COMPOSITIONS AND METHODS FOR TREATING PERIODONTAL DISEASE COMPRISING CLONIDINE, SULINDAC AND/OR FLUOCINOLONE

• US 20100098746A1
• Filed: 10/02/2009
• Published: 04/22/2010
• Est. Priority Date: 10/20/2008
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: King, Vanja Margareta
• Application Number:
  US12/572,387
• Publication Number:
  US 20100098746A1
• Time in Patent Office: Days
• US Class Current: 424/435
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/4168 having a nitrogen attached in position 2, e.g. clonidine
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0063 Periodont
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants

Abstract

Effective treatments of periodontal disease for extended periods of time are provided. Through the administration of an effective amount of clonidine, sulindac, and/or fluocinolone at or near a target site, one can reduce, prevent, and/or treat periodontal disease. In some embodiments, when appropriate formulations are provided within biodegradable polymers, treatment can be continued for at least two weeks to two months.

Claims

1. An implantable drug depot for reducing, preventing or treating periodontal disease in a patient in need of such treatment, the implantable drug depot comprising clonidine in an amount from about 1 wt. % to about 20 wt. % of the drug depot, fluocinolone in an amount from about 0.05 wt. % to about 25 wt. % of the drug depot, and/or sulindac in an amount from about 5 wt. % to about 40 wt. % of the drug depot, and at least one biodegradable polymer, wherein the drug depot is capable of releasing clonidine, fluocinolone and/or sulindac over a period of at least two weeks.

2. An implantable drug depot according to claim 1, wherein the clonidine comprises from about 5 wt. % to about 15 wt. % of the drug depot, the sulindac comprises from about 5 wt. % to about 15 wt. % of the drug depot;

and/or the fluocinolone comprises from about 1 wt. % to about 15 wt. % of the drug depot.

3. An implantable drug depot according to claim 1, wherein said at least one biodegradable polymer comprises at least 80 wt. % to 90 wt. % of the drug depot.

4. An implantable drug depot according to claim 1, wherein the at least one biodegradable polymer comprises one or more of poly(lactide-co-glycolide) (PLGA), polylactide (PLA), polyglycolide (PGA), D-lactide, D,L-lactide, L-lactide, D,L-lactide-ε

-caprolactone, D,L-lactide-glycolide-ε

-caprolactone or a combination thereof.

5. An implantable drug depot according to claim 4, wherein the at least one biodegradable polymer comprises poly(lactic-co-glycolide) and said poly(lactic-co-glycolide) comprises a mixture of polyglycolide and polylactide.

6. An implantable drug depot according to claim 5, wherein said mixture comprises more polylactide than polyglycolide.

7. An implantable drug depot according to claim 1, wherein the clonidine comprises clonidine hydrochloride, the sulindac comprises sulindac sodium, and/or the fluocinolone comprises fluocinolone acetonide.

8. An implantable drug depot according to claim 1, wherein the drug depot releases:

(i) a bolus dose of the clonidine, sulindac, and/or fluocinolone at a site in the oral cavity and/or (ii) an effective amount of the clonidine, sulindac, and/or fluocinolone over a period of at least two weeks to two months.

9. An implantable drug depot according to claim 1, wherein the at least one biodegradable polymer comprises poly(lactic-co-glycolide) or poly(orthoester) or a combination thereof, and said at least one biodegradable polymer comprises at least 80 wt. % of said drug depot.

10. An implantable drug depot for reducing, preventing or treating periodontal disease in a patient in need of such treatment, the implantable drug depot comprising clonidine hydrochloride in an amount of from about 1 wt. % to about 20 wt. % of the drug depot, fluocinolone acetonide in an amount from about 0.05 wt. % to about 25 wt. % of the drug depot, and/or sulindac sodium in an amount from about 20 wt. % to about 40 wt. % of the drug depot, and at least one polymer, wherein the at least one polymer comprises one or more of poly(lactide-co-glycolide) (PLGA), polylactide (PLA), polyglycolide (PGA), D-lactide, D,L-lactide, L-lactide, D,L-lactide-ε

-caprolactone, D,L-lactide-glycolide-ε

-caprolactone or a combination thereof.

11. An implantable drug depot according to claim 10, wherein said at least one biodegradable polymer comprises at least 80 wt. % to 90 wt. % of the drug depot.

12. An implantable drug depot according to claim 10, wherein the at least one biodegradable polymer comprises and said poly(lactic-co-glycolide) comprises a mixture of polyglycolide and polylactide.

13. An implantable drug depot according to claim 12, wherein said mixture comprises more polylactide than polyglycolide.

14. A method for treating periodontal disease in a patient in need of such treatment, the method comprises implanting into an oral cavity of the patient a drug depot comprising clonidine in an amount of from about 1 wt. % to about 20 wt. % of the drug depot, fluocinolone in an amount from about 0.05 wt. % to about 25 wt. % of the drug depot, and/or sulindac in an amount from about 5 wt. % to about 40 wt. % of the drug depot, and at least one biodegradable polymer, wherein the drug depot is capable of releasing clonidine, fluocinolone and/or sulindac over a period of at least two weeks.

15. A method according to claim 14, wherein said clonidine comprises from about 5 wt. % to about 15 wt. % of the drug depot, the fluocinolone comprises from about 1 wt. % to about 15 wt. % of the drug depot, and/or the sulindac comprises from about 5 wt. % to about 15 wt. % of the drug depot.

16. A method according to claim 14, wherein the clonidine comprises clonidine hydrochloride, the sulindac comprises sulindac sodium, and/or the fluocinolone comprises fluocinolone acetonide.

17. A method according to claim 14, wherein said biodegradable polymer comprises at least 80 wt. % to 90 wt. % of the drug depot.

18. A method according to claim 14, wherein the at least one biodegradable polymer comprises one or more of poly(lactide-co-glycolide) (PLGA), polylactide (PLA), polyglycolide (PGA), D-lactide, polyorthoester (POE), D,L-lactide, L-lactide, D,L-lactide-caprolactone, D,L-lactide-glycolide-caprolactone or a combination thereof.

19. A method according to claim 18, wherein the at least one biodegradable polymer comprises poly(lactic-co-glycolide) and said poly(lactic-co-glycolide) comprises a mixture of polyglycolide and polylactide.

20. A method according to claim 14, wherein the implanting comprises administering one or more drug depots at a plurality of sites that triangulate a periodontal diseased tissue in of the oral cavity.