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Claims for Patent: RE37950

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Claims for Patent: RE37950

Title: Biogradable in-situ forming implants and methods of producing the same
Abstract:A biodegradable polymer is provided for use in providing syringeable, in-situ forming, solid biodegradable implants for animals. The polymer is placed into the animal in liquid form and cures to form the implant in-situ. A thermoplastic system to form said implant comprises the steps of dissolving a non-reactive polymer in biocompatible solvent to form a liquid, placing the liquid within the animal, and allowing the solvent to dissipate to produce the implant. An alternative, thermosetting system comprises mixing together effective amounts of a liquid acrylic ester terminated, biodegradable prepolymer and a curing agent, placing the liquid mixture within an animal and allowing the prepolymer to cure to form the implant. Both systems provide a syringeable, solid biodegradable delivery system by the addition of an effective level of biologically active agent to the liquid before injection into the body.
Inventor(s): Dunn; Richard L. (Fort Collins, CO), English; James P. (Chelsea, AL), Cowsar; Donald R. (Savannah, GA), Vanderbilt; David P. (St. Louis, MO)
Assignee: Atrix Laboratories (Fort Collins, CO)
Application Number:09/536,579
Patent Claims: 1. A method of forming a solid, biodegradable implant in-situ in a body, comprising: (a) dissolving a .Iadd.solid, .Iaddend.water-insoluble, biodegradable, .Iadd.linear .Iaddend.thermoplastic polymer in a biocompatible, water-soluble organic solvent to form a flowable composition; the organic solvent being capable of dissolving the thermoplastic polymer and being capable of dissipating or diffusing into a body fluid upon placement within a body; and (b) placing the composition into an implant site within the body; and (c) allowing the organic solvent to dissipate or diffuse into body fluid, and the thermoplastic polymer to coagulate or solidify to produce the biodegradable solid implant, wherein the proportion of polymer in solvent and the polymer molecular weight are effective to provide said dissipating or diffusing function and said coagulating or solidifying function.

2. The method of claim 1, wherein the .Iadd.solid, linear .Iaddend.thermoplastic polymer is selected from the group consisting of polylactides, polyglycolides, polycaprolactones, polydioxanones, polycarbonates, polyhydroxybutyrates, polyalkylene oxalates, polyanhydrides, polyamides, polyesteramides, .[.polyacetates.]. .Iadd.polyacetals.Iaddend., polyketals, polyorthocarbonates, polyphosphazenes, polyhydroxyvalerates, polyalkylene succinates, poly(amino acids), polyorthoesters, and copolymers, terpolymers, or combinations and mixtures thereof.Iadd., .Iaddend.each named thermoplastic polymer, copolymer, terpolymer, combination or mixture being biodegradable.

3. The method of claim 1, wherein the .Iadd.solid, linear thermoplastic .Iaddend.polymer is selected from the group consisting of polylactides, polyglycolides, polycaprolactones, and copolymers thereof.

4. The method of claim 1, wherein the organic solvent is selected from the group consisting of N-methyl-2-pyrrolidone, 2-pyrrolidone, acetone, methyl acetate, ethyl acetate, methyl ethyl ketone, dimethylformamide, dimethyl sulfoxide, tetrahydrofuran, caprolactam, decylmethylsulfoxide, oleic acid, and 1-dodecylazacycloheptan-2-one, and combinations and mixtures thereof.

5. The method of claim 1, further comprising combining a biologically-active agent with the .Iadd.solid, linear .Iaddend.thermoplastic polymer and organic solvent.

6. A pharmaceutical composition for forming a solid biodegradable implant in situ within a body, comprising: an effective amount of a .Iadd.solid, .Iaddend.water-insoluble, biodegradable, .Iadd.linear .Iaddend.thermoplastic polymer dissolved in an effective amount of a biocompatible, water-soluble organic solvent, wherein the solvent is capable of dissolving the thermoplastic polymer and is capable of dissipating or diffusing into a body fluid and the polymer is capable of coagulating or solidifying upon contact with body fluid; and wherein the pharmaceutical composition has a flowable consistency and the molecular weight of the polymer, the amounts of the polymer and the solvent in the pharmaceutical composition are effective to form the solid implant in situ when the pharmaceutical composition contacts body fluid.

7. The pharmaceutical composition of claim 6, wherein the .Iadd.solid, linear .Iaddend.thermoplastic polymer is selected from the group consisting of: polylactides, polyglycolides, polycaprolactones, polydioxanones, polycarbonates, polyhydroxybutyrates, polyalkylene oxalates, polyanhydrides, polyamides, polyesteramides, .[.polyacetates.]. .Iadd.polyacetals.Iaddend., polyketals, polyorthocarbonates, polyphosphazenes, polyhydroxyvalerates., polyalkylene succinates, poly(amino acids), polyorthoesters, and copolymers, terpolymers, or combinations and mixtures thereof each named thermoplastic polymer, copolymer, terpolymer, combination and mixture being biodegradable.

8. The pharmaceutical composition of claim 6, wherein the .Iadd.solid, linear .Iaddend.thermoplastic polymer is selected from the group consisting of: polylactides, polyglycolides, polycaprolactones, and copolymers thereof.

