Methods and systems for the delivery of corticosteroids having an increased lung depositon

A method of generating fine particles from an inhalable composition comprising:

• (a) adding a solvent and a solubility enhancer to an effective amount of corticosteroid, and
• (b) operating a nebulizer to produce fine particles of said composition, wherein upon administration of the composition to a subject through the nebulizer, the method achieves at least about 35% lung deposition based on the amount of corticosteroid in the composition prior to administration.

An inhalation system for delivering a therapeutically effective dose of a corticosteroid to a patient comprising:

• (a) an aqueous inhalation mixture comprising the corticosteroid and a solubility enhancer, and
• (b) a nebulizer
• whereby upon administration of the composition to a subject through said nebulizer, the system achieves at least about 35% lung deposition based on the amount of corticosteroid in the mixture prior to administration.

A method for the treatment of a bronchoconstrictive disorder in a patient in need of treatment thereof, comprising:

• forming a mixture by adding a solvent and a solubility enhancer to an amount of corticosteroid and operating a nebulizer,
• wherein upon administration of the mixture to a subject through the nebulizer, the method achieves at least about 35% lung deposition based on the amount of corticosteroid in the mixture prior to administration.

An inhalable composition comprising an effective amount of budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves at least about 35% lung deposition based on the amount of budesonide in the composition prior to administration.

An inhalable composition comprising about 60 μg budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves lung deposition of at least 20 μg of budesonide.

An inhalable composition comprising about 120 μg budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves lung deposition of at least 40 μg of budesonide.

An inhalable composition comprising about 240 μg budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves lung deposition of at least 80 μg of budesonide.

A method of generating fine particles from an inhalable composition comprising:

• adding a solvent and a solubility enhancer to an effective amount of budesonide, and
• operating a nebulizer to produce fine particles of said composition,
• wherein upon administration of the composition to a subject through the nebulizer, the method achieves at least about 35% lung deposition based on the amount of budesonide in the composition prior to administration.

An inhalation system for delivering a therapeutically effective dose of budesonide to a patient comprising:

• (a) an aqueous inhalation mixture comprising budesonide and a solubility enhancer, and
• (b) a nebulizer
• whereby upon administration of the composition to a subject through said nebulizer, the system achieves at least about 35% lung deposition based on the amount of budesonide in the mixture prior to administration.

A method for the treatment of a bronchoconstrictive disorder in a patient in need of treatment thereof, comprising:

• forming a mixture by adding a solvent and a solubility enhancer to an amount of budesonide and
• operating a nebulizer,
• wherein upon administration of the mixture to a subject through the nebulizer, the method achieves at least about 35% lung deposition based on the amount of budesonide in the mixture prior to administration.