Generated: May 23, 2017
|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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.