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US 5,681,873 AGranted
Biodegradable polymeric composition
AssigneeAtrix Laboratories, Inc.
InventorsRichard L. Norton, Stephen Michael Gregory Knight, Arthur J. Tipton
Life of this patent
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Abstract
The invention provides moldable, biodegradable composition for use with bone and other tissues. The composition comprises a poly(caprolactone) thermoplastic polymer processed alone or compounded with a biocompatible, biodegradable substance that controls crystallization of the polymer and functions to soften the composition. The composition may further include a biologically-active agent such as an antibiotic for sustained delivery in an animal, a coloring agent for tinting the composition, and other additives as desired.
Claims17
A biodegradable, pharmaceutical composition, consisting of:
- (a) a biodegradable poly(caprolactone) thermoplastic polymer having a weight average molecular weight of about 600-3000;
- and
- (b) a biodegradable, crystallization-controlling agent selected from the group consisting of calcium carbonate, hydroxyapatite, calcium phosphate, calcium apatite, calcium sulfate, calcium bicarbonate, calcium chloride, sodium carbonate, sodium bicarbonate, sodium chloride, calcium stearate, calcium palmitate, sodium stearate, dextran, starch, sodium carboxymethyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, poly(vinyl alcohol), glycerol palmitate, glycerol stearate, triethyl citrate, ethyl lactate, poly(ethylene glycol), poly(vinyl pyrrolidone), poly(lactide-co-caprolactone), and combinations thereof;
- wherein the composition contains the crystallization-controlling agent in an amount effective to maintain the poly(caprolactone) as a moldable mass wherein crystalline regions of the poly(caprolactone) polymer are substantially uniformly distributed throughout;
- and the composition has a spreadable consistency and is capable of adhering to and providing an effective amount of homeostasis in a bone defect.
2 more elements
A biodegradable, pharmaceutical composition, consisting of:
- (a) a biodegradable poly(caprolactone) thermoplastic polymer having a weight average molecular weight of about 600-3000;
- (b) a biodegradable, crystallization-controlling agent selected from the group consisting of calcium carbonate, hydroxyapatite, calcium phosphate, calcium apatite, calcium sulfate, calcium bicarbonate, calcium chloride, sodium carbonate, sodium bicarbonate, sodium chloride, calcium stearate, calcium palmitate, sodium stearate, dextran, starch, sodium carboxymethyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, poly(vinyl alcohol), glycerol palmitate, glycerol stearate, triethyl citrate, ethyl lactate, poly(ethylene glycol), poly(vinyl pyrrolidone), poly(lactide-co-caprolactone), and combinations thereof;
- and
- (c) one or more additives selected from the group consisting of a biologically-active agent, a coloring agent, a release rate modification agent, and a pore forming agent;
- wherein the composition contains the crystallization-controlling agent in an amount effective to maintain the poly(caprolactone) as a moldable mass wherein crystalline regions of the poly(caprolactone) polymer are substantially uniformly distributed throughout;
- and the composition has a spreadable consistency and is capable of adhering to and providing an effective amount of homeostasis in a bone defect.
3 more elements
A biodegradable, pharmaceutical composition, produced by the process of:
- (a) combining a biodegradable poly(caprolactone) thermoplastic polymer with a biodegradable crystallization-controlling agent to form a mixture;
- the polymer having a weight average molecular weight of about 600-3000;
- and the crystallization-controlling agent selected from the group consisting of calcium carbonate, hydroxyapatite, calcium phosphate, calcium apatite, calcium sulfate, calcium bicarbonate, calcium chloride, sodium carbonate, sodium bicarbonate, sodium chloride, calcium stearate, calcium palmitate, sodium stearate, dextran, starch, sodium carboxymethyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, poly(ethylene glycol), poly(vinyl pyrrolidone), poly(lactide-co-caprolactone), and combinations thereof;
- (b) melting the polymer mixture to a molten mass;
- and
- (c) cooling the polymer mixture at a temperature of about 30.degree.-50.degree. C. and over a time period of about 1-72 hours to form the biodegradable composition;
- wherein the composition contains the crystallization-controlling agent in an amount effective to maintain the poly(caprolactone) as a moldable mass wherein crystalline regions of the poly(caprolactone) polymer are substantially uniformly distributed throughout and the composition has a spreadable consistency and is capable of adhering to and providing and effective amount of homeostasis in a bone defect.
