Method of producing submicron particles of a labile agent and use thereof
First Claim
1. A method for preparing a composition for the sustained release of a labile agent, comprising the steps of:
- a) forming a suspension comprising the labile agent dispersed in a polymer solution comprising at least one biocompatible polymer and at least one polymer solvent;
b) wet milling the suspension to achieve submicron particles of the labile agent; and
c) removing the polymer solvent thereby forming a solid polymer/labile agent matrix.
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Abstract
The present invention relates to a sustained release composition comprising micron particles of labile agent and a method of preparing and using the sustained release composition. The invention further relates to micron particles of a labile agent and a method of preparing the micron particles.
The method of the invention for preparing a composition for the sustained release of a labile agent, comprises forming a suspension comprising the labile agent dispersed in a polymer solution comprising at least one biocompatible polymer and at least one polymer solvent. The suspension is then wet milled to achieve micron particles of the labile agent. The polymer solvent is then removed resulting in a solid polymer/labile agent matrix. The composition for sustained release of a labile agent is likewise prepared according to the method of the invention.
The sustained release composition of the present invention can be used in a method for providing a therapeutically effective blood level of a labile agent, in a subject in need of treatment with said agent, for a sustained period comprising administering to the subject the sustained release composition described herein.
The method for preparing micron particles of a labile agent comprises forming a suspension comprising the labile agent, dispersed in a polymer solution comprising at least one biocompatible polymer and at least one polymer solvent, and wet milling of the suspension. The submicron particles of labile agent, as described herein, are prepared according to this method.
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Citations
41 Claims
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1. A method for preparing a composition for the sustained release of a labile agent, comprising the steps of:
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a) forming a suspension comprising the labile agent dispersed in a polymer solution comprising at least one biocompatible polymer and at least one polymer solvent;
b) wet milling the suspension to achieve submicron particles of the labile agent; and
c) removing the polymer solvent thereby forming a solid polymer/labile agent matrix. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A composition for the sustained release of a labile agent prepared by the method comprising the steps of:
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a) forming a suspension comprising the labile agent dispersed in a polymer solution comprising at least one biocompatible polymer and at least one polymer solvent;
b) wet milling the suspension to achieve submicron particles of the labile agent; and
c) removing the polymer solvent thereby forming a solid polymer/labile agent matrix. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40)
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41. The composition of claim 41 wherein the metal cation component is selected from the group consisting of Mg(OH)2, MgCO3, CaCO3, ZnCO3, Mg(OAc)2, Zn(OAc)2, ZnSO4, MgCl2, ZnCl2, MgSO4, zinc citrate and magnesium citrate.
Specification