US5278201A
Expired / Lapsed
US
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Biodegradable in-situ forming implants and methods of producing the same
Assignee: Tolmar Therapeutics Inc
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Filing: 1990-04-24
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Granted: 1994-01-11
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Expires: 2010-04-24
Abstract
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.
Inventors
- 👤 Richard L. Dunn
- 👤 James P. English
- 👤 Donald R. Cowsar
- 👤 David P. Vanderbilt
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 10:42
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K9/0024; A61F; A61F2/00; A61K47/00; A61K47/30; A61K47/34; A61L; A61L15/00; A61L15/16; A61L15/42; A61L15/44; A61L15/62; A61L24/00; A61L24/001; A61L24/0015; A61L24/0026; A61L24/0042; A61L24/04; A61L24/046; A61L24/06; A61L26/00; A61L26/0009; A61L26/0019; A61L26/0061; A61L26/0066; A61L26/0076; A61L26/009; A61L27/00; A61L27/14; A61L27/16; A61L27/18; A61L27/26; A61L27/28; A61L27/34; A61L27/50; A61L27/54; A61L27/58; A61F2/02; A61F2/30; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/30062; A61F2002/30316; A61F2002/30535; A61F2002/30581; A61F2002/30583; A61F2210/00; A61F2210/0004; A61F2210/0085; A61L2300/00; A61L2300/20; A61L2300/25; A61L2300/252; A61L2300/40; A61L2300/404; A61L2300/406; A61L2300/41; A61L2300/60; A61L2300/602; A61L2300/604; Y; Y10; Y10S; Y10S525/00; Y10S525/937
Claims Analysis
Total Claims: 25
Claim 1
Independent Claim
76 words
A pharmaceutical composition for forming a solid or coagulated biodegradable implant in-situ within a body, comprising a liquid solution of a non-reactive, biocompatible, pharmaceutically acceptable thermoplastic linear polymer that is water-insoluble and is biodegradable by simple or enzymatically catalyzed hydrolysis, and a pharmaceutically acceptable biocompatible solvent that is water-soluble, wherein the concentrations and formulas of said polymer and said solvent in said solution are effective to form said implant in-situ when said solution contacts body fluid.
Claim 2
Dependent Claim
76 words
A pharmaceutical composition for forming a solid or coagulated biodegradable implant in-situ within a body, comprising a liquid solution of a non-reactive, biocompatible, pharmaceutically acceptable thermoplastic linear polymer that is water-insoluble and is biodegradable by simple or enzymatically catalyzed hydrolysis, and a pharmaceutically acceptable biocompatible solvent that is water-soluble, wherein the concentrations and formulas of said polymer and said solvent in said solution are effective to form said implant in-situ when said solution contacts body fluid.
Claim 3
Dependent Claim
114 words
A pharmaceutical composition for forming a solid or coagulated biodegradable implant in-situ within a body, comprising a liquid solution of a non-reactive, biocompatible, pharmaceutically acceptable, thermoplastic linear polymer that is water-insoluble and a pharmaceutically acceptable biocompatible solvent that is water-soluble, wherein the concentrations and formulas of said polymer and said solvent in said solution are effective to form said implant in situ when said solution contacts body fluid; and wherein said polymer is selected from the group consisting essentially of polylactides, polyglycolides, polycaprolactones, polydioxannones, polycarbonates, polyhydroxybutyrates, polyalkyene oxalates, polyanhydrides, polyamides, polyesteramides, polyurethanes, polyacetals, polyketals, polyorthocarbonates, polyphosphazenes, polyhydroxyvalerates, polyalkylene succinates, poly(malic acid), poly(amino acids), chitin, chitosan, polyorthoesters, and copolymers, terpolymers and combinations and mixtures thereof.