9. The pharmaceutical composition of claim 6, wherein the organic solvent is selected from the group consisting of: N-methyl-2-pyrrolidone, 2-pyrrolidone, acetone, methyl acetate, ethyl acetate, methyl ethyl ketone, dimethylformamide, dimethyl sulfoxide, tetrahydrofuran, caprolactam, decylmethylsulfoxide, oleic acid and 1-dodecylazacycloheptan-2-one, and combinations and mixtures thereof.

10. The pharmaceutical composition of claim 6, further comprising a biologically-active agent combined with the .Iadd.solid, linear .Iaddend.thermoplastic polymer and organic solvent.

11. The pharmaceutical composition of claim 10, wherein the biologically-active agent is an antibiotic, antimicrobial, peptide drug, protein drug, or a combination thereof.

12. The pharmaceutical composition of claim 10, wherein the biologically-active agent is a tetracycline.

13. The pharmaceutical composition of claim 10, wherein the composition is a homogenous solution, a suspension, or a dispersion.

14. A method of delivering a biologically-active agent to .[.an animal.]. .Iadd.a living body .Iaddend.comprising: administering a pharmaceutical composition according to claim 10 to the .[.animal.]. .Iadd.living body.Iaddend., wherein the pharmaceutical composition forms a solid implant and the biologically-active agent is released from the implant into the .[.animal.]. .Iadd.living body.Iaddend.. .Iadd.

15. An in situ formed biodegradable implant comprising a mixture of a water-insoluble, biodegradable, solid, linear thermoplastic polymer, a biologically active agent and a water-soluble, biocompatible organic solvent, wherein the implant is surrounded by a body tissue, at least some of the polymer is solidified and the remainder of the polymer is in solution with the solvent..Iaddend..Iadd.

16. An implant according to claim 15 wherein the organic solvent has a water solubility, a biocompatibility and a thermoplastic polymer dissolubility exemplified by a compound selected from the group consisting of N-methyl pyrrolidone, 2-pyrrolidone, ethanol, propylene glycol, acetone, methyl acetate, ethyl acetate, methyl ethyl ketone, dimethylformamide, dimethyl sulfoxide, tetrahydrofuran, caprolactam, decylmethyl sulfoxide, oleic acid and 1-dodecylazacycloheptan-2-one..Iaddend..Iadd.

17. An implant according to claim 16 wherein the compound is N-methyl pyrrolidone or dimethyl sulfoxide..Iaddend..Iadd.

18. An implant according to claim 16 wherein the compound is ethyl acetate or oleic acid of 1-dodecylazacycloheptan-2-one..Iaddend..Iadd.

19. An implant according to claim 15 wherein essentially all of the solid, linear thermoplastic polymer is solidified..Iaddend..Iadd.

20. An implant according to claim 19, wherein at least some organic solvent is present in the implant..Iaddend..Iadd.

21. An implant according to claim 19 wherein essentially no organic solvent is present in the implant..Iaddend..Iadd.

22. An implant according to claim 15 wherein the biodegradable, solid, linear thermoplastic polymer is selected from the group consisting of polylactides, polyglycolides, polycaprolactones, polydioxanones, polycarbonates, polyhydroxybutyrates, polyalkyleneoxalates, polyanhydrides, polyamides, polyesteramides, polyacetals, polyketals, polyorthocarbonates, polyphosphazenes, polyhydroxyvalerates, polyalkylenesuccinates, poly(amino acids), polyorthoesters, and copolymers, terpolymers, combinations and mixtures thereof..Iaddend..Iadd.

23. An implant according to claim 22 wherein the linear, solid, thermoplastic polymer is a homopolymer or copolymer of lactide, glycolide, caprolactone or a combination thereof..Iaddend..Iadd.

24. An implant according to claim 15 that is elastomeric..Iaddend..Iadd.

25. An implant according to claim 15 that has a rigidity like that of hard tissue..Iaddend..Iadd.

26. An implant according to claim 15 that is a coagulate..Iaddend..Iadd.

27. An implant according to claim 15 that is a solid..Iaddend..Iadd.

28. An implant according to claim 15 wherein the biologically active agent is an antibiotic, antimicrobial, peptide drug, protein drug, or a combination thereof..Iaddend..Iadd.

29. And implant according to claim 15 wherein the biologically active agent is a peptide drug..Iaddend..Iadd.

30. An implant according to claim 26 that has fully coagulated..Iaddend..Iadd.

31. An implant according to claim 27 that has fully solidified..Iaddend..Iadd.

32. An implant according to claim 15 wherein essentially all of the solid, linear, thermoplastic polymer is a solid and is elastomeric..Iaddend..Iadd.

33. An implant according to claim 15 wherein essentially all of the solid, linear, thermoplastic polymer is a solid and is usable with hard tissue..Iaddend..Iadd.

34. An in situ formed biodegradable implant comprising a mixture of a water insoluble, biodegradable, solid, linear thermoplastic polymer, and a water-soluble, biocompatible organic solvent, wherein the implant is surrounded by a body tissue, at least some of the polymer is solidified, and the remainder of the polymer is in solution with the solvent..Iaddend..Iadd.

35. An in situ formed biodegradable implant comprising a mixture of a water insoluble, biodegradable, solid, linear thermoplastic polymer, and a biologically active agent, wherein the implant is surrounded by a body tissue and the polymer is a solid..Iaddend..Iadd.

36. An in situ formed biodegradable implant comprising a mixture of a water insoluble, biodegradable, solid, linear thermoplastic polymer, and a biologically active agent, wherein the implant is surrounded by a body tissue and the polymer is a solid..Iaddend.
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