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Claims for Patent: 6,858,596

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Claims for Patent: 6,858,596

Title: Formulation containing anti-inflammatory androstane derivative
Abstract:There is provided a pharmaceutical formulation comprising an aqueous suspension of particulate compound of formula (I) ##STR1## or a solvate thereof.
Inventor(s): Biggadike; Keith (Stevenage, GB), Sayani; Amyn Pyarali (Mississauga, CA), Buxton; Ian Richard (Mississauga, CA), Reed; Kenton Lewis (Mississauga, CA)
Assignee: SmithKline Beecham Corporation (Philadelphia, PA)
Application Number:10/067,020
Patent Claims: 1. A pharmaceutical formulation which comprises: an aqueous suspension of particulate compound of formula (I) ##STR8##

or a solvate thereof.

2. A pharmaceutical formulation according to claim 1 which comprises: one or more suspending agents.

3. A pharmaceutical formulation according to claim 2 wherein the suspending agent is microcrystalline cellulose and carboxy methylcellulose sodium.

4. A pharmaceutical formulation according to claim 2 wherein the suspending agent is present in an amount of between 0.1 and 5% (w/w), based on the total weight of the formulation.

5. A pharmaceutical formulation according to claim 1 which comprises: one or more preservatives.

6. A pharmaceutical formulation according to claim 5 wherein the preservative comprises benzalkonium chloride.

7. A pharmaceutical formulation according to claim 6 wherein the benzalkonium chloride is present within the formulation in an amount of between 0.001 and 1% (w/w), based on the total weight of the formulation.

8. A pharmaceutical formulation according to claim 5 wherein the preservative comprises EDTA.

9. A pharmaceutical formulation according to claim 6 wherein the preservative also comprises EDTA.

10. A pharmaceutical formulation according to any claim 1 which comprises: one or more wetting agents.

11. A pharmaceutical formulation according to claim 10 wherein the wetting agent comprises polyoxyethylene (20) sorbitan monooleate.

12. A pharmaceutical formulation according to claim 11 wherein the polyoxyethylene (20) sorbitan monooleate is present within the formulation in an amount of between 0.001 and 0.05% (w/w), based on the total weight of the formulation.

13. A pharmaceutical formulation according to claim 1 which comprises: one or more isotonicity adjusting agents.

14. A pharmaceutical formulation according to claim 13 wherein the isotonicity adjusting agent comprises dextrose.

15. A pharmaceutical formulation according to claim 14 wherein dextrose is present within the formulation in an amount of between 0.1 and 10% (w/w), based on the total weight of the formulation.

16. A pharmaceutical formulation according to claim 1 characterised in that it is isotonic with fluids of the nasal cavity.

17. A pharmaceutical formulation to claim 1 which is buffered to a pH of between 5 and 7.

18. A pharmaceutical formulation according to claim 17 which is buffered using hydrochloric acid.

19. A pharmaceutical formulation according to claim 1 wherein the compound of formula (I) or solvate thereof is present within the formulation in an amount between 0.005% and 1% (w/w), based on the total weight of the formulation.

20. A pharmaceutical formulation according to claim 1 wherein the compound of formula (I) is used as unsolvated polymorph Form 1.

21. A pharmaceutical formulation according to claim 1 which comprises (i) one or more suspending agents; (ii) one or more preservatives; (iii) one or more wetting agents; and

one or more isotonicity adjusting agents.

22. A pharmaceutical formulation according to claim 21 wherein the suspending agent is microcrystalline cellulose and carboxy methylcellulose sodium, the preservative is EDTA and benzalkonium chloride, the wetting agent is polyoxyethylene (20) sorbitan monooleate and the isotonicity adjusting agent is dextrose.

23. A container comprising a pharmaceutical formulation according to claim 1 suitable for delivering it in the form of a nasal spray.

24. A method of treatment of allergic rhinitis which comprises administering to a patient a pharmaceutically acceptable amount of a formulation according to claim 1.

25. The method according to claim 24 wherein the administration is once-per-day.

26. The pharmaceutical formulation according to claim 1, wherein the particulate compound of formula (I) or solvate thereof is present within the formulation, in an amount which is between 0.01% and 0.5% (w/w) based on the total weight of the formulation.

27. The pharmaceutical formulation according to claim 2, wherein the suspending agent is selected from the group consisting of carboxymethylcellulose, veegum, tragacanth, bentonite, methylcellulose and polyethylene glycol.

28. The pharmaceutical formulation according to claim 5, wherein the one or more preservatives are selected from the group consisting of quaternary ammionium compounds, mercurial agents, alcoholic agents, antibacterial esters, chelating agents, chlorhexidine, chlorocresol, sorbic acid and its salts and polymyxin.

29. The pharmaceutical formulation according to claim 28, wherein the quaternary ammonium compounds are selected from the group consisting of benzalkonium chloride, benzethonium chloride, cetrimide and cetylpyridinium chloride, the mercurial agents are selected from the group consisting of phenylmercuric nitrate, phenylmercuric acetate and thimerosal, the alcoholic agents are selected from the group consisting of chlorobutanol, phenylethyl alcohol and benzyl alcohol, the antibacterial esters are esters of para-hydroxybenzoic acid, or the chelating agent is disodium edetate (EDTA).

30. The pharmaceutical formulation according to claim 1, which further comprises a pharmaceutically acceptable wetting agent selected from the group consisting of fatty alcohols, esters and ethers.

31. The pharmaceutical formulation according to claim 13, wherein the isotonicity adjusting agent is selected from the group consisting of sodium chloride, dextrose and calcium chloride.

32. The pharmaceutical formulation according to claim 1, which further comprises another therapeutically active agent.

33. The pharmaceutical formulation according to claim 32, wherein said another therapeutically active agent is a PDE4 inhibitor.

34. The pharmaceutical formulation according to claim 32, wherein said another therapeutically active agent is an anti-histamine, anti-inflammatory agent or antiinfective agent.

35. The pharmaceutical formulation according to claim 34, wherein said anti-histamine is methapyrilene or loratadine, said anti-inflammatory agent is an NSAID and said antiinfective agent is an antibiotic or antiviral.

36. A method for the treatment of at least one condition selected from the group consisting of rhinitis, dermatitis, asthma and chronic obstructive pulmonary disease (COPD) in a human or animal subject, which comprises administering an effective amount of the pharmaceutical formulation as defined in claim 1 to said human or animal subject in need thereof for the treatment of said at least one condition.

37. The method of treatment as recited in claim 36, wherein said composition is administered by inhalation or by nebulisation.

38. The method according to claim 36 wherein administration is nasally.

39. An inhaler comprising the pharmaceutical formulation as defined in claim 1.
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