Implantable elastomeric caprolactone depot compositions and uses thereof
OwnerGuohua Chen, Lothar Kleiner +3inventors
InventorsGuohua Chen, Lothar Kleiner, Paul Houston, Aruna Nathan, Joel Rosenblatt
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Abstract
Methods and compositions for systemically or locally administering a beneficial agent to a subject are described, and include, for example, implantable elastomeric depot compositions that can be injected into a desired location and which can provide controlled release of a beneficial agent over a prolonged duration of time. The compositions include a biocompatible, elastomeric caprolactone copolymer, a biocompatible solvent having low water miscibility that forms an elastomeric viscous gel with the polymer and limits water uptake by the implant, and a beneficial agent.
Claims33
An implantable elastomeric depot composition for sustained delivery of a beneficial agent to a subject in a controlled manner over a predetermined duration of time after administration comprising:
- an elastomeric viscous gel formulation comprising a bioerodible, biocompatible, elastomeric polymer that is a caprolactone copolymer and a solvent having a miscibility in water of less than or equal to 7 wt. % at 25° C., in an amount effective to plasticize the copolymer and form a gel therewith;
- and
- a beneficial agent dissolved or dispersed in the gel, wherein said beneficial agent is delivered over a duration equal to or greater than two weeks.
An implantable elastomeric depot composition for sustained systemic delivery of a beneficial agent to a subject in a controlled manner over a duration equal to or greater than one week after administration comprising:
- an elastomeric viscous gel formulation comprising:
- a bioerodible, biocompatible elastomeric polymer having monomer components of caprolactone, glycolic acid and lactic acid having a comonomer component caprolactone/glycolic acid ratio of from about 10:75 to about 60:25;
- and
- a solvent having a miscibility in water of less than or equal to 7 wt. % at 25° C., in an amount effective to plasticize the polymer and form a gel therewith;
- and
- a beneficial agent dissolved or dispersed in the gel.
A method of administering a beneficial agent to a subject in a controlled manner, comprising:
- administering an implantable elastomeric depot composition to form an implant at a site of the subject to provide sustained release of the beneficial agent at the site, the depot composition comprising a bioerodible, biocompatible, elastomeric polymer that is a caprolactone copolymer and a solvent having a miscibility in water of less than or equal to 7 wt. % at 25° C., in an amount effective to plasticize the copolymer and form a gel therewith;
- and a beneficial agent dissolved or dispersed in the gel.
A method of making an implantable elastomeric depot composition for sustained delivery of a beneficial agent to a subject in a controlled manner over a predetermined duration of time after administration comprising:
- providing an elastomeric viscous gel formulation comprising a bioerodible, biocompatible, elastomeric caprolactone polymer and a solvent having a miscibility in water of less than or equal to 7 wt. % at 25° C., in an amount effective to plasticize the polymer and form a gel therewith;
- and
- incorporating a beneficial agent into the elastomeric viscous gel formulation.
Dependencies are inferred from the claim text.