Method for fabricating polymer-based controlled-release devices
First Claim
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1. A method for preparing a polymer/drug matrix mass, wherein the drug is a labile drug, consisting essentially of the steps of:
- (a) forming a polymer solution/drug mixture comprising a polymer dissolved in an organic solvent and a drug suspended in said solvent;
(b) removing the solvent from the polymer solution/drug mixture, thereby forming a solid polymer/drug matrix;
(c) fragmenting the solid polymer/drug matrix at a temperature below the glass transition temperature of the solid polymer/drug matrix, thereby forming polymer/drug matrix microparticles; and
(d) compressing the polymer/drug matrix microparticles to produce a polymer/drug matrix mass.
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Abstract
The present invention includes a method for producing an implantable polymer/drug matrix mass, comprising the steps of (1) forming a polymer solution/drug mixture comprising a polymer dissolved in an organic solvent and a suspended labile drug; (2) removing the solvent from the polymer solution/drug mixture, thereby forming a solid polymer/drug matrix; and (3) mechanically compressing the polymer/drug matrix, thereby forming an implantable polymer/drug matrix mass.
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Citations
11 Claims
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1. A method for preparing a polymer/drug matrix mass, wherein the drug is a labile drug, consisting essentially of the steps of:
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(a) forming a polymer solution/drug mixture comprising a polymer dissolved in an organic solvent and a drug suspended in said solvent;
(b) removing the solvent from the polymer solution/drug mixture, thereby forming a solid polymer/drug matrix;
(c) fragmenting the solid polymer/drug matrix at a temperature below the glass transition temperature of the solid polymer/drug matrix, thereby forming polymer/drug matrix microparticles; and
(d) compressing the polymer/drug matrix microparticles to produce a polymer/drug matrix mass. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
(i) freezing the polymer solution/drug mixture, thereby forming a solid polymer solution/drug mixture; and
(ii) extracting the solvent from the solid polymer solution/drug mixture.
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5. The method of claim 4 wherein the polymer solution/drug matrix is frozen by directing the polymer solution/drug mixture into a liquid nonsolvent, at a temperature below the freezing point of the polymer solution/drug mixture.
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6. The method of claim 5 wherein the polymer solution/drug mixture is directed into the liquid nonsolvent by pouring, atomizing, spraying, extruding or dripping the polymer solution/drug mixture into the liquid nonsolvent.
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7. The method of claim 4 wherein the polymer/drug matrix is frozen by directing the polymer solution/drug mixture onto a frozen nonsolvent bed in the presence of a liquified gas.
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8. The method of claim 4 wherein the solvent is extracted from the polymer solution/drug mixture by contacting the solid polymer solution/drug mixture with a nonsolvent, thereby extracting the solvent into the nonsolvent.
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9. The method of claim 4 wherein the solvent is extracted from the solid polymer solution/drug mixture by lyophilizing the solid polymer solution/drug mixture.
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10. The method of claim 1 wherein the solvent is removed from the polymer solution/drug mixture by a method comprising the steps of:
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(i) directing the polymer solution/drug mixture into a nonsolvent at a temperature suitable for precipitating the polymer/drug matrix, thereby forming a polymer/drug matrix-nonsolvent mixture; and
(ii) separating the nonsolvent and the polymer/drug matrix by filtering the polymer/drug matrix-nonsolvent mixture.
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11. The method of claim 1 wherein step (d) is performed at a temperature at or below ambient temperature.
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