Treating inflammation and inflammatory pain in mucosa using mucosal prolonged release bioadhesive therapeutic carriers

1. A method of preventing oral mucositis in a chemotherapy or radiation therapy cancer patient comprising administering to the oral cavity of the patient a pharmaceutical composition comprising an effective amount of clonidine or a pharmaceutically acceptable salt thereof.

2. The method of claim 1 , wherein the oral mucositis is due to chemotherapy or radiation therapy.

3. The method of claim 1 , wherein the patient is immunodepressed.

4. The method of claim 1 , wherein the pharmaceutical composition further comprises a therapeutically effective amount of a second active ingredient selected from an antiviral agent, an antifungal, an analgesic, an anesthetic, an antalgic, an anti-inflammatory agent, an antiemetic, an antibiotic, an antiseptic, a salivation agent, and mixtures thereof.

5. The method of claim 1 , wherein the clonidine or pharmaceutically acceptable salt thereof is present in the composition in an amount from 0.05 to 0.4 mg.

6. The method of claim 1 , wherein the clonidine or pharmaceutically acceptable salt thereof comprises 0.05 mg or 0.1 mg base equivalents of clonidine hydrochloride.

7. The method of claim 1 , wherein the pharmaceutical composition is in the form of a mucoadhesive tablet and comprises a mucosal bioadhesive slow release carrier, which comprises:

at least one diluent;

at least one bioadhesive agent; and

at least one sustained release agent that provides sustained release of the clonidine or pharmaceutically acceptable salt thereof;

wherein the clonidine or pharmaceutically acceptable salt thereof is present in the composition in an amount from 0.05 to 0.4 mg.

8. The method of claim 7 , wherein the mucosal bioadhesive slow release carrier comprises:

0.001 to 10% by weight of the clonidine or pharmaceutically acceptable salt thereof;

1 to 75% by weight of the at least one diluent;

5 to 80% by weight of the at least one bioadhesive agent; and

5 to 80% by weight of the at least one sustained release agent.

9. The method of claim 8 , wherein the clonidine or pharmaceutically acceptable salt thereof comprises 0.05 mg or 0.1 mg base equivalents of clonidine hydrochloride.

10. The method of claim 8 , wherein the pharmaceutical composition is administered once daily.

11. The method of claim 1 , wherein the pharmaceutical composition is administered prior to the patient starting chemotherapy or the radiation therapy.

12. The method of claim 11 , wherein the pharmaceutical composition is administered one day prior to the patient starting radiation therapy.

13. The method of claim 1 , wherein the patient has cancer of the head and neck.

14. The method of claim 1 , wherein the pharmaceutical composition is administered during ongoing chemotherapy or radiation therapy.

15. The method of claim 1 , wherein the clonidine or pharmaceutically acceptable salt thereof is the sole active ingredient in the pharmaceutical composition.

16. A method of preventing oral mucositis in a chemotherapy or radiation therapy cancer patient comprising administering to the oral cavity of the patient a pharmaceutical composition comprising an effective amount of clonidine or a pharmaceutically acceptable salt thereof, wherein

the pharmaceutical composition comprises a mucosal bioadhesive slow release carrier that provides for sustained release of the clonidine or pharmaceutically acceptable salt thereof; and

the clonidine or pharmaceutically acceptable salt thereof is present in the composition in an amount from 0.05 to 0.4 mg.

17. The method of claim 16 , wherein the clonidine or pharmaceutically acceptable salt thereof comprises 0.05 mg or 0.1 mg base equivalents of clonidine hydrochloride.

18. The method of claim 16 , wherein the pharmaceutical composition is administered once daily.

19. The method of claim 16 , wherein the pharmaceutical composition is administered prior to the patient starting chemotherapy or the radiation therapy.

20. The method of claim 19 , wherein the pharmaceutical composition is administered one day prior to the patient starting radiation therapy.

21. The method of claim 16 , wherein the patient has cancer of the head and neck.

22. The method of claim 16 , wherein the pharmaceutical composition is administered during ongoing chemotherapy or radiation therapy.

23. The method of claim 16 , wherein the clonidine or pharmaceutically acceptable salt thereof is the sole active ingredient in the pharmaceutical composition.

24. The method of claim 16 , wherein the pharmaceutical composition is in the form of a mucoadhesive tablet.

25. A method of preventing severe oral mucositis in a chemotherapy or radiation therapy cancer patient comprising administering to the oral cavity of the patient prior to the onset of oral mucositis a pharmaceutical composition comprising an effective amount of clonidine or a pharmaceutically acceptable salt thereof.

26. The method of claim 25 , wherein the clonidine or pharmaceutically acceptable salt thereof is present in the composition in an amount from 0.05 to 0.4 mg.

27. The method of claim 25 , wherein the clonidine or pharmaceutically acceptable salt thereof comprises 0.05 mg or 0.1 mg base equivalents of clonidine hydrochloride.

28. The method of claim 25 , wherein the pharmaceutical composition is administered prior to the patient starting chemotherapy or the radiation therapy.

29. The method of claim 25 , wherein the patient has cancer of the head and neck.

30. The method of claim 25 , wherein the pharmaceutical composition is administered during ongoing chemotherapy or radiation therapy.