Combination of levocabastine and fluticasone furoate for the treatment of inflammatory and/or allergic conditions
The present invention relates to pharmaceutical formulations comprising an anti-inflammatory glucocorticoid compound of the androstane series and levocabastine, an H 1 antagonist/anti-allergic, and also relates to therapeutic uses thereof, particularly for the treatment of inflammatory and allergic conditions, specifically rhinitis.
1. A pharmaceutical formulation comprising levocabastine
or a salt thereof
and fluticasone furoate.
2. A pharmaceutical formulation according to claim 1 , comprising levocabastine hydrochloride and fluticasone furoate.
3. A pharmaceutical formulation according to claim 1 , wherein fluticasone furoate and levocabastine or salt thereof are present in the form of suspended particles.
4. A pharmaceutical formulation according to claim 1 , which is an aqueous pharmaceutical formulation.
5. A pharmaceutical formulation according to claim 1 , which is suitable for intranasal delivery.
6. A pharmaceutical formulation according to claim 1 , which further comprises one or more suspending agents.
7. A pharmaceutical formulation according to claim 1 , which comprises one or more preservatives.
8. A pharmaceutical formulation according to claim 1 , which comprises one or more wetting agents.
9. A pharmaceutical formulation according to claim 1 , which comprises one or more isotonicity adjusting agents.
10. A pharmaceutical formulation according to claim 9 , characterised in that it is isotonic with fluids of the nasal cavity.
11. A pharmaceutical formulation according to claim 1 , which comprises a buffer.
12. A pharmaceutical formulation according to claim 4 , which is pH adjusted to between 6 and 8.
13. A pharmaceutical formulation according to claim 1 , which comprises one or more taste-masking agents.
14. A pharmaceutical formulation according to claim 1 , wherein fluticasone furoate is present within the formulation in an amount of from 0.005% to 1% (w/w), based on the total weight of the formulation.
15. A pharmaceutical formulation according to claim 1 , wherein levocabastine or a salt thereof is present within the formulation in an amount of from 0.0005% to 2% (w/w), based on the total weight of the formulation.
16. A pharmaceutical formulation according to claim 1 , which comprises
(i) an aqueous suspension of levocabastine or a salt thereof;
(ii) an aqueous suspension of fluticasone furoate;
(iii) one or more suspending agents;
(iv) one or more preservatives;
(v) one or more wetting agents;
(vi) a buffer;
(vii) one or more isotonicity adjusting agents; and optionally
(viii) one or more taste-masking agents.
17. A device adapted for intranasal delivery of a pharmaceutical formulation comprising a pharmaceutical formulation as claimed in claim 1 .
18. A method of treatment of allergic rhinitis which comprises administering to a patient a pharmaceutically acceptable amount of a pharmaceutical formulation according to claim 1 .
19. The method according to claim 18 , wherein the administration is once-per-day.
20. A method for the treatment of a human subject with an inflammatory and/or allergic condition, which method comprises administering to said human subject an effective amount of a pharmaceutical formulation according to claim 1 .