersion of said hGH particles.

2. The method of claim 1 wherein step (a) further comprises the steps of:

(i) forming droplets of the mixture; and

(ii) freezing the droplets of step (i), prior to the solidifying of step (b).

3. The method of claim 2 wherein the polymer is solidified by removing the polymer solvent by extraction with a polymer non-solvent.

4. The method of claim 1 wherein the biocompatible polymer is selected from the group consisting of:

poly(lactides), poly(glycolides), poly(lactide-co-glycolides), poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acids)s, polycaprolactones, polycarbonates, polyesteramides, polyanhydrides, poly(amino acids), polyorthoesters, polycyanoacrylates, poly(p-dioxanone)s, poly(alkylene oxalate)s, biodegradable polyurethanes, blends and copolymers thereof.

5. The method of claim 4 wherein the biocompatible polymer is poly(lactide-co-glycolide).

6. The method of claim 1 wherein the metal cation-complexed human growth hormone contains a multivalent metal cation component.

7. The method of claim 6 wherein the multivalent metal cation component is zinc.

8. The method of claim 7 wherein the particles of hGH have a zinc to hGH molar ratio between 4:1 and 100:1.

9. The method of claim 1 further comprising the step of dispersing a second metal cation component in the mixture wherein the second metal cation is not complexed to said human growth hormone.

10. The method of claim 9 wherein the second metal cation component is zinc carbonate.

11. The method of claim 1 wherein the polymeric matrix is in the form of microparticles.

12. The method of claim 1 wherein the final proportion of human growth hormone in the sustained release composition is between 10 and 30 weight percent.
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