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1. WO2007140285 - NEBULIZABLE COMPOSITIONS OF QUATERNARY AMMONIUM MUSCARINIC RECEPTOR ANTAGONISTS

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[ EN ]

CLAIMS

What is claimed is:
1. A kit for the treatment, prevention or amelioration or one or more symptoms of diseases or disorders associated with bronchoconstriction which comprises:
(i) a nebulizer;
(ii) a nebulizable composition for the treatment, prevention or amelioration or one or more symptoms of diseases or disorders associated with bronchoconstriction which comprises:
(a) a quaternary ammonium muscarinic receptor antagonist in a concentration based on the ammonium of between about 0.0005% and about 5% by weight;
(b) a pharmacologically acceptable fluid; and
(c) a pharmacologically acceptable preservative,
wherein the pH of the preparation is adjusted between about 2.0 to about 4.5 with an acid and the quaternary ammonium muscarinic receptor antagonist is dissolved in the fluid and optional includes pharmacologically acceptable complexing agent, stabilizer, a pharmacologically acceptable cosolvent, or other
pharmacologically acceptable adjuvants and additives; and
(iii) packaging material which include instructions for the administration of the nebulizable composition to a patient in need of treatment, prevention or amelioration or one or more symptoms of diseases or disorders associated with
bronchoconstriction;
wherein the administration of the nebulizable composition by the nebulizer results in minimal exposure of the nebulized composition to the body surface of the patient.

2. The kit of claim 1 , wherein the body surface of the patient is the face and eyes.

3. The kit of claim 2, wherein the loss of quaternary ammonium muscarinic receptor antagonists delivered to the mouth and lungs of the patient is less than

0.001% w/w.

4. The kit of claim 3, wherein the nebulizer releases the nebulized composition upon inhalation by the patient and ceases release of the nebulized composition when inhalation is stopped.

5. The kit of claim 4, wherein the nebulizer is a breath actuated nebulizer.

6. The kit of claim 5, wherein the quaternary ammonium muscarinic receptor antagonist is an ipratropium or tiotropium compound.

7. The kit of claim 6, wherein the tiotropium compound is tiotropium bromide.

8. The kit of claim 7, wherein the nebulizable composition further comprises an additional compound for the treatment of bronchostriction which is selected from the group consisting of a β2-adrenoreceptor agonist, a dopamine (D2) receptor agonist, a steroidal anti-inflammatory agent, an anticholinergic agent, an IL- 5 inhibitor, an antisense modulator of IL-5, a tryptase inhibitor, a leukotriene receptor antagonist, a 5-lapoxygenase inhibitor, an anti-IgE antibody, an antihistamine, an anti-allergic agent and mixtures thereof.

9. The kit of claim 7, wherein the nebulizable composition is contained in a unit dose vial.

10. The kit of claim 1, wherein the instructions recite once a day prior to going to sleep administration of the nebulizable composition.

I L A method of treating, preventing or ameliorating one or more symptoms of a disease or disorder associated with bronchoconstriction which comprises, delivering the nebulizable composition via the nebulizer from the kit of claim 1, wherein the administration of the nebulizable composition by the nebulizer results in minimal exposure of the nebulized composition to the body surface of the patient.

12. The method of claim 11 , wherein the body surface of the patient is the face and eyes.

13. The method of claim 12, wherein the loss of quaternary ammonium
muscarinic receptor antagonists delivered to the mouth and lungs of the patient is less than 0.001% w/w.

14. The method of claim 13, wherein the nebulizer allows for the release of the nebulized composition upon inhalation by the patient and ceases release of the nebulized composition when inhalation has ended.

15. The method of claim 14, wherein the nebulizer is a breath actuated nebulizer.

16. The method of claim 15, wherein the quaternary ammonium muscarinic receptor antagonist is an ipratropium or tiotropium compound.

17. The method of claim 16, wherein the tiotropium compound is tiotropium bromide.

18. The method of claim 17, wherein the nebulizable composition further comprises an additional compound for the treatment of bronchostriction which is selected from the group consisting of a β2-adrenoreceptor agonist, a dopamine (D2) receptor agonist, a steroidal anti-inflammatory agent, an anticholinergic agent, an IL-5 inhibitor, an antisense modulator of IL-5, a tryptase inhibitor, a leukotriene receptor antagonist, a 5-lapoxygenase inhibitor, an anti-IgE antibody, an antihistamine, an antiallergic agent and mixtures thereof.

19. The method of claim 17, wherein the nebulizable composition is contained in a unit dose vial.

20. The method of claim 17, wherein the nebulizable composition is administered once a day administration prior to the patient going to sleep.