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Claims for Patent: 5,759,565

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Claims for Patent: 5,759,565

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:07/815,457
Patent Claims: 1. A liquid pharmaceutical composition comprising 1) a pharmaceutically acceptable, aqueous liquid nasal carrier; 2) 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 3) about 0.002% to about 0.02% on a weight per volume basis of a benzalkonium chloride, said composition being in a form suitable for nasal administration.

2. 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.

3. A composition according to claim 1 wherein said composition is in the form of a nasal spray.

4. A composition according to claim 1 wherein said carrier comprises aqueous saline.

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

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

7. A composition according to claim 1 -wherein said calcitonin, or salt is present in an amount of from about 500 to about 2,500 MRC units/ml.

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

9. A composition according to claim 1 wherein said calcitonin is salmon calcitonin.

10. A composition according to claim 1 comprising a non-ionic surfactant.

11. A composition according to claim 1 comprising a polyoxyethylene or polyoxypropylene ether.

12. A composition according to claim 1 comprising a polyoxyalkylene lauryl, cetyl, lanosteryl, dihydrocholesteryl or cholesteryl ether.

13. A composition according to claim 1 comprising a polyoxyethylene lauryl, cetyl or cholesteryl ether.

14. A composition according to claim 13 comprising a polyoxyethylene cholesteryl ether in which the number of repeating units in the polyoxyethylene moiety is from 16 to 26.

15. A composition according to claim 10 wherein said surfactant is present in an amount of from about 2.0 to about 200 mg/ml.

16. A composition according to claim 10 wherein said surfactant is present in an amount of from about 5 to about 15 mg/ml.

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

18. A composition according to claim 17 having a pH of from about 3.5 to 4.5.

19. A composition according to claim 17 comprising hydrochloric acid as the means to obtain the desired pH.

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