Method of preparing biological materials and preparations produced using same
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 .