Polymeric devices for controlled release of active agents
Polymeric devices for controlled release of an active agent of interest are provided. The active agent is provided within a biodegradable polymer system to supply a polymeric device for controlled release of the active agent. The polymer system is a copolymer or a polymer blend comprising a hydrophobic component and a hydrophilic component, and the polymer system does not form a hydrogel when contacted with, or immersed in an aqueous system, for example when the device is implanted in a subject. When the device is administered to a subject, for example, when it is implanted, the device releases the active agent in a controlled fashion without a lag period, or with a minimal lag period. Methods for producing the polymeric devices are also provided, as are methods of using the polymeric devices to provide for controlled release of an active agent in a subject.
1. A polymeric device for controlled release of an active agent of interest, said device comprising
a biodegradable polymer system, wherein said polymer system comprises an AB copolymer, wherein the A component comprises a hydrophobic poly(lactide-co-glycolide) and the B component comprises a hydrophilic polyalkyleneglycol; and
an active agent, wherein the polymer system does not form a hydrogel when the device is contacted with an aqueous system.
2. The device of claim 1 , wherein the active agent is a peptide.
3. The device of claim 2 , wherein the peptide is a therapeutic and/or prophylactic peptide selected from the group consisting of hormones, growth factors, neuroactive agents, melanotropic peptides, cell adhesion factors, cytokines, and biological response modifiers.
4. The device of claim 1 , wherein the hydrophilic B component is present in the polymer system in an amount of up to 25 wt %.
5. The device of claim 4 , wherein the hydrophilic B component is present in the polymer system in an amount of up to 15 wt %.
6. The device of claim 1 , wherein the hydrophilic B component is present in the polymer system in an amount of between 0.5 and 10 wt %.
7. The device of claim 1 , wherein the active agent is distributed uniformly within the polymer system.
8. The device of claim 1 , wherein the active agent is released from the device with linear or near zero order release kinetics.
9. The device of claim 1 , wherein the polymer system comprises greater than 75 wt % of the hydrophobic A component.
10. The device of claim 9 , wherein the polymer system comprises greater than 85 wt % of the hydrophobic A component.
11. The device of claim 10 , wherein the polymer system comprises greater than 91 wt % of the hydrophobic A component.
12. The device of claim 11 , wherein the polymer system comprises greater than 98 wt % of the hydrophobic A component.
13. The device of claim 1 provided in the form of a fiber, needle or rod.
14. The device of claim 1 provided in the form of a sheet, film or coating.
15. The device of claim 1 provided in microparticulate form.
16. The device of claim 1 free of solvent residue.
17. The device of claim 1 , wherein the active agent is a GnRH molecule or a GnRH analog.
18. The device of claim 17 , wherein the GnRH analog is selected from the group consisting of desorelin, tryptorelin, goserelin, and leuprolide.
19. A polymeric device for controlled release of an active agent of interest, said device comprising
a biodegradable polymer system, wherein said polymer system comprises an AB copolymer, wherein the A component comprises a hydrophobic poly(lactide-co-glycolide) and the B component comprises a hydrophilic polyalkyleneglycol; and
an active agent, wherein the polymer system does not form a hydrogel when the device is contacted with an aqueous system, and wherein the active agent is incorporated into the polymer system using a non-solvent process.
20. A polymeric device for controlled release of an active agent of interest, said device comprising
a biodegradable polymer system, wherein said polymer system comprises an AB copolymer, wherein the A component comprises a hydrophobic poly(lactide-co-glycolide) and the B component comprises a hydrophilic polyalkyleneglycol; and
an active agent, wherein the polymer system does not form a hydrogel when the device is contacted with an aqueous system, and wherein the device is formed by dry melt extrusion.
21. A polymeric device for controlled release of an active agent of interest, said device comprising
a biodegradable polymer system, wherein said polymer system comprises an AB copolymer, wherein the A component comprises a hydrophobic poly(lactide-co-glycolide) and the B component comprises a hydrophilic polyalkyleneglycol; and
an active agent, wherein the polymer system does not form a hydrogel when the device is contacted with an aqueous system, and wherein the device is formed by melt extrusion of the copolymer mixed with the active agent.
22. The polymeric device of claim 1 , 19 , 20 or 21 , wherein the AB copolymer is a block copolymer.
23. The device of claim 19 , 20 or 21 , wherein the active agent is released from the device with linear or near zero order release kinetics.
24. The device of claim 1 , wherein the device releases the agent without a lag period or with a minimal lag period.
25. The device of claim 19 , wherein the device releases the agent without a lag period or with a minimal lag period.
26. The device of claim 20 , wherein the device releases the agent without a lag period or with a minimal lag period.
27. The device of claim 21 , wherein the device releases the agent without a lag period or with a minimal lag period.