Aerosol Composition for Administering Drugs
AssigneeMAP Pharmaceuticals, Inc.
InventorsLibo WU, Wiwik WATANABE
Life of this patent
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Abstract
Described here are compositions and methods for the treatment of respiratory conditions using glucocorticosteroids delivered by a next generation nebulizer. The methods administer a therapeutic dose with nebulization time of 2 minutes or less. The faster nebulization time improves patient compliance.
Claims20
An aqueous dispersion or suspension of a drug wherein when a therapeutic dose is administered by a next generation nebulizer to generate an inhaled aerosol composition:
- said aerosol composition comprises drug particles having a mean diameter from about 1 micron to about 3 microns;
- said aerosol composition has a fine particle fraction of at least about 25%;
- the nebulization time is in the range of about 15 seconds to about 120 seconds;
- and
- about 39% or less of the drug particles are retained on the mesh after the nebulization time.
A therapeutic dose comprising an aqueous dispersion or suspension of budesonide particles, wherein:
- said aqueous dispersion or suspension comprises polysorbate 80 at a concentration in range of about 120 micrograms per milliliter to about 130 micrograms per milliliter;
- said budesonide particles have a mean diameter from about 1 microns to about 3 microns;
- said therapeutic dose is administered by a next generation nebulizer to generate an inhaled aerosol composition;
- wherein
- said aerosol composition has a fine particle fraction is at least 25%;
- said therapeutic dose can be administered a period of about 15 seconds to about 120 seconds;
- and
- wherein 39% or less of the budesonide particles retained on the mesh of the nebulizer.
A method of treating a patient having a respiratory disorder comprising the steps of:
- forming an aerosol composition by introducing into a next generation nebulizer a predetermined volume of a drug formulation comprising a dispersion or suspension of glucocorticosteroid particles;
- said aerosol composition comprising a dispersion enhancer;
- said glucocorticosteroid particles having a mean diameter from about 1 micron about 3 microns;
- and the said aerosol composition has a fine particle fraction is at least 25%;
- said predetermined volume of said dispersion or suspension of glucocorticosteroids is delivered by the next generation nebulizer in about 120 seconds or less;
- and
- wherein 40% or less of the therapeutic particles are retained on the mesh after predetermined volume has been delivered.
Dependencies are inferred from the claim text.