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Claims for Patent: 5,912,015

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Claims for Patent: 5,912,015

Title: Modulated release from biocompatible polymers
Abstract:The present invention relates to a composition for the modulated release of a biologically active agent. The composition comprises a biocompatible polymeric matrix, a biologically active agent which is dispersed within the polymeric matrix, and a metal cation component which is separately dispersed within the polymeric matrix, whereby the metal cation component modulates the release of the biologically active agent from the polymeric matrix. The present invention also relates to a method for modulating the release of a biologically active agent from a biocompatible polymeric matrix, comprising the steps of dissolving a biocompatible polymer in a solvent to form a polymer solution and also separately dispersing a metal cation component and a biologically active agent within the polymer solution. The polymer solution is then solidified to form a polymeric matrix, wherein at least a significant portion of the metal cation component is dispersed in the polymeric matrix separately from the biologically active protein, and whereby the metal cation component modulates the release of the biologically active agent from the polymeric matrix.
Inventor(s): Bernstein; Howard (Cambridge, MA), Zhang; Yan (Belmont, CA), Khan; M. Amin (Carmel, IN), Tracy; Mark A. (Arlington, MA)
Assignee: Alkermes Controlled Therapeutics, Inc. (Cambridge, MA)
Application Number:09/056,566
Patent Claims: 1. A method of delivering a biologically active agent to an individual in need thereof comprising the step of administering to said patient a composition for the modulated release of a biologically active agent comprising:

a) a biocompatible polymer matrix;

b) an effective amount of a biologically active agent, wherein the biologically active agent is dispersed within the polymer matrix; and

c) one or more metal cation components for modulating release of the biologically active agent from the polymer matrix wherein the metal cation component comprises a cation selected from the group consisting of Zn(II), Mg(II) and a combination of at least two different multivalent metal cations, and wherein the metal cation component is separately dispersed within the polymer matrix.

2. The method of claim 1 wherein said metal cation component is selected from the group consisting of magnesium hydroxide, magnesium carbonate, zinc carbonate, magnesium acetate, zinc acetate, magnesium chloride, zinc chloride, magnesium sulfate, zinc sulfate, magnesium citrate and zinc citrate.

3. The method of claim 1 wherein said polymer is a biodegradable polymer.

4. The method of claim 3 wherein said biodegradable polymer is selected from the group consisting of poly(lactide)s, poly(glycolide)s, poly(lactide-co-glycolide)s, poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polyanhydrides, polyorthoesters, polyetheresters, polycaprolactone, polyesteramides, blends and copolymers thereof.

5. The method of claim 1 wherein said biologically active agent is a protein selected from the group consisting of nucleases, erythropoietin, human growth hormone, interferons, interleukins, growth factors, tumor necrosis factor, adrenocorticotropic hormone, and colony-stimulating factors.

6. A method of delivering a biologically active agent to an individual in need thereof comprising the step of administering to said patient a composition for the modulated release of a biologically active agent comprising:

a) a biocompatible polymer matrix of a poly(lactide-co-glycolide) polymer;

b) an effective amount of a biologically active agent, wherein said biologically active agent is dispersed within the polymer matrix; and

c) one or more metal cation components for modulating release of the biologically active agent from the polymer matrix, wherein the metal cation component comprises a cation selected from the group consisting of Zn(II), Mg(II)and a combination of at least two different multivalent metal cations and wherein the metal cation component is separately dispersed within the polymer matrix.

7. The method of claim 6 wherein said metal cation component is selected from the group consisting of magnesium hydroxide, magnesium carbonate, zinc carbonate, magnesium acetate, zinc acetate, magnesium sulfate, zinc sulfate, magnesium chloride, zinc chloride, zinc citrate, magnesium citrate and a combination thereof.

8. The method of claim 6 wherein said biologically active agent is a protein selected from the group consisting of nucleases, erythropoietin, human growth hormone, interferons, interleukins, growth factors, tumor necrosis factor, adrenocorticotropic hormone and colony-stimulating factors.
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