Corticosteroid particles and method of production

Abstract

A new particle morphology of glucocorticosteroids is described. The forms have a particle morphology that is particularly well suited for use in an inhaled corticosteroid drug suspension formulation for delivery from a next generation nebulizer device. Use of the new glucocorticosteroid particles enables enhanced drug delivery efficiency and increased residence time of the delivered drug in the lungs. New methods for producing glucocorticosteroid particles having these specific particle morphologies are also described. The methods provide a simplified, reproducible and scalable particle formation process that can produce glucocorticosteroid particles having a narrow particle size and shape distribution, a low surface energy, a low aspect ratio, uniform particle morphology and a reduced specific surface area.

What is claimed is: 
     
         1 . A pharmaceutical formulation comprising budesonide particles comprising:
 crystalline particles of budesonide having a particle size distribution with mean diameter of 1 micron to 10 microns;   the particles further having a specific surface area of between 1 m 2 /g and 3 m 2 /g; and the particles have a square bifrustum morphology with a mean largest dimension of less than 4 microns and a mean aspect ratio of less than 2.0;   
       wherein the formulation is suitable for administration to a patient using a nebulizer. 
     
     
         2 . The pharmaceutical formulation of  claim 1 , wherein the nebulizer is a next generation nebulizer. 
     
     
         3 . The pharmaceutical formulation of  claim 1 , wherein the formulation further comprises a dispersion enhancer. 
     
     
         4 . The pharmaceutical formulation of  claim 1 , wherein the formulation further comprises a pharmaceutically accepted excipient. 
     
     
         5 . A method of treating one or more respiratory condition comprising administering to a subject in need thereof a therapeutically effective amount of the pharmaceutical formulation of  claim 1 . 
     
     
         6 . The method of  claim 5  wherein the one or more respiratory condition is selected from the group consisting of asthma, chronic obstructive pulmonary disease (COPD), respiratory distress syndrome, chronic cough and bronchiolitis. 
     
     
         7 . The method of  claim 5 , wherein the nebulizer is a next generation nebulizer. 
     
     
         8 . The method of  claim 5 , wherein the subject is an adult patient. 
     
     
         9 . The method of  claim 5 , wherein the subject is a pediatric patient.