Biodegradable Osmotic Pump Implant For Drug Delivery

• US 20120156289A1
• Filed: 12/21/2010
• Published: 06/21/2012
• Est. Priority Date: 12/21/2010
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Confluent Surgical, Inc. (Medtronic Plc)
• Inventors: Blaskovich, Phillip, Ohri, Rachit, Bennett, Steven
• Granted Patent: US 8,518,440 B2
• Time in Patent Office: Days
• US Class Current: 424/457
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

The present disclosure relates to a drug delivery device including a biodegradable housing and a hydrogel within the biodegradable housing. The housing, the hydrogel, or both, may include a bioactive agent. Also disclosed is a method of drug delivery including the steps of forming the biodegradable housing, in embodiments a hydrogel, suspending a bioactive agent in the hydrogel, and introducing a second hydrogel and/or precursors of a second hydrogel into the biodegradable housing.

Claims

1. A drug delivery device comprising:

a housing comprising a polymeric material; and

a biodegradable hydrogel within said housing;

wherein the polymeric material, the biodegradable hydrogel, or both, comprises a bioactive agent.

2. The drug delivery device of claim 1, wherein the biodegradable hydrogel within the housing is formed of a first precursor comprising electrophilic groups and a second precursor comprising nucleophilic groups.

3. The drug delivery device of claim 2, wherein the electrophilic groups comprise N-hydroxysuccinimides and the nucleophilic groups comprise amines.

4. The drug delivery device of claim 1, wherein the polymeric material comprises a second hydrogel capable of a changing in size of from about −

50% to about 50% by weight, and the biodegradable hydrogel swells by an amount of from about 40% by weight to about 600% by weight.

5. The drug delivery device of claim 1, wherein the polymeric material forming the housing comprises a first precursor comprising electrophilic groups and a second precursor comprising nucleophilic groups.

6. The drug delivery device of claim 5, wherein the first precursor comprises a multi-armed precursor possessing a core and arms, the arms each comprising a polyethylene glycol having a molecular weight from about 250 to about 5000.

7. The drug delivery device of claim 6, wherein the core is selected from the group consisting of polyethers, polyamino acids, proteins, and polysaccharides.

8. The drug delivery device of claim 6, wherein the core is selected from the group consisting of polyethylene glycol, polyethylene oxide, polyethylene oxide-co-polypropylene oxide, co-polyethylene oxide copolymers, polyvinyl alcohol, polyvinyl pyrrolidinone, dextran, chitosan, carboxymethylcellulose, oxidized cellulose, derivatives thereof, and combinations thereof.

9. The drug delivery device of claim 5, wherein the nucleophilic groups comprise amines.

10. The drug delivery device of claim 1, wherein the polymeric material comprises a low-swelling hydrogel capable of changing in size of from about −

20% by weight to about 40% by weight, and the biodegradable hydrogel swells by an amount of from about 100% by weight to about 400% by weight.

11. The drug delivery of claim 1, wherein the polymeric material is selected from the group consisting of oxidized cellulose, polylactide, polyglycolide, polylactide-co-glycolide copolymer, and combinations thereof.

12. The drug delivery device of claim 1, wherein the housing further comprises an inner layer and at least one outer layer.

13. The drug delivery device of claim 12, wherein the at least one outer layer is selected from the group consisting of oxidized cellulose, polylactide, polyglycolide, polylactide-co-glycolide copolymer, and combinations thereof.

14. The drug delivery device of claim 12, wherein the at least one outer layer comprises a molecular weight cut off membrane.

15. The drug delivery device of claim 1, wherein the bioactive agent is selected from the group consisting of local anesthetics, vitamins, hormones, and combinations thereof.

16. The drug delivery device of claim 1, wherein the housing is semi-permeable.

17. The drug delivery device of claim 1, wherein the bioactive agent is encapsulated in a polymeric microcapsule.

18. The drug delivery device of claim 1, wherein the drug delivery device possesses a shape selected from the group consisting of circular, discs, rods, cylinders, capsules, spheres, ovoids, pinwheels, nautilus, and combinations thereof.

19. A method of drug delivery comprising the steps of:

forming a housing comprising a polymeric material in situ;

introducing at least one bioactive agent and precursors comprising a biodegradable hydrogel into the housing; and

allowing the precursors to form the biodegradable hydrogel within the housing.

20. The method of claim 19, further comprising the step of hydrating the biodegradable hydrogel prior to filling the housing.

21. The method of claim 19, further comprising dehydrating the biodegradable hydrogel prior to filling the housing.

22. The method of claim 19, further comprising coating the housing with at least one outer layer.

23. The method of claim 22, wherein the housing is coated with from about 1 to about 10 outer layers.