Claim 4
Dependent Claim
114 words
A pharmaceutical composition for forming a solid or coagulated biodegradable implant in-situ within a body, comprising a liquid solution of a non-reactive, biocompatible, pharmaceutically acceptable, thermoplastic linear polymer that is water-insoluble and a pharmaceutically acceptable biocompatible solvent that is water-soluble, wherein the concentrations and formulas of said polymer and said solvent in said solution are effective to form said implant in situ when said solution contacts body fluid; and wherein said polymer is selected from the group consisting essentially of polylactides, polyglycolides, polycaprolactones, polydioxannones, polycarbonates, polyhydroxybutyrates, polyalkyene oxalates, polyanhydrides, polyamides, polyesteramides, polyurethanes, polyacetals, polyketals, polyorthocarbonates, polyphosphazenes, polyhydroxyvalerates, polyalkylene succinates, poly(malic acid), poly(amino acids), chitin, chitosan, polyorthoesters, and copolymers, terpolymers and combinations and mixtures thereof.
Claim 5
Dependent Claim
23 words
The composition of claim 2, wherein said polymer is selected from the group consisting essentially of polylactides, polycaprolactones and copolymers thereof with glycolide.
Claim 6
Dependent Claim
44 words
The composition of claim 2, wherein said solvent is selected from the group consisting essentially of N-methyl-2-pyrrolidone, ethanol, propylene glycol, 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.
Claim 7
Dependent Claim
28 words
The composition of claim 2, wherein said solvent is selected from the group consisting essentially of N-methyl-2-pyrrolidone, 2-pyrrolidone, dimethyl sulfoxide and acetone, and a combination or mixture thereof.
Claim 8
Dependent Claim
16 words
The composition of claim 2, and further comprising an effective amount of a biologically active agent.
Claim 9
Dependent Claim
37 words
The pharmaceutical composition according to claim 2, wherein the concentrations and formulas of said polymer and said solvent are effective to form a space filling implant when said composition is inserted into a site within the body.
Claim 10
Dependent Claim
23 words
The pharmaceutical composition according to claim 3, wherein the weight % of said polymer in said solution is between about 20% and 75%.
Claim 11
Dependent Claim
168 words
A pharmaceutical kit suitable for in situ formation of a biodegradable implant in a body, which comprises: A) a solution of a biodegradable, biocompatible, pharmaceutically acceptable thermoplastic polymer that is water-insoluble and a pharmaceutically acceptable solvent that is water-soluble, wherein the concentrations and formulas of the polymer and the solvent in the solution are effective to form an implant in situ when said solution contacts body fluid and wherein said polymer is selected from the group consisting essentially of polylactides, polyglycolides, polycaprolactones, polydioxannones, polycarbonates, polyhydroxybutyrates, polyalkyene oxalates, polyanhydrides, polyamides, polyesteramides, polyurethanes, polyacetals, polyketals, polyorthocarbonates, polyphosphazenes, polyhydroxyvalerates, polyalkylene succinates, poly(malic acid), poly(amino acids), chitin, chitosan, polyorthoesters, and copolymers, terpolymers and combinations and mixtures thereof; and, B) a device containing said solution, said device having an outlet for the solution, an ejector for expelling the solution through the outlet and a hollow tube fitted to the outlet for inserting the solution into a site of the body such that the solution can form an implant in situ at said site.
Claim 12
Dependent Claim
168 words
A pharmaceutical kit suitable for in situ formation of a biodegradable implant in a body, which comprises: A) a solution of a biodegradable, biocompatible, pharmaceutically acceptable thermoplastic polymer that is water-insoluble and a pharmaceutically acceptable solvent that is water-soluble, wherein the concentrations and formulas of the polymer and the solvent in the solution are effective to form an implant in situ when said solution contacts body fluid and wherein said polymer is selected from the group consisting essentially of polylactides, polyglycolides, polycaprolactones, polydioxannones, polycarbonates, polyhydroxybutyrates, polyalkyene oxalates, polyanhydrides, polyamides, polyesteramides, polyurethanes, polyacetals, polyketals, polyorthocarbonates, polyphosphazenes, polyhydroxyvalerates, polyalkylene succinates, poly(malic acid), poly(amino acids), chitin, chitosan, polyorthoesters, and copolymers, terpolymers and combinations and mixtures thereof; and, B) a device containing said solution, said device having an outlet for the solution, an ejector for expelling the solution through the outlet and a hollow tube fitted to the outlet for inserting the solution into a site of the body such that the solution can form an implant in situ at said site.
