Formulations and methods for treating rhinosinusitis
AssigneeDey Pharma, L.P.
InventorImtiaz Chaudry
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Abstract
The invention involves methods and formulations for treating or preventing rhinosinusitis, including fungus-induced rhinosinusitis in mammals. In one embodiment, the formulation of the present invention comprises a steroidal anti-inflammatory agent having a specific particle size distribution profile. The formulation may also comprise an antifungal agent, antibiotic or antiviral agent.
Claims20
A formulation for the treatment of fungus-induced rhinosinusitis in a mammal, comprising an aqueous suspension of a steroidal anti-inflammatory, said formulation comprising:
- a) a therapeutically effective amount of the steroidal anti-inflammatory having the following particle size distribution profile:
- i. about 10% of the steroidal anti-inflammatory particles have a particle size of less than 0.90 microns;
- ii. about 25% of the steroidal anti-inflammatory particles have a particle size of less than 1.6 microns;
- iii. about 50% of the steroidal anti-inflammatory particles have a particle size of less than 3.2 microns;
- iv. about 75% of the steroidal anti-inflammatory particles have a particle size of less than 6.2 microns;
- and
- v. about 90% of the steroidal anti-inflammatory particles have a particle size of less than 10.0 microns;
- and
- b) an antifungal agent, wherein the amount of the antifungal agent is from about 0.5 to 150 mg.
A nasal spray formulation comprising:
- an aqueous suspension having
- a) about 0.005% to about 5% by weight of a steroidal anti-inflammatory, the steroidal anti-inflammatory comprising fluticasone, beclomethasone, or combination thereof having the following particle size distribution profile:
- i. about 10% of the steroidal anti-inflammatory particles have a particle size of less than 0.90 microns;
- ii. about 25% of the steroidal anti-inflammatory particles have a particle size of less than 1.6 microns;
- iii. about 50% of the steroidal anti-inflammatory particles have a particle size of less than 3.2 microns;
- iv. about 75% of the steroidal anti-inflammatory particles have a particle size of less than 6.2 microns;
- and
- v. about 90% of the steroidal anti-inflammatory particles have a particle size of less than 10.0 microns;
- and
- b) an antifungal agent, wherein the amount of the antifungal agent is from about 0.5 to 150 mg.
A method of treating fungus-induced rhinosinusitis in a mammal, said method comprising the steps of applying to the mammal's nasal-paranasal mucosa a formulation comprising:
- a) a therapeutically effective amount of a steroidal anti-inflammatory having the following particle size distribution profile:
- i. about 10% of the steroidal anti-inflammatory particles have a particle size of less than 0.90 microns;
- ii. about 25% of the steroidal anti-inflammatory particles have a particle size of less than 1.6 microns;
- iii. about 50% of the steroidal anti-inflammatory particles have a particle size of less than 3.2 microns;
- iv. about 75% of the steroidal anti-inflammatory particles have a particle size of less than 6.2 microns;
- and
- v. about 90% of the steroidal anti-inflammatory particles have a particle size of less than 10.0 microns;
- and
- b) an antifungal agent, wherein the amount of the antifungal agent is from about 0.5 to 150 mg.
The method of claim 27, wherein the steroidal anti-inflammatory comprises beclomethasone having the following particle size distribution profile:
- i. about 10% of the steroidal anti-inflammatory particles have a particle size of less than 0.3 microns;
- ii. about 25% of the steroidal anti-inflammatory particles have a particle size of less than 0.55 microns;
- iii. about 50% of the steroidal anti-inflammatory particles have a particle size of less than 1.2 microns;
- iv. about 75% of the steroidal anti-inflammatory particles have a particle size of less than 1.8 microns;
- and
- v. about 90% of the steroidal anti-inflammatory particles have a particle size of less than 2.7 microns.
Dependencies are inferred from the claim text.