Oil-in-oil emulsified polymeric implants containing a hypotensive lipid and prostamide
First Claim
1. A method for producing therapeutic polymeric microparticles, comprising encapsulating a prostamide component with a polymeric component to form a population of prostamide-encapsulated microparticles by an oil-in-oil emulsion process, wherein the polymeric component comprises a poly(lactide-co-glycolide) (PLGA) copolymer, the oil-in-oil emulsion process comprising:
- forming a first composition comprising a prostamide component, a poly(lactide-co-glycolide) (PLGA) copolymer, and an organic solvent;
forming a second oil-containing composition;
mixing the first composition and the second oil-containing composition to form an oil-in-oil emulsion;
drying the emulsion to form a dried emulsion product;
contacting the dried emulsion product with a solvent to form a solvent-containing composition;
removing the solvent from the solvent-containing composition to form a population of microparticles having a maximum particle diameter less than about 200 μ
m and comprising the prostamide component and the polymeric component; and
terminally sterilizing the polymeric microparticles, wherein at least 80% of the prostamide component remains stable after sterilization; and
wherein the prostamide component comprises a compound having the formula (I)
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Accused Products
Abstract
Biocompatible intraocular implants, such as microparticles, include a prostamide component and a biodegradable polymer that is effective in facilitating release of the prostamide component into an eye for an extended period of time. The prostamide component may be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. Or, the prostamide component may be encapsulated by the polymeric component. The present implants include oil-in-oil emulsified implants or microparticles. Methods of producing the present implants are also described. The implants may be placed in an eye to treat or reduce at least one symptom of an ocular condition, such as glaucoma.
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Citations
11 Claims
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1. A method for producing therapeutic polymeric microparticles, comprising encapsulating a prostamide component with a polymeric component to form a population of prostamide-encapsulated microparticles by an oil-in-oil emulsion process, wherein the polymeric component comprises a poly(lactide-co-glycolide) (PLGA) copolymer, the oil-in-oil emulsion process comprising:
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forming a first composition comprising a prostamide component, a poly(lactide-co-glycolide) (PLGA) copolymer, and an organic solvent; forming a second oil-containing composition; mixing the first composition and the second oil-containing composition to form an oil-in-oil emulsion; drying the emulsion to form a dried emulsion product; contacting the dried emulsion product with a solvent to form a solvent-containing composition; removing the solvent from the solvent-containing composition to form a population of microparticles having a maximum particle diameter less than about 200 μ
m and comprising the prostamide component and the polymeric component; andterminally sterilizing the polymeric microparticles, wherein at least 80% of the prostamide component remains stable after sterilization; and wherein the prostamide component comprises a compound having the formula (I) - View Dependent Claims (2, 3, 4, 5, 6, 8, 9, 10)
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7. A method for producing therapeutic polymeric microparticles, comprising encapsulating bimatoprost with a polymeric component to form a population of bimatoprost-encapsulated microparticles by an oil-in-oil emulsion process, wherein the polymeric component comprises a poly(lactide-co-glycolide) (PLGA) copolymer,
the oil-in-oil emulsion process comprising: -
forming a first composition comprising bimatoprost, a poly(lactide-co-glycolide) (PLGA) copolymer, and an organic solvent; forming a second oil-containing composition; mixing the first composition and the second oil-containing composition to form an oil-in-oil emulsion; evaporating the oil-in-oil emulsion to form an evaporated product; contacting the evaporated product with a solvent to form a solvent-containing composition; and removing the solvent from the solvent-containing composition to form a population of microparticles having a maximum particle diameter less than about 200 μ
m and comprising bimatoprost and the polymeric component. - View Dependent Claims (11)
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Specification