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Last Updated: April 18, 2024

Claims for Patent: 5,759,565

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Summary 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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