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|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|
|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.