Claim 13
Dependent Claim
19 words
The pharmaceutical kit according to claim 9, further comprising a biologically active agent dissolved or dispersed within said solution.
Claim 14
Dependent Claim
39 words
The pharmaceutical kit according to claim 9, wherein said concentrations and formulas of said polymer and said solvent in said solution contained within said device are effective to form an implant in situ when the solution contacts body fluid.
Claim 15
Dependent Claim
35 words
The pharmaceutical kit according to claim 9, wherein said concentrations and formulas of the polymer and the organic solvent are effective to form a space filling implant when the solution is inserted into said site.
Claim 16
Dependent Claim
24 words
The pharmaceutical kit according to claim 9, wherein said polymer is selected from the group consisting of polylactides, polycaprolactones and copolymers thereof with glycolide.
Claim 17
Dependent Claim
44 words
The composition of claim 1, wherein said solvent is selected from the group consisting essentially of N-methyl-2-pyrrolidone, ethanol, propylene glycol, 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.
Claim 18
Dependent Claim
28 words
The composition of claim 1, wherein said solvent is selected from the group consisting essentially of N-methyl-2-pyrrolidone, 2-pyrrolidone, dimethyl sulfoxide and acetone, and a combination or mixture thereof.
Claim 19
Dependent Claim
15 words
The composition of claim 1, further comprising an effective amount of a biologically active agent.
Claim 20
Dependent Claim
37 words
The pharmaceutical composition according to claim 1, wherein the concentrations and formulas of said polymer and said solvent are effective to form a space filling implant when said composition is inserted into a site within the body.
Claim 21
Dependent Claim
128 words
A pharmaceutical kit suitable for in-situ formation of a biodegradable implant in a body, which comprises: A) a solution of a biocompatible, pharmaceutically acceptable thermoplastic polymer that is water-insoluble and is biodegradable by a simple or enzymatically catalyzed hydrolysis, and a pharmaceutically acceptable solvent that is water-soluble, wherein the concentrations and formulas of the polymer and the solvent in the solution are effective to form an implant in-situ when said solution contacts body fluid; and, B) a device containing said solution, said device having an outlet for the solution, an ejector for expelling the solution through the outlet and a hollow tube fitted to the outlet for inserting the solution into a site of the body such that the solution can form an implant in-situ at said site.
Claim 22
Dependent Claim
128 words
A pharmaceutical kit suitable for in-situ formation of a biodegradable implant in a body, which comprises: A) a solution of a biocompatible, pharmaceutically acceptable thermoplastic polymer that is water-insoluble and is biodegradable by a simple or enzymatically catalyzed hydrolysis, and a pharmaceutically acceptable solvent that is water-soluble, wherein the concentrations and formulas of the polymer and the solvent in the solution are effective to form an implant in-situ when said solution contacts body fluid; and, B) a device containing said solution, said device having an outlet for the solution, an ejector for expelling the solution through the outlet and a hollow tube fitted to the outlet for inserting the solution into a site of the body such that the solution can form an implant in-situ at said site.
Claim 23
Dependent Claim
19 words
The pharmaceutical kit according to claim 18, further comprising a biologically active agent dissolved or dispersed within said solution.
Claim 24
Dependent Claim
39 words
The pharmaceutical kit according to claim 18, wherein said concentrations and formulas of said polymer and said solvent in said solution contained within said device are effective to form an implant in situ when the solution contacts body fluid.
Claim 25
Dependent Claim
35 words
The pharmaceutical kit according to claim 18, wherein said concentrations and formulas of the polymer and the organic solvent are effective to form a space filling implant when the solution is inserted into said site.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1997-01-10 | 1997-07-12 | 1998-01-11 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-01-10 | 2001-07-12 | 2002-01-11 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-01-10 | 2005-07-12 | 2006-01-11 | $7700.00 | Window Closed / Lapsed |