CONTROLLED RELEASE MICROENCAPSULATED NGF FORMULATION
First Claim
1. A method of making a microsphere device for controlled sustained release of NGF having a decreased NGF aggregation characteristic, comprising mixing NGF in solution with an NGF-stabilizing metal salt of a metal that binds NGF, wherein the molar ratio of NGF to metal is 1 to 4 to 1 to 50, and microencapsulating the NGF-metal mixture to form a microsphere containing NGF and metal capable of controlled sustained release of NGF.
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Accused Products
Abstract
NGF microencapsulation compositions having controlled release characteristics, preferably with increased stability, for the NGF component, particularly human recombinant NGF (“rhNGF”) are provided that yield enhanced stability of NGF for use in promoting nerve cell growth, repair, survival, differentiation, maturation or function. Methods for making and using such compositions are also provided.
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Citations
32 Claims
- 1. A method of making a microsphere device for controlled sustained release of NGF having a decreased NGF aggregation characteristic, comprising mixing NGF in solution with an NGF-stabilizing metal salt of a metal that binds NGF, wherein the molar ratio of NGF to metal is 1 to 4 to 1 to 50, and microencapsulating the NGF-metal mixture to form a microsphere containing NGF and metal capable of controlled sustained release of NGF.
- 28. A method for administering NGF, comprising administering to a patient in need of treatment a biocompatible polymeric microsphere, having a diameter of less than 300 microns, containing 0.1 to 50% NGF by weight and a metal complexed to NGF, wherein a therapeutically effective amount of NGF is released from the microspheres over a period of time in excess of one day.
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31. A polymeric microsphere device having a diameter of less than 1000 microns for sustained controlled release of NGF, comprising a biocompatible polymeric microsphere containing 0.1 to 50% NGF by weight complexed with an NGF-stabilizing metal that binds NGF, which device is capable of releasing NGF over a period of time in excess of one day.
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32. A method of increasing the stability of NGF in a microencapsulated composition containing NGF as active principle, comprising incorporating an NGF-stabilizing and binding metal into an NGF aqueous solution prior to drying the solution for microencapsulation.
Specification