Methods for making polymer microspheres/nanospheres and encapsulating therapeutic proteins and other products
First Claim
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1. A method of making polymeric spheres having an average diameter of between 0.01 and 10.0 microns, comprising the steps of:
- a.) providing a polymer solution of a polymeric material dissolved in a first fluid, said first fluid consisting of a supercritical, critical or near-critical fluid; and
, b.) depressurizing said polymer solution as said polymer solution exits one or more orifices in the presence of a low solubility fluid, said low solubility fluid having low volatility and said polymeric material in a concentration which exceeds said solubility of said polymeric material in said low solubility fluid, said polymeric material forming spheres having an average diameter between 0.01 and 10.0 microns and said first fluid removed during depressurization.
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Abstract
This invention is for an improved process to formulate polymeric microspheres/nanospheres and encapsulate therapeutic proteins and other useful substances. Non-toxic supercritical or near-critical fluids with/without polar cosolvents are utilized to solubilize biodegradable polymers and form uniform polymer microspheres and nanospheres to encapsulate proteins with controlled-release characteristics.
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Citations
20 Claims
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1. A method of making polymeric spheres having an average diameter of between 0.01 and 10.0 microns, comprising the steps of:
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a.) providing a polymer solution of a polymeric material dissolved in a first fluid, said first fluid consisting of a supercritical, critical or near-critical fluid; and
,b.) depressurizing said polymer solution as said polymer solution exits one or more orifices in the presence of a low solubility fluid, said low solubility fluid having low volatility and said polymeric material in a concentration which exceeds said solubility of said polymeric material in said low solubility fluid, said polymeric material forming spheres having an average diameter between 0.01 and 10.0 microns and said first fluid removed during depressurization. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15, 17, 18, 19, 20)
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14. A method of making polymeric spheres having an average diameter of between 0.01 and 10.0 microns, comprising the steps of:
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a.) providing a polymer solution of a polymeric material in a first fluid, said first fluid consisting of a supercritical, critical or near-critical fluid;
b.) providing a second solution of a bioactive material in a second fluid;
c.) forming an admixture of said first solution and said second solution to form a third solution, said third solution comprising a supercritical, critical or near-critical fluid;
d.) depressurizing said third solution as said third solution exits one or more orifices in the presence of a low solubility fluid, said low solubility fluid having low volatility and said polymeric material in a concentration which exceeds said solubility of said polymeric material in said low solubility fluid, said polymeric material forming spheres having an average diameter of 0.01 to 10.0 microns, said spheres containing said bioactive material and said first fluid removed during depressurization.
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16. An apparatus for forming one or more polymeric spheres having an average diameter of between 0.01 and 10.0 microns, comprising:
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a.) an admixture vessel for receiving a polymer solution which polymer solution is a polymeric material dissolved in a first fluid, said first fluid consisting of a supercritical, critical or near-critical fluid;
b.) an orifice nozzle in communication with said admixture vessel for receiving said polymer solution; and
,c.) a depressurization vessel containing a low solubility fluid in communication with said orifice nozzle for receiving a stream of polymer solution as said polymer solution exits one or more orifices in the presence of said low solubility fluid, said low solubility fluid having low volatility and said polymeric material in a concentration which exceeds said solubility of said polymeric material in said low solubility fluid, said polymeric material forming spheres having an average diameter of 0.01 to 10.0 microns and said first fluid removed during depressurization.
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Specification