Systems and methods for the delivery of corticosteroids
AssigneeVerus Pharmaceuticals, Inc.
InventorMalcolm Hill
Life of this patent
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Abstract
The present invention relates to methods and systems for the delivery of a corticosteroid comprising (1) an inhalable aqueous mixture comprising a corticosteroid and a solubility enhancer and (2) an inhalable nebulizer, wherein the delivery of the aqueous mixture comprising the corticosteroid by the nebulizer results in an enhanced pharmacokinetic profile of the corticosteroid as compared to conventional inhalable therapies and/or increase lung deposition.
Claims104
An inhalable composition comprising about 250 μg or less of a single corticosteroid, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a device, the composition achieves a rate of increasing concentration of the corticosteroid inside the device of about 5 μg/ml per minute or less over administration of the corticosteroid through the device, and wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid.
An inhalable composition comprising an effective amount of a single corticosteroid, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a device, the composition achieves a rate of increasing concentration of the corticosteroid inside the device of 60% or less of a rate of increasing concentration of the corticosteroid inside the device achieved by an inhalable suspension comprising the corticosteroid without a solubility enhancer administered under the same conditions, and wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid.
A method of generating fine particles from an inhalable composition comprising:
- forming the composition by adding a solvent and a solubility enhancer to an effective amount of a single corticosteroid, wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid;
- and
- operating a nebulizer to produce fine particles of the composition,
- wherein upon administration of the composition to a subject through the nebulizer, the composition achieves a rate of increasing concentration of the corticosteroid inside the nebulizer of 60% or less of a rate of increasing concentration of the corticosteroid inside the nebulizer achieved by an inhalable suspension comprising the corticosteroid without a solubility enhancer administered under the same conditions.
An inhalation system for delivering a therapeutically effective dose of a single corticosteroid to a patient comprising:
- (a) an aqueous inhalation mixture comprising the corticosteroid, a solvent and a solubility enhancer, wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid and
- (b) a nebulizer
- wherein upon administration of the mixture to a subject through the nebulizer, the mixture achieves a rate of increasing concentration of the corticosteroid inside the nebulizer of 60% or less of a rate of increasing concentration of the corticosteroid inside the nebulizer achieved by an inhalable suspension comprising the corticosteroid without a solubility enhancer administered under the same conditions.
A method for the treatment of a bronchoconstrictive disorder in a patient in need of treatment thereof, comprising:
- forming a composition by adding a solvent and a solubility enhancer to an amount of a single corticosteroid, wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid;
- and
- operating a nebulizer,
- wherein upon administration of the composition to a subject through the nebulizer, the composition achieves a rate of increasing concentration of the corticosteroid inside the nebulizer of 60% or less of a rate of increasing concentration of the corticosteroid inside the nebulizer achieved by an inhalable suspension comprising the corticosteroid without a solubility enhancer administered under the same conditions.
An inhalable composition comprising about 250 μg or less of budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a device, the composition achieves a rate of increasing concentration of budesonide inside the device of about 5 μg/ml per minute or less over administration of the budesonide through the device, and wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid.
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 device, the composition achieves a rate of increasing concentration of budesonide inside the device of 60% or less of a rate of increasing concentration of budesonide inside the device achieved by an inhalable suspension comprising budesonide without a solubility enhancer administered under the same conditions, and wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid.
A method of generating fine particles from an inhalable composition comprising:
- forming the composition by adding a solubility enhancer to an effective amount of budesonide, wherein the composition is substantially free of active pharmaceutical agents other than the budesonide;
- and
- operating a nebulizer to produce fine particles of the composition,
- wherein upon administration of the composition to a subject through the nebulizer, the composition achieves a rate of increasing concentration of budesonide inside the nebulizer of 60% or less of a rate of increasing concentration of budesonide inside the nebulizer achieved by an inhalable suspension comprising budesonide without a solubility enhancer administered under the same conditions.
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, wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid;
- and
- (b) a nebulizer
- wherein upon administration of the mixture to a subject through the nebulizer, the mixture achieves a rate of increasing concentration of budesonide inside the nebulizer of 60% or less of a rate of increasing concentration of budesonide inside the nebulizer achieved by an inhalable suspension comprising budesonide without a solubility enhancer administered under the same conditions.
A method for the treatment of a bronchoconstrictive disorder in a patient in need of treatment thereof, comprising:
- forming a composition by adding a solubility enhancer to an amount of budesonide, wherein the composition is substantially free of active pharmaceutical agents other than the budesonide;
- and
- operating a nebulizer,
- wherein upon administration of the composition to a subject through the nebulizer, the composition achieves a rate of increasing concentration of budesonide inside the nebulizer of 60% or less of a rate of increasing concentration of budesonide inside the nebulizer achieved by an inhalable suspension comprising budesonide without a solubility enhancer administered under the same conditions.
Dependencies are inferred from the claim text.