Direct drug delivery system based on thermally responsive biopolymers

التفاصيل البيبلوغرافية
العنوان: Direct drug delivery system based on thermally responsive biopolymers
Document Number: 20070009602
تاريخ النشر: January 11, 2007
Appl. No: 11/472113
Application Filed: June 21, 2006
مستخلص: A method for delivering a drug depot of a compound of interest to a selected region in a subject. The method comprises administering a composition directly to said region of interest, the composition comprising the compound of interest to be delivered (such as an antiinflammatory agent or a chemotherapeutic agent) and a polymer (such as an elastin-like peptide or ELP) that undergoes an inverse temperature phase transition, so that a sustained release of the compound of interest at the selected region is provided. Compositions useful for carrying out the invention are also described.
Inventors: Setton, Lori A. (Durham, NC, US); Chilkoti, Ashutosh (Durham, NC, US); Kraus, Virginia B. (Hillsborough, NC, US); Betre, Helawe (Durham, NC, US); Dreher, Matthew R. (Durham, NC, US)
Claim: 1. A method for delivering a drug depot of a compound of interest to a selected region in a subject, said method comprising: administering a composition directly to said region of interest, said composition comprising said compound to be delivered and a polymer that undergoes an inverse temperature phase transition; so that a sustained release of said compound of interest at said selected region is provided; wherein said polymer has a transition temperature (Tt) less than the body temperature of said subject.
Claim: 2. The method of claim 1, wherein said composition aggregates in the region of interest and then gradually disaggregates, thereby providing said sustained release of said compound of interest at said selected region.
Claim: 3. The method of claim 1, wherein said administering step is carried out by injection.
Claim: 4. The method of claim 1, wherein said administering step is carried out by injection through a needle or cannula, wherein said needle or cannula is of 7 to 33 gauge.
Claim: 5. The method of claim 1, wherein said region of interest is a joint.
Claim: 6. The method of claim 1, wherein said region of interest is a joint, said compound of interest is an antiinflammatory compound, said patient is afflicted with osteoarthritis, and said composition is administered in an amount effective to treat said osteoarthritis.
Claim: 7. The method of claim 1, wherein said administering step is carried out by intra-articular injection.
Claim: 8. The method of claim 1, wherein said patient is afflicted with diarthrodial joint disorder and/or intervertebral disc pathology.
Claim: 9. The method of claim 1, wherein said region of interest is an intervertebral disc space.
Claim: 10. The method of claim 1, wherein said region of interest is a solid tumor.
Claim: 11. The method of claim 1, wherein said region of interest is a solid tumor with which said subject is afflicted, and said composition is administered in an amount effective to treat said solid tumor.
Claim: 12. The method of claim 1, wherein said administering step is repeated on a plurality of occasions at a frequency not greater than three times a month.
Claim: 13. The method of claim 1, wherein said composition comprises said compound to be delivered conjugated to said polymer that undergoes an inverse temperature phase transition.
Claim: 14. The method of claim 1, wherein said polymer is a bioelastic polymer, said bioelastic polymer comprising elastomeric units selected from the group consisting of bioelastic pentapeptides, tetrapeptides, and nonapeptides.
Claim: 15. The method of claim 1, wherein said compound of interest is a protein or peptide.
Claim: 16. The method of claim 1, wherein said compound of interest is an antiinflammatory compound selected from the group consisting of TNF blocking antibodies, IL-1 antibodies, soluble TNF receptors, soluble IL-1 receptors, TNF receptor antagonists, and IL-1 receptor antagonists.
Claim: 17. The method of claim 1, wherein said compound of interest is recombinant human IL-1 receptor antagonist.
Claim: 18. The method of claim 1, wherein said therapeutic compound is conjugated to said polymer.
Claim: 19. The method of claim 1, wherein said therapeutic compound is mixed with said polymer.
Claim: 20. A pharmaceutically acceptable composition comprising a therapeutic compound in combination with a polymer that undergoes an inverse temperature phase transition.
Claim: 21. The composition of claim 20, wherein said therapeutic compound is selected from the group consisting of antiinflammatory agents and chemotherapeutic agents.
Claim: 22. The composition of claim 20, wherein said therapeutic compound is an antiinflammatory agent.
Claim: 23. The composition of claim 20, wherein said therapeutic compound is an antiinflammatory agent selected from the group consisting of TNF antibodies, IL-1 antibodies, soluble TNF receptors, soluble IL-1 receptors, TNF receptor antagonists, and IL-1 receptor antagonists.
Claim: 24. The composition of claim 20, wherein said therapeutic compound is recombinant human IL-1 receptor antagonist
Claim: 25. The composition of claim 20, wherein said therapeutic compound is a chemotherapeutic agent.
Claim: 26. The composition of claim 20, wherein said therapeutic compound is conjugated to said polymer.
Claim: 27. The composition of claim 20, wherein said therapeutic compound is mixed with said polymer.
Claim: 28. An injection device containing a composition of claim 20 in sterile injectable form.
Claim: 29. The injection device of claim 28, wherein said injection device is a syringe.
Current U.S. Class: 424486/000
Current International Class: 61; 61; 61
رقم الانضمام: edspap.20070009602
قاعدة البيانات: USPTO Patent Applications