Controlled release microencapsulated NGF formulation
AssigneeGenentech, Inc.
InventorsJeffrey L. Cleland, Xanthe M. Lam, Eileen T. Duenas
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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.
Claims31
A method of making a biodegradable polymeric microsphere device for controlled sustained release of NGF, comprising mixing NGF in solution with an NGF-stabilizing metal salt, a biodegradable polymer, and microencapsulating the NGF-metal mixture to form a metal salt stabilized microsphere with a particle size from about 0.1 to about 300 μm, wherein said microsphere contains NGF and metal capable of controlled sustained release of NGF for a period of time greater than one day, and wherein said NGF promotes basal forebrain cholinergic neuron outgrowth.
A method of increasing the stability of NGF in a biodegradable microencapsulated composition, comprising incorporating an NGF-stabilizing metal salt into an NGF aqueous biodegradable polymer-containing solution prior to drying the solution for microencapsulation, whereby microspheres capable of releasing NGF over a period of time in excess of one day are produced, and wherein said NGF promotes basal forebrain cholinergic neuron outgrowth.
Dependencies are inferred from the claim text.