Method and apparatus for producing dry particles

Abstract

Method and apparatus for producing dry particles. Two liquid components are combined in a static mixer, atomized into droplets, and the droplets dried to form dry particles. Use of the static mixer enables incompatible liquid components to be rapidly and homogeneously combined. The present invention optimizes process conditions for increasing and controlling particle porosity. The present invention also allows for optimization of particle size in real-time during particle production.

1 . A method for preparing a dry powder composition, comprising: 
 combining a hydrophobic component and a hydrophilic component in a static mixer to form a combination, wherein one of the hydrophilic component and the hydrophobic component comprises an active agent;    atomizing the combination flowing out of the static mixer to produce droplets; and    drying the droplets to form dry particles.    
     
     
         2 . The method of  claim 1 , wherein the hydrophilic component comprises an active agent.  
     
     
         3 . The method of  claim 1 , wherein the hydrophobic component comprises an excipient.  
     
     
         4 . The method of  claim 2 , wherein the hydrophobic component comprises an excipient.  
     
     
         5 . The method of  claim 2  or  4 , wherein the active agent is selected from the group consisting of insulin, albuterol sulfate, L-DOPA, humanized monoclonal antibody (Ig G1), human growth hormone, epinephrine, and salmeterol xinafoate.  
     
     
         6 . The method of  claim 1 , wherein the hydrophilic component is dissolved in an aqueous solvent to form an aqueous solution, and the hydrophobic component is dissolved in an organic solvent to form an organic solution.  
     
     
         7 . The method of  claim 1 , wherein the hydrophobic component comprises an active agent.  
     
     
         8 . The method of  claim 1 , wherein the hydrophilic component is dissolved in water and the hydrophobic component is dissolved in an organic solvent.  
     
     
         9 . The method of  claim 6 , wherein the hydrophilic component comprises an antibody.  
     
     
         10 . The method of  claim 6 , wherein the hydrophilic component comprises a protein.  
     
     
         11 . The method of  claim 1 , further comprising screening the dry particles.  
     
     
         12 . The method of  claim 1 , further comprising: 
 measuring a single dosage of the dry particles; and    packaging the single dosage.    
     
     
         13 . The method of  claim 1 , wherein the atomizing step is performed immediately after the combining step.  
     
     
         14 . The method of  claim 1 , wherein the atomizing step is performed using a rotary atomizer.  
     
     
         15 . The method of  claim 1 , wherein the atomizing step is performed using an internal mixing nozzle.  
     
     
         16 . The method of  claim 1 , wherein the atomizing step is performed using an external mixing nozzle.  
     
     
         17 . The method of  claim 1 , wherein the drying step is performed using a spray dryer.  
     
     
         18 . The method of  claim 1  or  2 , wherein the hydrophilic component comprises ammonium bicarbonate.  
     
     
         19 . A dry powder composition prepared by the method of  claim 1 .  
     
     
         20 . A dry powder composition prepared by the method of  claim 2 , wherein the active agent is human growth hormone.  
     
     
         21 . A method for preparing a dry powder composition, comprising: 
 combining a first component and a second component in a static mixer to form a combination, wherein one of the first component and the second component comprises an active agent, and wherein the active agent is incompatible with the other one of the first component and second component;    atomizing the combination flowing out of the static mixer to produce droplets; and    drying the droplets to form dry particles.    
     
     
         22 . The method of  claim 21 , wherein the first component comprises an active agent dissolved in an aqueous solvent.  
     
     
         23 . The method of  claim 22 , wherein the second component comprises an excipient dissolved in an organic solvent.  
     
     
         24 . A dry powder composition prepared by the method of  claim 21.