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Claims for Patent: 8,383,611

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Claims for Patent: 8,383,611

Title:Ciclesonide containing aqueous pharmaceutical composition
Abstract: The present invention provides an aqueous pharmaceutical composition containing ciclesonide and hydroxypropyl-methylcellulose, wherein the ciclesonide is dispersed in an aqueous medium in the form of solid particles. The composition is able to avoid variations in the concentrations of ciclesonide during production as well as avoid decreases in the recovery rate of ciclesonide.
Inventor(s): Nagano; Atsuhiro (Tokyo, JP), Nishibe; Yoshihisa (Yamaguchi, JP), Takanashi; Kazuya (Tokyo, JP)
Assignee: Nycomed GmbH (Constance, DE)
Application Number:10/110,632
Patent Claims: 1. An aqueous pharmaceutical composition which comprises ciclesonide, crystalline cellulose carmellose sodium and hydroxypropylmethylcellulose, wherein said ciclesonide is uniformly dispersed in an aqueous medium in the form of solid particles, wherein said crystalline cellulose carmellose sodium concentration is 1.7% w/w, and wherein said hydroxypropylmethylcellulose concentration is 0.1% w/w, relative to the total amount of the composition.

2. An aqueous pharmaceutical composition according to claim 1 which further comprises one or more types of a water-insoluble substance and/or water-low soluble substance which is one or more types of cellulose.

3. An aqueous pharmaceutical composition according to claim 2, which further comprises a water-soluble polymer substance.

4. An aqueous pharmaceutical composition according to claim 3, wherein said water-soluble polymer substance is one or more types selected from the group consisting of polyethylene glycol, propylene glycol alginate, pectin, methoxyl pectin, guar gum, gum arabic, carrageenan, methylcellulose, xanthan gum and hydroxypropylcellulose.

5. An aqueous pharmaceutical composition according to claim 3, wherein said water-soluble polymer substance is polyethylene glycol.

6. An aqueous pharmaceutical composition according to claim 3, wherein said water-soluble polymer substance is hydroxypropylcellulose.

7. An aqueous pharmaceutical composition according to claim 1 which further comprises a water-soluble polymer substance.

8. An aqueous pharmaceutical composition according to claim 7, wherein said water-soluble polymer substance is one or more types selected from the group consisting of polyethylene glycol, propylene glycol alginate, pectin, methoxyl pectin, guar gum, gum arabic, carrageenan, methylcellulose, xanthan gum and hydroxypropylcellulose.

9. An aqueous pharmaceutical composition according to claim 7, wherein said water-soluble polymer substance is polyethylene glycol.

10. An aqueous pharmaceutical composition according to claim 7, wherein said water-soluble polymer substance is hydroxypropylcellulose.

11. An aqueous pharmaceutical composition according to claim 1, wherein the ciclesonide particles have a size of between about 10 nm and about 100 .mu.m.

12. An aqueous pharmaceutical composition according to claim 1, wherein the ciclesonide particles have a size of between about 10 nm and about 10 .mu.m.

13. An aqueous pharmaceutical composition according to claim 1, further comprising at least one wetting agent.

14. An aqueous pharmaceutical composition according to claim 13, wherein at least one wetting agent present is selected from the group consisting of Polysorbate 80, glycerin monostearate, polyoxyl stearate, lauromacrogol, sorbitan oleate and sucrose fatty acid esters.

15. An aqueous pharmaceutical composition according to claim 1, further comprising at least one osmotic-pressure controlling agent.

16. An aqueous pharmaceutical composition according to claim 15, wherein at least one osmotic-pressure controlling agent present is a salt.

17. An aqueous pharmaceutical composition according to claim 16, wherein the salt is sodium chloride.

18. An aqueous pharmaceutical composition according to claim 15, wherein at least one osmotic-pressure controlling agent present is a water-soluble sugar.

19. An aqueous pharmaceutical composition according to claim 18, wherein the water-soluble sugar is glucose.

20. An aqueous pharmaceutical composition according to claim 1, wherein the ciclesonide is present in a concentration of between about 0.01% w/w and about 1% w/w, relative to the total amount of the composition.

21. An aqueous pharmaceutical composition according to claim 1, wherein the ciclesonide is present in a concentration of between about 0.05% w/w and about 0.5% w/w, relative to the total amount of the composition.

22. An aqueous pharmaceutical composition according to claim 1, further comprising at least one antiseptic.

23. An aqueous pharmaceutical composition according to claim 22, wherein at least one antiseptic present is benzalkonium chloride.

24. An aqueous pharmaceutical composition according to claim 1, further comprising at least one pH controlling agent.

25. An aqueous pharmaceutical composition according to claim 24, wherein at least one pH controlling agent present is selected from the group consisting of hydrochloric acid and sodium hydroxide.

26. An aqueous pharmaceutical composition according to claim 1, further comprising at least one preservative.

27. An aqueous pharmaceutical composition according to claim 26, wherein at least one preservative present is ascorbic acid.

28. An aqueous pharmaceutical composition according to claim 1, further comprising at least one buffer.

29. An aqueous pharmaceutical composition according to claim 28, wherein at least one buffer present is selected from the group consisting of phosphoric acid and salts thereof.

30. An aqueous pharmaceutical composition according to claim 1, further comprising (a) at least one pH controlling agent, and (b) at least one antiseptic or at least one preservative.

31. An aqueous pharmaceutical composition according to claim 24, wherein the at least one pH controlling agent is hydrochloric acid.
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