High pressure spray-dry of bioactive materials

Abstract

This invention provides compositions and methods providing, e.g., stable powder particles containing bioactive materials. The methods include, e.g., high pressure spraying of the bioactive materials in solution or suspension, with viscosity enhancing agents and/or surfactants. Compositions of the invention provide, e.g., high initial purity, high stability in storage, and reconstitution at high concentrations.

1 - 100 . (canceled) 
     
     
         101 . A composition of dry powder particles comprising:
 an average particle size ranging from about 2 μm to about 200 μm;   a particle density of about 1; and,   antibodies comprising more than about 90 percent purity, and about 40 weight percent to about 60 weight percent of the particles.   
     
     
         102 . The composition of  claim 101 , wherein the average particle size is 10 μm, or more. 
     
     
         103 . The composition of  claim 101 , wherein the antibodies comprise about 97 percent purity, or more. 
     
     
         104 . The composition of  claim 101 , wherein the antibodies comprise less than about 3% aggregates on reconstitution of the powder particles after storage at about 4° C. for up to about 7 years. 
     
     
         105 . The composition of  claim 101 , wherein the antibodies comprise less than about 3% aggregates on reconstitution of the powder particles after storage at about 25° C. for about up to about 2 years. 
     
     
         106 . The composition of  claim 101 , further comprising sucrose or trehalose comprising about 40 weight percent to about 60 weight percent of the particles. 
     
     
         107 . The composition of  claim 101 , further comprising arginine. 
     
     
         108 . A composition of particles comprising a virus wherein the composition is prepared by a process comprising:
 preparing an aqueous suspension or solution comprising the virus and a polyol selected from the group consisting of sucrose, threhalose, and mannitol;   spraying the suspension or solution through a nozzle at high pressure, thereby forming a mist of fine droplets;   drying the droplets to form powder particles; and,   recovering the particles.   
     
     
         109 . The composition of  claim 108 , wherein the virus comprises influenza virus. 
     
     
         110 . The composition of  claim 108 , wherein a viability of the virus is not reduced significantly in the recovered particles. 
     
     
         111 . The composition of  claim 108 , wherein the polyol comprises a concentration providing a 5% or more increase in viscosity, or a 0.05 centipoise or more increase in viscosity, over the suspension or solution without the polyol. 
     
     
         112 . The composition of  claim 108 , wherein said spraying further comprises atomization with a high pressure gas comprising a pressure more than 10% below a critical pressure for the gas, or more than 10% above a critical temperature for the gas. 
     
     
         113 . The composition of  claim 108 , further comprising about 0.2% of a surface active agent.