Low temperature processes for making cyclic lipid implants for intraocular use
First Claim
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1. A low temperature process for making an intraocular implant, the process comprising the steps of:
- (a) combining a cyclic lipid therapeutic agent and a polymer to form a mixture;
(b) heating the mixture to a temperature between about 50°
C. and about 80°
C., and;
(c) extruding the heated mixture, thereby making an implant suitable for intraocular use.
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Abstract
Biocompatible implants comprising a cyclic lipid therapeutic agent are made using a low temperature melt extrusion process. The implants are suitable for intraocular use to treat an ocular condition.
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Citations
24 Claims
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1. A low temperature process for making an intraocular implant, the process comprising the steps of:
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(a) combining a cyclic lipid therapeutic agent and a polymer to form a mixture; (b) heating the mixture to a temperature between about 50°
C. and about 80°
C., and;(c) extruding the heated mixture, thereby making an implant suitable for intraocular use. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 11, 23, 24)
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10. A low temperature process for making an intraocular implant, the process comprising the steps of:
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(a) combining a prostaglandin analog and a biodegradable polymer to form a mixture; (b) heating the mixture to a temperature between about 50°
C. and about 80°
C., and;(c) extruding the heated mixture, thereby making an implant suitable for intraocular use.
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12. A process for making an intraocular implant, the process comprising the steps of:
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(a) combining; (i) a cyclic lipid therapeutic agent; (ii) a first biodegradable polymer, and; (ii) a second biodegradable polymer to form a mixture, wherein; (α
) the first biodegradable polymer and the second biodegradable polymer are different polymers;(β
) the solubilities of the cyclic lipid therapeutic agent, the first biodegradable polymer, and the second biodegradable polymer are substantially similar, and;(γ
) the melt temperature of the second biodegradable polymer is lower than the melt transition temperature of the first biodegradable polymer,(b) heating the mixture to the lower melt temperature of the second biodegradable polymer, so that the second biodegradable polymer can function as a solvent for the cyclic lipid therapeutic agent and for the first biodegradable polymer, wherein the melt temperature of the second biodegradable polymer is lower than the temperature at which the cyclic lipid therapeutic agent exhibits a substantial loss of potency, and; (c) extruding the heated mixture, thereby making an implant suitable for intraocular use. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A process for making an intraocular implant, the process comprising the steps of:
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(a) combining; (i) a prostaglandin analog, wherein the prostaglandin analog comprises from about 5% to about 30% by weight of the implant; (ii) a poly(lactide-co-glycolide) copolymer, wherein the poly(lactide-co-glycolide) comprises from about 30% to about 90% by weight of the implant. and; (ii) a second biodegradable polymer to form a mixture, wherein the second biodegradable polymer comprises from about 5% to about 40% by weight of the implant, and wherein; (α
) the a poly(lactide-co-glycolide) copolymer and the second biodegradable polymer are different polymers;(β
) the solubilities of the prostaglandin analog, the poly(lactide-co-glycolide) copolymer, and the second biodegradable polymer are all within about 10 Mpa1/2 of each other, and;(γ
) the melt temperature of the second biodegradable polymer is lower than the melting point of the a poly(lactide-co-glycolide) copolymer,(b) heating the mixture to the lower melt temperature of the second biodegradable polymer, so that the second biodegradable polymer can function as a solvent for the prostaglandin analog and for the a poly(lactide-co-glycolide) copolymer, and;
(c) extruding the heated mixture, thereby making an implant suitable for intraocular use, wherein the prostaglandin analog released from the implant has a potency of at least about 50%.
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Specification