Drug releasing biodegradable fiber for delivery of therapeutics

• US 20040028655A1
• Filed: 05/02/2003
• Published: 02/12/2004
• Est. Priority Date: 08/06/1999
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Nelson, Kevin D., Crow, Brent B.
• Granted Patent: US 7,033,603 B2
• Time in Patent Office: Days
• US Class Current: 424/93.2
• CPC Class Codes: A61K 47/6953 the form being a fibre, a textile, a slab or a sheet
• CPC Class Codes: A61K 51/1213 Semi-solid forms, gels, hydrogels, ointments, fats and waxes that are solid at room temperature
• 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: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092
• CPC Class Codes: A61L 15/16 Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/258 Genetic materials, DNA, RNA, genes, vectors, e.g. plasmids
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/426 Immunomodulating agents, i.e. cytokines, interleukins, interferons
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 2430/32 for nerve reconstruction
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 27/06 : Antiglaucoma agents or miotics
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/02 : Immunomodulators
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/00 : Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: D01F 1/10 : Other agents for modifying properties
• CPC Class Codes: D01F 6/625 : derived from hydroxy-carboxylic acids, e.g. lactones
• CPC Class Codes: D01F 8/14 : with at least one polyester as constituent
• CPC Class Codes: D06M 15/03 : Polysaccharides or derivatives thereof
• CPC Class Codes: D06M 16/00 : Biochemical treatment of fibres, threads, yarns, fabrics, or fibrous goods made from such materials, e.g. enzymatic

Abstract

The present invention relates to fiber compositions comprising gels or hydrogels. The invention further relates to the composition of a gel or hydrogel loaded biodegradable fiber and methods of fabricating such fibers. The present invention further provides tissue engineering and drug-delivery compositions and methods wherein three-dimensional matrices for growing cells are prepared for in vitro and in vivo use. The invention also relates to methods of manipulating the rate of therapeutic agent release by changing both the biodegradable polymer properties as well as altering the properties of the incorporated gel or hydrogel.

Claims

1. A drug delivery composition comprising at least one fiber, wherein said fiber comprises a first component and a second component, and wherein said first component is a biodegradable polymer and said second component is selected from the group consisting of a gel and a hydrogel.

2. The composition of claim 1 wherein said first component is present in the fiber bore and said second component is present in the fiber wall.

3. The composition of claim 1 wherein said second component is present in the fiber bore and said first component is present in the fiber wall.

4. The composition of claim 1 further comprising at least one additional fiber, wherein said additional fiber circumscribes an adjacent inner fiber.

5. The composition of claim 4 wherein said adjacent inner fiber is approximately centered within the outer fiber.

6. The composition of claim 1, wherein a therapeutic agent is loaded into the gel or hydrogel.

7. The composition of claim 6, wherein the therapeutic agent is a growth factor.

8. The composition of claim 7, wherein said growth factor is a promoter of angiogenesis.

9. The composition of claim 7, wherein said growth factor promotes nerve regeneration.

10. The composition of claim 6, wherein the therapeutic agent is a virus.

11. The composition of claim 6, wherein the therapeutic agent is selected from the group consisting of protein, enzymes, transcription factors, signaling molecules, internal messengers, second messengers, kinases, proteases, cytokines, chemokines, structural proteins, interleukins, hormones, anti-coagulants, pro-coagulants, anti-inflammatory agents, antibiotics, agents that promote angiogenesis, agents that inhibit angiogenesis, growth factors, immunomodulators, chemotactic agents, agents that promote apoptosis, agents that inhibit apoptosis, and mitogenic agents.

12. The composition of claim 1, wherein said gel or hydrogel is a precursor gel or precursor hydrogel.

13. The composition of claim 1, wherein said biodegradable polymer fiber comprises a hydrophobic drug.

14. The composition of claim 1, wherein said gel or hydrogel comprises a radioactive material.

15. A drug delivery composition comprising a fiber, wherein said fiber comprises a first component and a second component, and wherein said first component is a biodegradable polymer and said second component is water, and further wherein said water is present as an inner core.

16. The composition of claim 15 further comprising at least one additional fiber, wherein said additional fiber circumscribes an adjacent inner fiber.

17. The composition of claim 16 wherein said adjacent inner fiber is approximately centered within the outer fiber.

18. The composition of claim 15, wherein said biodegradable polymer fiber comprises a hydrophobic drug.

19. A drug delivery composition comprising a fiber, wherein said fiber comprises an emulsion consisting essentially of a gel or hydrogel.

20. A drug delivery composition comprising a fiber, wherein said fiber comprises a first component, and wherein said first component is a gel or hydrogel and further wherein said fiber comprises a hollow bore.

21. A scaffold composition comprising one or more fibers, wherein said fibers comprise a first component and a second component, and wherein said first component is a biodegradable polymer and said second component is selected from the group consisting of a gel and a hydrogel.

22. The composition of claim 21 wherein said first component is present in the fiber bore and said second component is present in the fiber wall.

23. The composition of claim 21 wherein said second component is present in the fiber bore and said first component is present in the fiber wall.

24. The composition of claim 21 further comprising at least one additional fiber, wherein said additional fiber circumscribes an adjacent inner fiber.

25. The composition of claim 24 wherein said adjacent inner fiber is approximately centered within the outer fiber.

26. The composition of claim 21, wherein therapeutic agent is loaded into the gel or hydrogel.

27. The composition of claim 26, wherein the therapeutic agent is a growth factor.

28. The composition of claim 27, wherein said growth factor is a promoter of angiogenesis.

29. The composition of claim 27, wherein said growth factor promotes nerve regeneration.

30. The composition of claim 26, wherein the therapeutic agent is a virus.

31. The composition of claim 26, wherein the therapeutic agent is selected from the group consisting of protein, enzymes, transcription factors, signaling molecules, internal messengers, second messengers, kinases, proteases, cytokines, chemokines, structural proteins, interleukins, hormones, anti-coagulants, pro-coagulants, anti-inflammatory agents, antibiotics, agents that promote angiogenesis, agents that inhibit angiogenesis, growth factors, immunomodulators, chemotactic agents, agents that promote apoptosis, agents that inhibit apoptosis, and mitogenic agents.

32. The composition of claim 21, wherein said gel or hydrogel is a precursor gel or precursor hydrogel.

33. The composition of claim 21, wherein said biodegradable polymer fiber comprises a hydrophobic drug.

34. The composition of claim 21, wherein said gel or hydrogel comprises a radioactive material.

35. A method of manufacturing a fiber wherein said fiber comprises a first component and a second component, and wherein said first component is a biodegradable polymer and said second component is selected from the group consisting of a gel and a hydrogel.

36. A method of manufacturing a fiber wherein said fiber comprises an emulsion consisting essentially of a gel or hydrogel.

37. A method of manufacturing a fiber, wherein said fiber comprises a first component, and wherein said first component is a gel or hydrogel and further wherein said fiber comprises a hollow bore.