Nasal calcitonin formulations containing chlorobutanol

1. A method for intranasal administration of calcitonin which comprises administering intranasally to an individual a solution of calcitonin consisting of calcitonin, chlorobutanol at a concentration of 0.25% weight/weight, and water and having a pH of about 3.5, sodium chloride at a concentration of about 0.85%, and optionally hydrochloric acid in an amount sufficient to adjust the pH of the solution to about 3.5, and wherein the aqueous solution has an oxygen at a content of less than about 5%.

2. The method of claim 1 wherein the calcitonin is present in solution at a concentration of about 0.0355 weight/weight.

3. The method of claim 1 wherein the calcitonin formulation is administered into a nose of an individual through an actuator tip as a spray, wherein the spray has a spray pattern ellipticity ratio of from about 1.0 to about 1.4 when measured at a height of 3.0 cm from the actuator tip.

4. The method of claim 3 wherein the spray produces droplets, wherein less that 5% of the droplets are less than 10 microns in size.

5. The method of claim 3 wherein the spray has a spray pattern major axis of about 31.2 mm and a minor axis of about 27.4 mm.

6. A composition consisting of:

an aqueous solution of calcitonin at a concentration of about 0.0355% weight/weight;

chlorobutanol at a concentration of between about 0.25% and about 0.4% weight/weight;

sodium chloride at a concentration of about 0.85% weight/weight;

wherein the solution has a pH between about 3 to 4 and less than about 5% oxygen;

wherein the composition is suitable for intranasal administration in humans.

7. A composition consisting of:

an aqueous solution of salmon calcitonin at a concentration of 2200 International Units (I.U.) per ml;

chlorobutanol at a concentration of between 0.25% and about 0.4% weight/weight;

sodium chloride at a concentration of 0.85% weight/weight;

wherein the solution has a pH between about 3 to 4 and less than about 5% oxygen; and

wherein the composition is suitable for intranasal administration in humans.

8. A pharmaceutical composition consisting of:

an aqueous solution of salmon calcitonin at a concentration of 2200 International Units (I.U.) per ml;

chlorobutanol at a concentration of between 0.25% and about 0.4% weight/weight;

sodium chloride at a concentration of 0.85% weight/weight;

wherein the solution has a pH between about 3 to 4 and less than about 5% oxygen; and

wherein the composition is suitable for intranasal administration in humans.

9. A pharmaceutical device comprising a composition according to claim 6 and an actuator to produce an aerosol spray of the composition, the spray having a spray pattern ellipticity ratio of from about 1.0 to about 1.4 when measured at a height of 3.0 cm from the actuator tip.

10. A pharmaceutical device comprising a composition according to claim 6 and an actuator to produce an aerosol spray of the composition, wherein the spray has a spray pattern major axis of about 31.2 mm and a minor axis of about 27.4 mm.

11. A pharmaceutical device comprising a composition according to claim 6 and an actuator to produce an aerosol spray of the composition, the spray having a spray pattern ellipticity ratio of from about 1.0 to about 1.4 when measured at a height of 3.0 cm from the actuator tip, wherein less than 5% of the droplets are smaller than 10 microns in size.

12. A pharmaceutical device comprising a composition according to claim 7 and an actuator to produce an aerosol spray of the composition, the spray having a spray pattern ellipticity ratio of from about 1.0 to about 1.4 when measured at a height of 3.0 cm from the actuator tip.

13. A pharmaceutical device comprising a composition according to claim 7 and an actuator to produce an aerosol spray of the composition, wherein the spray has a spray pattern major axis of about 31.2 mm and a minor axis of about 27.4 mm.

14. A pharmaceutical device comprising a composition according to claim 7 and an actuator to produce an aerosol spray of the composition, the spray having a spray pattern ellipticity ratio of from about 1.0 to about 1.4 when measured at a height of 3.0 cm from the actuator tip, wherein less than 5% of the droplets are smaller than 10 microns in size.

15. A pharmaceutical device comprising a composition according to claim 8 and an actuator to produce an aerosol spray of the composition, the spray having a spray pattern ellipticity ratio of from about 1.0 to about 1.4 when measured at a height of 3.0 cm from the actuator tip.

16. A pharmaceutical device comprising a composition according to claim 8 and an actuator to produce an aerosol spray of the composition, wherein the spray has a spray pattern major axis of about 31.2 mm and a minor axis of about 27.4 mm.

17. A pharmaceutical device comprising a composition according to claim 8 and an actuator to produce an aerosol spray of the composition, the spray having a spray pattern ellipticity ratio of from about 1.0 to about 1.4 when measured at a height of 3.0 cm from the actuator tip, wherein less than 5% of the droplets are smaller than 10 microns in size.

18. A composition consisting of a solution of (i) calcitonin at a concentration of about 0.0355% weight/weight; (ii) chlorobutanol at a concentration of equal to or greater than about 0.25% and less than about 0.4% weight/weight; (iii) water; (iv) sodium chloride at a concentration of about 0.85% weight/weight:; and optionally (v) hydrochloric acid; wherein the composition has a pH of 4 or less; and wherein the composition is suitable for intranasal administration in humans.

19. A composition consisting of a solution of calcitonin at a concentration of 2200 International Units (I.U.) per ml, chlorobutanol at a concentration of about 0.25% weight/weight, water, sodium chloride at a concentration of 0.85% weight/weight, and optionally hydrochloric acid, wherein the composition has a pH of 4 or less, and wherein the composition is suitable for intranasal administration in humans.