Claims for Patent: 11,903,942

Summary for Patent: 11,903,942

Title:	Compositions and use of varenicline for treating dry eye
Abstract:	Described herein are methods and pharmaceutical formulations for treating dry eye disease.
Inventor(s):	Douglas Michael Ackermann, JR., James LOUDIN, Kenneth J. Mandell
Assignee:	Oyster Point Pharma Inc
Application Number:	US18/125,517
Patent Claims:	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.