Method of preparing biological materials and preparations produced using same

Abstract

Methods for preparing products containing moisture-sensitive materials, including biological materials such as proteins, peptides or live cells, comprising at least the steps: (i) providing a coating liquid comprising at least one active, a sugar polymer and a water soluble/miscible solvent; (ii) providing a quantity of microparticles comprising at least water soluble gel forming solid particles; (iii) fluidizing said quantity of microparticles within a processing chamber of a of a suitable apparatus to form a fluidized bed of said microparticles; (iv) spraying said coating liquid onto said fluidized bed from beneath the fluidized bed to coat said microparticles therewith under saturated moisture conditions; and (vi) allowing coated microparticles to dry, are described. Also described are compositions and uses.

1 - 32 . (Cancelled).  
     
     
         33 . A method for stabilizing a biologically active material comprising the steps of: 
 (a) fluidizing microparticles within a processing chamber to form a fluidized bed of said microparticles, wherein said microparticles comprise water-soluble gel forming solid particles;    (b) under saturated moisture conditions, spraying a coating liquid onto said fluidized bed of step (a) from beneath said fluidized bed to coat said microparticles with said coating liquid, wherein said coating liquid comprises: 
 (i) at least one biologically active material,  
 (ii) a sugar polymer, and  
 (iii) a water soluble/miscible solvent; and  
   (c) drying the resulting coated microparticles of step (b).    
     
     
         34 . The method of  claim 33 , further comprising coating the resulting microparticles of step (c) with a coating selected from the group consisting of an enteric coating, a film coating, a moisture repellant coating, a taste-masking coating and a combination of any such coatings.  
     
     
         35 . The method of  claim 33 , wherein the drying in step (c) is heat drying.  
     
     
         36 . The method of claims  33 , wherein the biologically active material is selected from the group consisting of a protein, a peptide, and a cell.  
     
     
         37 . The method of  claim 33 , wherein the water soluble/miscible solvent is selected from the group consisting of glycerol, propylene glycol, and a combination of glycerol and propylene.  
     
     
         38 . The method of  claim 33 , wherein the sugar polymer is selected from the group comprising dextran, fructose, fruitose, glucose, invert sugar, lactitol, lactose, maltitol, maltodextrin, maltose, mannitol, sorbitol, sucrose, trehalose, isomalt, xylitol, polydextrose, and a combination thereof.  
     
     
         39 . The method of  claim 33 , wherein the water soluble gel forming solid particles comprise a member selected from the group consisting of an acrylate, acrylate derivative, albumin, alginate, carbomer, carrageenan, cellulose, cellulose derivative, dextran, dextrin, gelatine, polyvinylpyrrolidone, and starch.  
     
     
         40 . The method of  claim 33 , wherein said method is conducted in a moisture saturated environment.  
     
     
         41 . The method of  claim 33 , wherein said method is conducted in an oxygen free environment.  
     
     
         42 . The method of  claim 33 , wherein the coated microparticles are formed into a composition for injection, a sublingual tablet, an oral tablet, a sustained release sublingual tablet, microcapsules, pessaries, preconstituted solid dose for nasal spray or drops, aqueous drops, eye wash or drops, skin washing solutions, or a feed premix.  
     
     
         43 . The method of  claim 33 , wherein said microparticles have a particle size of 50 microns to one millimeter.  
     
     
         44 . The method of  claim 33 , wherein the biologically active material is selected from the group consisting of a hormone, cytokine, growth factor and a combination of any two or more thereof.  
     
     
         45 . The method of  claim 33 , wherein the biologically active material is selected from the group consisting of a human or animal growth hormone, erythropoietin, calcitonin, interferon, interleukin, insulin and colony stimulating factor.  
     
     
         46 . The method of  claim 33 , wherein the biologically active material is an enzyme.  
     
     
         47 . The method of  claim 46 , wherein said enzyme is selected from the group consisting of streptokinase, muramidase, pancreas, amylase, protease, lypase, cellulase, bromelain and papain.  
     
     
         48 . The method of  claim 33 , wherein the biologically active material is glucan.  
     
     
         49 . The method of  claim 48 , wherein said glucan is β-1,3-glucan.  
     
     
         50 . The method of  claim 33 , wherein the biologically active material is a microorganism.  
     
     
         51 . The method of  claim 50 , wherein said microorganism is  Bifidus  or  Lactobacilli.    
     
     
         52 . A product produced by the method of any of  claims 33  to  51 .