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1. (WO2019046844) COMPOSITIONS PHARMACEUTIQUES FORMANT IN SITU UN GEL ET LEURS UTILISATIONS POUR DES MALADIES DES SINUS
Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

WHAT IS CLAIMED IS:

1. An aqueous pharmaceutical composition comprising an antiseptic, a steroid, and a biocompatible polysaccharide, wherein the composition can form a gel in situ upon instillation into a sinonasal cavity of a subject in need thereof.

2. The aqueous pharmaceutical composition of claim 1, wherein the antiseptic comprises povidone-iodine (PVP-I) or chlorhexidine.

3. The aqueous pharmaceutical composition of claim 1 or 2, wherein the antiseptic is contained in the composition at a concentration of 0.1% to 5.0% (weight/weight or weight/volume).

4. The aqueous pharmaceutical composition of any of claims 1-3, wherein the antiseptic is contained in the composition at a concentration of 0.2% to 1.0% (weight/weight or weight/volume).

5. The aqueous pharmaceutical composition of claim 1, wherein the antiseptic comprises povidone-iodine (PVP-I).

6. The aqueous pharmaceutical composition of claim 1, wherein the steroid comprises mometasone, fluticasone, or budesonide, or a salt, an ester, or any combination thereof.

7. The aqueous pharmaceutical composition of claim 1, wherein the steroid comprises fluticasone or budesonide, or a salt, an ester, or any combination thereof.

8. The aqueous pharmaceutical composition of claim 1, wherein the polysaccharide comprises deacetylated gellan gum (DGG), xanthan, sodium alginate, carrageenan, or any mixture thereof.

9. The aqueous pharmaceutical composition of claim 1, wherein the polysaccharide is contained in the composition at a concentration of 0.1% to 2.0% (weight/weight or weight/volume).

10. The aqueous pharmaceutical composition of claim 1 or 9, wherein the polysaccharide is contained in the composition at a concentration of 0.1% to 0.5% (weight/weight).

11. The aqueous pharmaceutical composition of claim 1, wherein the polysaccharide comprises deacetylated gellan gum (DGG).

12. The aqueous pharmaceutical composition of claim 1, further comprises an osmotic pressure regulator, a surfactant, a viscosity increasing agent, a pH regulator, or a cooling agent.

13. The aqueous pharmaceutical composition of claim 12, wherein the osmotic pressure regulator comprises sodium chloride, glycerol, polyethylene glycol 400 (PEG400), mannitol, or boric acid.

14. The aqueous pharmaceutical composition of claim 13, wherein the osmotic pressure regulator is contained in the composition at a concentration of 0.1 to 0.5% (weight/volume).

15. The aqueous pharmaceutical composition of claim 12, wherein the surfactant comprises polysorbate-20, polysorbate-60, polysorbate-80, polyoxyethylene surfactant, polyxoypropylene surfactant, cyclodextrin, tyloxapol, PEG 35 Caster oil, glycerin, or polyoxyl 40 Strerate.

16. The aqueous pharmaceutical composition of claim 15, wherein the surfactant is contained in the composition at a concentration of 0.01%-2% (weight/weight).

17. The aqueous pharmaceutical composition of claim 12, wherein the viscosity increasing agent comprises polyvinyl alcohol, polyvinylpyrrolidone, methyl cellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose, carboxymethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, carboxymethyl cellulose sodium, or dextrose anhydrous.

18. The aqueous pharmaceutical composition of claim 17, wherein the viscosity agent is contained in the composition at a concentration of 0.01%-2% (weight/weight).

19. The aqueous pharmaceutical composition of claim 12, wherein the cooling agent comprises a menthol, a methone glycerin acetyl, a menthyl ester, a carboxamide, a menthane glycerol ketal, an alkyl substituted urea, a sulfonamide, a terpene analogs franone, a phosphine oxide, a derivative thereof, a camphor, or a bonel.

20. The aqueous pharmaceutical composition of claim 12, wherein the pH regulator comprises sodium hydroxide, tris(hydroxymethyl)aminomethane (Tris), phosphoric acid, or any mixture thereof.

21. The aqueous pharmaceutical composition of any of claims 1-20, wherein the

composition has a pH value in the range of 4.0 to 7.0.

22. The aqueous pharmaceutical composition of any of claims 1-21, wherein the composition has a pH value in the range of 4.0 to 6.0.

23. The aqueous pharmaceutical composition of claim 1, further comprises an anesthetic agent.

24. The aqueous pharmaceutical composition of claim 1, wherein the composition is in the form of a solution, a suspension, or an emulsion.

25. The aqueous pharmaceutical composition of claim 24, wherein the solution is a gel forming aqueous solution, or gel forming suspension.

26. The aqueous pharmaceutical composition of claim 1, wherein water is added to form a solution ready for use in irrigation or spraying into the sinal cavity of the subject.

27. A method for treating a clinical sinus symptom of the airway of a subject in need thereof, comprising administering to a sinal cavity of the patient an aqueous pharmaceutical composition comprising an antiseptic, a steroid, and a biocompatible polysaccharide, wherein the composition can form a gel in situ upon instillation into the sinal cavity.

28. The method of claim 27, wherein the sinus symptom is inflammation, infection, formation of biofilm, rhinosinusitis, congestion, pain, pressure, fatigue, or thickened nasal discharge.

29. The method of claim 27, wherein the airway is sinus, nose, or lung.

30. The method of claim 27, wherein the pharmaceutical composition is administered to the subject by a rinsing bottle, metered-dose, manual-pump spray, a metering, or an atomizing spray pump.

31. The method of claim 27, wherein the antiseptic comprises povidone-iodine, and the steroid comprises budesonide, micronized fluticasone proprionate, or micronized mometasone.

32. The method of claim 27, wherein the dose volume of the antiseptic administered to the subject is between about 10 meg to about 300 meg per day, about 20 meg to about 200 meg per day, about 30 meg to about 100 meg per day, or about 50 meg per day with two sprays per nostril per day.

33. A method for improving the lung condition of a cystic fibrosis patient, comprising washing the sinal cavity of the patient with an aqueous pharmaceutical composition comprising an antiseptic, a steroid, and a biocompatible polysaccharide, wherein the composition can form a gel in situ upon instillation into the sinal cavity.

34. The method of claim 33, wherein the antiseptic comprises povidone-iodine (PVP-I).

35. The method of claim 33, wherein the steroid comprises micronized budesonide, micronized fluticasone proprionate, or micronized mometasone.