Formulations for controlled, prolonged release of GM-CSF have been developed. These are based on solid microparticles formed of the combination of biodegradable, synthetic polymers such as poly(lactic acid) (PLA), poly(glycolic acid) (PGA), and copolymers thereof with excipients and drug loadings th
Formulations for controlled, prolonged release of GM-CSF have been developed. These are based on solid microparticles formed of the combination of biodegradable, synthetic polymers such as poly(lactic acid) (PLA), poly(glycolic acid) (PGA), and copolymers thereof with excipients and drug loadings that yield zero order or first order release, or multiphasic release over a period of approximately three to twenty one days, preferably one week, when administered by injection. In the preferred embodiment, the microparticles are microspheres having diameters in the range of 10 to 60 microns, formed of a blend of PLGA having different molecular weights, most preferably 6,000, 30,000 and 41,000. Other embodiments have been developed to alter the release kinetics or the manner in which the drug is distributed in vivo. For example, in some cases a polymer is selected which elicits a mild inflammatory reaction, for example, PLGA and polyanhydrides can act as chemoattractant, either due to the polymer itself or minor contaminants in the polymer, or polymers which are bioadhesive are used for transmucosal or oral delivery. In another embodiment, the GM-CSF is administered in a hydrogel which can be injected subcutaneous or at a specific site for controlled release. The microparticles or hydrogel are administered to the patient in an amount effect to stimulate proliferation of hematopoietic cells, especially white cells.
대표청구항▼
[ We claim:] [1.] A method for delivering GM-CSF to a patient in need thereof comprising administering to the patient an effective amount of GM-CSF dispersed within biodegradable polymeric microparticles providing a sustained, controlled release under physiological conditions over a period of one da
[ We claim:] [1.] A method for delivering GM-CSF to a patient in need thereof comprising administering to the patient an effective amount of GM-CSF dispersed within biodegradable polymeric microparticles providing a sustained, controlled release under physiological conditions over a period of one day to at least one week, wherein the microparticles are formed from a biodegradable, synthetic polymer selected from the group consisting of polyhydroxy acids, polyanhydrides, polyorthoesters, polyphosphazenes, copolymers thereof, and blends thereof, using a method retaining greater than 60% of the biological activity of the GM-CSF after release from the polymer.
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이 특허에 인용된 특허 (16)
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