Compositions and use of varenicline for treating dry eye
Described herein are methods and pharmaceutical formulations for treating dry eye disease.
1. A pharmaceutical formulation for local administration into a nasal cavity of an individual, the formulation comprising varenicline or a pharmaceutically acceptable varenicline salt and one or more pharmaceutically acceptable inactive ingredients, wherein varenicline in the formulation is in an amount of between 5 micrograms and 1000 micrograms, and the concentration of varenicline in the formulation is between about 0.1 mg/mL and about 10 mg/mL.
2. The pharmaceutical formulation of claim 1 , wherein the amount of varenicline in the formulation is between 5 micrograms and 100 micrograms.
3. The pharmaceutical formulation of claim 1 , wherein the amount of varenicline in the formulation is between 5 micrograms and 600 micrograms.
4. The pharmaceutical formulation of claim 1 , wherein the amount of varenicline in the formulation is between 5 micrograms and 500 micrograms per dose.
5. The pharmaceutical formulation of claim 1 , wherein the amount of varenicline in the formulation is between 5 micrograms and 75 micrograms per dose.
6. The pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation is a liquid, suspension, aerosol, gel, ointment, dry powder, cream, paste, lotion, or balm.
7. The pharmaceutical formulation of claim 1 , wherein the formulation comprises a solution of the varenicline or varenicline salt.
8. The pharmaceutical formulation of claim 7 , wherein the formulation is a liquid.
9. The pharmaceutical formulation of claim 8 , wherein the formulation is administered as a nasal spray.
10. The pharmaceutical formulation of according to claim 1 , wherein the formulation comprises a buffer.
11. The pharmaceutical formulation of claim 10 , wherein the buffer comprises a phosphate buffer or a phosphate-citrate buffer.
12. The pharmaceutical formulation of claim 11 , comprising a phosphate buffer with a pH of from around 5.0 to around 7.4.
13. The pharmaceutical formulation of claim 11 , comprising a phosphate buffer with a pH of around 5.0, around 6.0, around 7.0 or around 7.4.
14. The pharmaceutical formulation of to claim 1 , wherein the amount of varenicline in the formulation is about 0.5 mg per mL of the formulation.
15. The pharmaceutical formulation of claim 9 , wherein the amount of varenicline in the formulation is about 0.5 mg per mL of the formulation.
16. A nasal spray of a liquid pharmaceutical formulation comprising a solution of varenicline or a pharmaceutically acceptable varenicline salt and one or more pharmaceutically acceptable inactive ingredients, the varenicline in the formulation being in an amount of 5 micrograms to 1000 micrograms, and the concentration of varenicline in the formulation being between about 0.1 mg/mL and about 10 mg/mL.
17. The nasal spray of a liquid pharmaceutical formulation of claim 16 , wherein the amount of varenicline in the formulation is between 5 micrograms and 100 micrograms.
18. The nasal spray of a liquid pharmaceutical formulation of claim 16 , wherein the amount of varenicline in the formulation is between 5 micrograms and 600 micrograms.
19. The nasal spray of a liquid pharmaceutical formulation of according to claim 16 , wherein the amount of varenicline in the formulation is between 5 micrograms and 500 micrograms.
20. The nasal spray of a liquid pharmaceutical formulation of claim 16 , wherein the amount of varenicline in the formulation is between 5 micrograms and 75 micrograms.
21. The nasal spray of a liquid pharmaceutical formulation of claim 16 , the formulation comprising a phosphate buffer or a phosphate-citrate buffer.
22. The nasal spray of a liquid pharmaceutical formulation of claim 16 , the formulation comprising a phosphate buffer with a pH of from around 5.0 to around 7.4.
23. A nasal spray bottle containing a liquid pharmaceutical formulation for local administration into a nasal cavity of an individual, the formulation comprising a solution of varenicline or a pharmaceutically acceptable varenicline salt and one or more pharmaceutically acceptable inactive ingredients, the varenicline in the formulation being in an amount of 5 micrograms to 1000 micrograms, and the concentration of varenicline in the formulation being between about 0.1 mg/mL and about 10 mg/mL.
24. The nasal spray bottle of claim 23 containing a liquid pharmaceutical formulation wherein the amount of varenicline in the formulation is 5 micrograms to 100 micrograms.
25. The nasal spray bottle of claim 23 , wherein each spray delivers about 50 microliters of the formulation.
26. The nasal spray bottle of claim 23 , wherein the pharmaceutical formulation comprises a phosphate buffer or a phosphate-citrate buffer.
27. The nasal spray bottle of claim 26 , wherein the pharmaceutical formulation comprises a phosphate buffer with a pH of from around 5.0 to around 7.4.
28. The nasal spray bottle of claim 26 , wherein the pharmaceutical formulation comprises a phosphate buffer with a pH of around 5.0, around 6.0, around 7.0 or around 7.4.
29. The nasal spray bottle of claim 25 , wherein each spray of about 50 microliters of the formulation contains from between 5 micrograms and 100 micrograms varenicline.
30. The nasal spray bottle of claim 25 , wherein each spray of about 50 microliters of the formulation contains from between 5 micrograms and 75 micrograms varenicline.