Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Patent
1996-05-14
1998-10-06
Kulkosky, Peter F.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
514951, 424426, A61K 914
Patent
active
058173439
ABSTRACT:
A method for forming polymer/drug microparticles 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) fragmenting the polymer/drug matrix at a temperature below the glass transition temperature of the polymer/drug matrix, thereby forming polymer/drug matrix microparticles.
In one embodiment, the solvent is removed from a polymer solution/drug mixture by freezing the polymer solution/drug mixture and extracting the solvent from the resulting solid polymer solution/drug matrix. The polymer can be a biocompatible polymer, such as poly(lactic acid-co-glycolic acid). The drug can be a labile drug, such as a protein, or a polynucleotide. Another embodiment of the present invention includes the polymer/drug matrix microparticles which are formed by the method outlined above. A further embodiment of 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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Alkermes, Inc.
Kulkosky Peter F.
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