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US 6,506,399 B2Granted
Biodegradable botulinum toxin implant
AssigneeAllergan Sales, Inc.
InventorStephen Donovan
Life of this patent
Estimating the term…
Abstract
A controlled release system for multiphasic, in vivo release of therapeutic amounts of botulinum toxin in a human patient over a prolonged period of time. The controlled release system can comprise a plurality of botulinum toxin incorporating polymeric microspheres.
Claims20
A pulsatile release botulinum toxin delivery system, comprising:
- (a) a carrier;
- (b) a botulinum toxin associated with the carrier, thereby forming a pulsatile release botulinum toxin delivery system,
- wherein therapeutic amounts of the botulinum toxin can be released from the carrier in a plurality of pulses in vivo upon subdermal implantation of the delivery system in a human patient without a significant immune system response and wherein the carrier is comprised of a biodegradable material selected from the group consisting of polymers of poly(lactides), poly(glycolides), collagens, poly(lactide-co-glycolides), poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polycaprolactone, polycarbonates, polyesteramides, polyanhydrides, poly(amino acids), polyorthoesters, polycyanoacrylates, poly(p-dioxanone), poly(alkylene oxalates), biodegradable polyurethanes, blends and copolymers thereof.
A controlled release system, comprising:
- (a) a biodegradable polymer;
- (b) between about 10 units and about 100,000 units of a botulinum toxin encapsulated by the polymer carrier, thereby forming a controlled release system, wherein therapeutic amounts of the botulinum toxin can be released from the carrier in a pulsatile manner in vivo upon subdermal implantation of the controlled release system in a human patient over a prolonged period of time extending from about 2 months to about 5 years without a significant immune system response and wherein the carrier is comprised of a biodegradable material selected from the group consisting of polymers of poly(lactides), poly(glycolides), collagens, poly(lactide-co-glycolides), poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polycaprolactone, polycarbonates, polyesteramides, polyanhydrides, poly(amino acids), polyorthoesters, polycyanoacrylates, poly(p-dioxanone), poly(alkylene oxalates), biodegradable polyurethanes, blends and copolymers thereof.
A method for making a controlled release system, the method comprising the steps of:
- (a) dissolving a polymer in a solvent to form a polymer solution;
- (b) mixing or dispersing a botulinum toxin in the polymer solution to form a polymer-botulinum toxin mixture, and;
- (c) allowing the polymer-botulinum toxin mixture to set or cure, thereby making a controlled release system for pulsatile release of the botulinum toxin without a significant immune system response, wherein the polymer is comprised of a biodegradable material selected from the group consisting of polymers of poly(lactides), poly(glycolides), collagens, poly(lactide-co-glycolides), poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polycaprolactone, polycarbonates, polyesteramides, polyanhydrides, poly(amino acids), polyorthoesters, polycyanoacrylates, poly(p-dioxanone), poly(alkylene oxalates), biodegradable polyurethanes, blends and copolymers thereof.
A pulsatile release botulinum toxin delivery system, comprising:
- (a) a carrier comprised of a biodegradable material selected from the group consisting of polymers of poly(lactides), poly(glycolides), collagens, poly(lactide-co-glycolides), poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polycaprolactone, polycarbonates, polyesteramides, polyanhydrides, poly(amino acids), polyorthoesters, polycyanoacrylates, poly(p-dioxanone), poly(alkylene oxalates), biodegradable polyurethanes, blends and copolymers thereof;
- (b) a stabilized botulinum toxin associated with the carrier, thereby forming a pulsatile release botulinum toxin delivery system,
- wherein therapeutic amounts of the botulinum toxin can be released from the carrier in a plurality of pulses in vivo upon subdermal implantation of the delivery system in a human patient without a significant immune system response.
Dependencies are inferred from the claim text.