4 more elements
A method for treating a tissue defect, comprising:
- applying an effective amount of a biologically-acceptable, biodegradable composition to the defect, the composition consisting of:
- a biodegradable poly(caprolactone) thermoplastic polymer having a weight average molecular weight of about 600-3000, and a biodegradable, crystallization-controlling agent selected from the group consisting of calcium carbonate, hydroxyapatite, calcium phosphate, calcium apatite, calcium sulfate, calcium bicarbonate, calcium chloride, sodium carbonate, sodium bicarbonate, sodium chloride, calcium stearate, calcium palmitate, sodium stearate, dextran, starch, sodium carboxymethyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, poly(vinyl alcohol), glycerol palmitate, glycerol stearate, triethyl citrate, ethyl lactate, poly(ethylene glycol), poly(vinyl pyrrolidone), poly(lactide-co-caprolactone), and combinations thereof;
- the composition being a moldable mass wherein crystalline regions of the poly(caprolactone) polymer are substantially uniformly distributed throughout;
- wherein the composition provides an effective amount of hemostasis in the defect, promotes tissue regrowth in the defect, or a combination thereof.
1 more element
A method for treating a tissue defect, comprising:
- applying an effective amount of a biologically-acceptable, biodegradable composition to the defect, the composition consisting of:
- a biodegradable poly(caprolactone) thermoplastic polymer having a weight average molecular weight of about 600-3000;
- a biodegradable, crystallization-controlling agent selected from the group consisting of calcium carbonate, hydroxyapatite, calcium phosphate, calcium apatite, calcium sulfate, calcium bicarbonate, calcium chloride, sodium carbonate, sodium bicarbonate, sodium chloride, calcium stearate, calcium palmitate, sodium stearate, dextran, starch, sodium carboxymethyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, poly(vinyl alcohol), glycerol palmitate, glycerol stearate, triethyl citrate, ethyl lactate, poly(ethylene glycol), poly(vinyl pyrrolidone), poly(lactide-co-caprolactone), and combinations thereof;
- and
- an effective amount of a biologically active agent;
- the composition being a moldable mass wherein crystalline regions of the poly(caprolactone) polymer are substantially uniformly distributed throughout;
- wherein the composition provides an effective amount of hemostasis in the defect, promotes tissue regrowth in the defect, or a combination thereof.
4 more elements
A method for treating a tissue defect, comprising:
- applying an effective amount of a biologically-acceptable, biodegradable composition to the defect, the composition consisting of:
- a biodegradable poly(caprolactone) thermoplastic polymer having a weight average molecular weight of about 600-3000;
- a biodegradable, crystallization-controlling agent selected from the group consisting of calcium carbonate, hydroxyapatite, calcium phosphate, calcium apatite, calcium sulfate, calcium bicarbonate, calcium chloride, sodium carbonate, sodium bicarbonate, sodium chloride, calcium stearate, calcium palmitate, sodium stearate, dextran, starch, sodium carboxymethyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, poly(vinyl alcohol), glycerol palmitate, glycerol stearate, triethyl citrate, ethyl lactate, poly(ethylene glycol), poly(vinyl pyrrolidone), poly(lactide-co-caprolactone), and combinations thereof;
- an effective amount of a biologically active agent;
- and
- one or more additives selected from the group consisting of a biologically-active agent, a coloring agent, a release rate modification agent, and a pore forming agent;
- the composition being a moldable mass wherein crystalline regions of the poly(caprolactone) polymer are substantially uniformly distributed throughout;
- wherein the composition provides an effective amount of hemostasis in the defect, promotes tissue regrowth in the defect, or a combination thereof.
5 more elements
Dependencies are inferred from the claim text.