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Claims for Patent: 5,733,569

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Claims for Patent: 5,733,569

Title: Galenic compositions comprising calcitonin and their use
Abstract:Pharmaceutical compositions for nasal administration comprising i) a calcitonin, and ii) benzalkonium chloride, and/or iv) a surfactant, suitable for application to the nasal mucosa, in iii) a liquid diluent or carrier, suitable for application to the nasal mucosa. The compositions are suitably adapted for administration in the form of a nasal spray.
Inventor(s): Azria; Moise (Basel, CH), Cavanak; Thomas (Biel-Benken, CH)
Assignee: Novartis Corporation (Summit, NJ)
Application Number:08/471,118
Patent Claims: 1. A liquid pharmaceutical composition comprising in a form suitable for administration as a liquid nasal spray:

a a therapeutically effective amount of a calcitonin or a pharmaceutically acceptable acid addition salt thereof, wherein said calcitonin is selected from the group consisting of salmon calcitonin, human calcitonin, porcine calcitonin and 1.7-Asu-eel calcitonin;

b an effective amount of benzalkonium chloride to enhance the bioavailability of said calcitonin when administered, to the nasal mucosa, and

c a pharmaceutically acceptable, aqueous liquid nasal carrier.

2. A composition according to claim 1 having a pH of from about 3 to about 5.

3. A composition according to claim 2, having a pH of from about 3.5 to 4.5.

4. A composition according to claim 2 comprising hydrochloric acid as the means to obtain the desired pH.

5. A composition according to claim 1 having an osmotic pressure of from about 260 to 380 mOsm/liter.

6. A composition according to claim 1 for administration in the form of a spray and having a viscosity of less than 2.times.10.sup.-3 Pa.S.

7. An applicator device containing a pharmaceutical composition and provided with means enabling application of the contained composition to the nasal mucosa in spray form, said contained composition comprising:

i) a therapeutically effective amount of a calcitonin or a pharmaceutically acceptable acid addition salt thereof, wherein said calcitonin is selected from the group consisting of salmon calcitonin, human calcitonin, porcine calcitonin and 1.7-Asu-eel calcitonin; and

ii) an effective mount of benzalkonium chloride to enhance the bioavailability of said calcitonin when administered to the nasal mucosa, and

iii) a pharmaceutically acceptable, aqueous liquid nasal carrier.

8. A device according to claim 7 wherein said device is a nasal aerosol applicator.

9. A method of administering a calcitonin to a subject requiring calcitonin treatment, which method comprises administering a pharmaceutical composition comprising:

i) a therapeutically effective amount of a calcitonin or a pharmaceutically acceptable acid addition salt thereof, wherein said calcitonin is selected from the group consisting of salmon calcitonin, human calcitonin, porcine calcitonin and 1.7-Asu-eel calcitonin; and

ii) an effective amount of benzalkonium chloride to enhance the bioavailability of said calcitonin when administered to the nasal mucosa, and

iii) a pharmaceutically acceptable, aqueous liquid nasal carrier to said subject via the nasal route.

10. A composition according to claim 1 wherein said calcitonin or pharmaceutically acceptable acid addition salt thereof is salmon calcitonin.

11. A composition according to claim 1 wherein said calcitonin or pharmaceutically acceptable addition salt thereof is present in an amount of from about 100 to about 8,000 MRC units/ml.

12. A composition according to claim 1 wherein said calcitonin or pharmaceutically acceptable addition salt thereof is present in an amount of from about 500 to about 4,000 MRC units/ml.

13. A composition according to claim 1 wherein said calcitonin or pharmaceutically acceptable addition salt thereof is present in an amount of from about 500 to about 2,500 MRC units/ml.

14. A composition according to claim 1 wherein said calcitonin or pharmaceutically acceptable addition salt thereof is present in an amount of from about 1,000 to about 2,000 MRC units/ml.

15. A composition according to claim 1 wherein said liquid nasal carrier comprises aqueous saline.

16. A composition according to claim 1 which further comprises a non-ionic surfactant.

17. A composition according to claim 16 wherein said non-ionic surfactant is a polyoxyalkylene ether.

18. A composition according to claim 17 wherein said polyoxyalkylene ether is a polyoxyethylene ether, a polyoxypropylene ether or a polyoxyalkylene higher alcohol ether.

19. A composition according to claim 18 wherein said polyoxyalkylene higher alcohol ether is selected from the group consisting of polyoxyethylene lauryl ether, polyoxyethylene cetyl ether, polyoxyethylene cholesteryl ether, polyoxypropylene lauryl ether, polyoxypropylene cetyl ether, polyoxypropylene cholesteryl ether and mixtures thereof.

20. An applicator device according to claim 7 wherein said contained composition has a pH from about 3 to about 5.

21. An applicator device according to claim 7 wherein said contained composition contains about 0.002% to about 0.02% of said benzalkonium chloride on a weight per volume basis.

22. An applicator device according to claim 7 wherein said calcitonin or pharmaceutically acceptable acid addition salt thereof is salmon calcitonin.

23. An applicator device according to claim 7 wherein said calcitonin or pharmaceutically acceptable addition salt thereof is present in an amount of from about 500 to about 4,000 MRC units/ml.

24. An applicator device according to claim 7 wherein said liquid nasal carrier comprises aqueous saline.

25. A method according to claim 9 wherein said pharmaceutical composition has a pH from about 3 to about 5.

26. A method according to claim 9 wherein said calcitonin or pharmaceutically acceptable acid addition salt thereof is salmon calcitonin.

27. A method according to claim 9 wherein said pharmaceutical composition has an osmotic pressure of from about 260 to 380 mOsm/liter.

28. A method according to claim 9 wherein said pharmaceutical composition is administered by spraying.

29. A method according to claim 9 wherein said pharmaceutical composition contains about 0.002% to about 0.02% of said benzalkonium chloride on a weight per volume basis.

30. A method according to claim 9 wherein said pharmaceutical composition further comprises a non-ionic surfactant.

31. A method according to claim 30 wherein said non-ionic surfactant is a polyoxyalkylene ether.

32. A method according to claim 31 wherein said polyoxyalkylene ether is a polyoxyethylene ether, a polyoxypropylene ether or a polyoxyalkylene higher alcohol ether.

33. A method according to claim 32 wherein said polyoxyalkyene higher alcohol ether is selected from the group consisting of polyoxyethylene lauryl ether, polyoxyethylene cetyl ether, polyoxyethylene cholesteryl ether, polyoxypropylene lauryl ether, polyoxypropylene cetyl ether, polyoxypropylene cholesteryl ether and mixtures thereof.

34. A method according to claim 9 wherein said calcitonin or pharmaceutically acceptable addition salt thereof is present in an amount of from about 500 to about 4,000 MRC units/ml.

35. A method according to claim 9 wherein said liquid nasal carrier comprises aqueous saline.
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