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US 2010/0166874 A1Published application
Technology for Preparation of Macromolecular Microspheres
OwnerMichael P. Malakhov, Fang Fanginventors
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Abstract
Microspheres are produced by contacting an aqueous solution of a protein or other macromolecule with an organic solvent and a counterion, and chilling the solution. The microspheres are useful for preparing pharmaceuticals of defined dimensions.
Claims75
(canceled)
A method of making protein-based microparticles, comprising:
- a) mixing together:
- (i) a solution containing a protein in an aqueous solvent, (ii) a counterion and (iii) one or more organic solvents, wherein each organic solvent in the resulting mixture is volatile and none are a polymer;
- and
- b) providing the resulting mixture at or cooling the resulting mixture to a temperature below about 25° C., whereby microparticles comprising the protein are formed.
1 more element
A method of making protein-based microparticles, comprising:
- a) providing a solution comprising a protein, a counterion, an aqueous solvent and one or more organic solvents, wherein each organic solvent present in the solution is a volatile solvent other than ethanol and none are a polymer;
- and
- b) providing the solution at or cooling the solution to a temperature below about 25° C., whereby microparticles comprising the protein are formed.
A method of making protein-based microparticles, comprising:
- a) providing a solution comprising a protein, a counterion, an aqueous solvent and an organic solvent;
- b) providing the solution at or cooling the solution to a temperature below about 25° C., whereby a composition containing microparticles comprising the protein is formed;
- and
- c) without any other separation and/or washing steps, isolating the microparticles from unincorporated aqueous solvent and organic solvent by lyophilization.
1 more element
A method of making a protein-based composition, comprising:
- a) providing a solution comprising a protein, a counterion, an aqueous solvent and an organic solvent;
- b) providing the solution at or cooling the solution to a temperature below about 25° C., whereby a composition containing microparticles comprising the protein is formed;
- and
- c) without any other separation and/or washing steps, isolating the microparticles from the unincorporated reagents by lyophilization.
1 more element
A method of making protein-based microparticles, comprising:
- a) providing a solution comprising a protein, a counterion, an aqueous solvent and an organic solvent, wherein the organic solvent is selected from among methanol, ethanol, 1-propanol, isopropanol, tert-butyl alcohol, butanol, acetone, acetonitrile, acetic acid, ethyl acetate, methyl ethyl ketone, methyl t-butyl ether, and dimethyl sulfoxide, and the counterion is selected from among citrate, phosphate, sulfate, pivalate, rubidium, bromine, perchlorate, triethylamine, glycine, itaconate, and arginine, and any salt, acid, or base form thereof;
- and
- b) providing the solution at or cooling the solution to a temperature below about 25° C., whereby microparticles comprising the protein are formed.
A method of making protein-based microparticles, comprising:
- a) providing a solution comprising a protein, a counterion, an aqueous solvent and one or more organic solvents, wherein the total amount of organic solvent(s) in the resulting solution is 50% or less v/v and each organic solvent present in the solution is volatile and none are a polymer;
- and
- b) providing the solution at or cooling the solution to a temperature below about 25° C., whereby microparticles comprising the protein are formed.
A composition comprising microparticles of a protein and a counterion, wherein:
- (a) the size of the microparticles is from about 0.5 μm to about 10 μm;
- and
- (b) the counterion is selected from among citrate, phosphate, sulfate, pivalate, rubidium, bromine, perchlorate, triethylamine, glycine, itaconate, and arginine, and any salt, acid, or base form thereof.
Dependencies are inferred from the claim text.