Controlled release ACTH containing microspheres
First Claim
1. A polymeric microsphere having a diameter of less than 1000 microns, formed of a biocompatible polymer selected from the group consisting of poly(lactide), poly(lactide-co-glycolide), poly(caprolactone), polycarbonates, polyamides, polyanhydrides, polyamino acids, polyortho esters, polyacetals, polycyanoacrylates, degradable polyurethanes, polyacrylates, polymers of ethylene-vinyl acetate and other acyl substituted cellulose acetates, polysaccharides, non-erodible polyurethanes, polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulphonated polyolefins, polyethylene oxide, copolymers and mixtures thereof and an excipient modulating polymer erosion rate selected from the group consisting of inorganic acids, organic acids, inorganic bases, organic bases, and surfactants in an amount between 0.1 and thirty percent (w/w, polymer), containing adrenocorticotropic hormone (ACTH) in a concentration of between 0.1% and 50% by weight, wherein the microspheres release the ACTH under physiological conditions over a period of time greater than one day by diffusion and degradation of the polymeric matrix.
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Abstract
ACTH polymeric controlled release systems are described wherein the ACTH retains good biological activity and is released over an extended period of time following administration by injection. In the preferred embodiment, the ACTH polymeric microspheres are made using very cold temperatures to freeze the polymer-ACTH mixtures into polymeric microspheres with very high retention of biological activity and material. Sustained release of biologically active ACTH is achieved when the microspheres are tested in vitro, extending over a period of greater than one day to several months. Altered release can be achieved by inclusion of degradation modifiers, pore forming agents, and stabilizers of the ACTH.
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Citations
12 Claims
- 1. A polymeric microsphere having a diameter of less than 1000 microns, formed of a biocompatible polymer selected from the group consisting of poly(lactide), poly(lactide-co-glycolide), poly(caprolactone), polycarbonates, polyamides, polyanhydrides, polyamino acids, polyortho esters, polyacetals, polycyanoacrylates, degradable polyurethanes, polyacrylates, polymers of ethylene-vinyl acetate and other acyl substituted cellulose acetates, polysaccharides, non-erodible polyurethanes, polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulphonated polyolefins, polyethylene oxide, copolymers and mixtures thereof and an excipient modulating polymer erosion rate selected from the group consisting of inorganic acids, organic acids, inorganic bases, organic bases, and surfactants in an amount between 0.1 and thirty percent (w/w, polymer), containing adrenocorticotropic hormone (ACTH) in a concentration of between 0.1% and 50% by weight, wherein the microspheres release the ACTH under physiological conditions over a period of time greater than one day by diffusion and degradation of the polymeric matrix.
- 8. A method for administering ACTH comprising administering a biocompatible polymeric microsphere containing between 0.1 and 50% ACTH and an excipient modulating polymer erosion rate, and having a diameter of less than one hundred eighty microns into a patient in need of treatment with ACTH, wherein the polymeric microsphere is formed of a biocompatible polymer selected from the group consisting of poly(lactide), poly(lactide-co-glycolide), poly(caprolactone), polycarbonates, polyamides, polyanhydrides, polyamino acids, polyortho esters, polyacetals, polycyanoacrylates, degradable polyurethanes, polyacrylates, polymers of ethylene-vinyl acetate and other acyl substituted cellulose acetates, polysaccharides, non-erodible polyurethanes, polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulphonated polyolefins, polyethylene oxide, copolymers, and mixtures thereof and an excipient modulating polymer erosion rate selected from the group consisting of inorganic acids, organic acids, inorganic bases, organic bases, and surfactants in an amount between 0.1 and thirty percent (w/w, polymer), wherein the ACTH is released over a period of time in excess of one day by diffusion and degradation of the polymeric matrix.
Specification