Intraocular drug delivery systems containing excipients with reduced toxicity and related methods
First Claim
1. A therapeutic drug delivery system useful for placement into a posterior segment of an eye of an individual, comprising:
- a therapeutic component;
a cyclodextrin component complexed with the therapeutic component to enhance a therapeutic efficacy of the therapeutic component in treating an ocular condition; and
a polymeric component associated with the therapeutic component and cyclodextrin component in the form of a drug delivery element structured to be placed in the posterior segment of an eye of an individual.
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Accused Products
Abstract
Drug delivery systems suitable for administration into the interior of an eye of a person or animal are described. The present systems include one or more components which are effective in improving a release profile of a drug from the system, improving the stability of the drug, and improving the ocular tolerability of the drug. The present systems include one or more therapeutic agents in amounts effective in providing a desired therapeutic effect when placed in an eye, and an excipient component with reduced toxicity to retinal cells. The excipient component may include a cyclodextrin component that may be complexed with the therapeutic agents to provide advantages over existing intraocular drug delivery systems. The cyclodextrin component of the present systems have a reduced toxicity relative to benzyl alcohol or polysorbate 80. The drug delivery systems include one or more drug delivery elements such as microparticles, bioerodible implants, non-bioerodible implants, and combinations thereof. Methods of using and producing the drug delivery systems are also described.
172 Citations
24 Claims
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1. A therapeutic drug delivery system useful for placement into a posterior segment of an eye of an individual, comprising:
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a therapeutic component;
a cyclodextrin component complexed with the therapeutic component to enhance a therapeutic efficacy of the therapeutic component in treating an ocular condition; and
a polymeric component associated with the therapeutic component and cyclodextrin component in the form of a drug delivery element structured to be placed in the posterior segment of an eye of an individual. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 17, 24)
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13. A therapeutic drug delivery system useful for placement into a posterior segment of an eye of an individual, comprising:
at least one drug delivery element selected from the group consisting of (i) poly (lactide-co-glycolide) polymeric microspheres comprising a cyclodextrin encapsulated drug;
(ii) monolithic poly (lactide-co-glycolide) polymeric implants comprising a cyclodextrin encapsulated drug;
(iii) biodegradable polymeric implants comprising a cyclodextrin encapsulated drug; and
(iv) non-biodegradable polymeric implants comprising a cyclodextrin encapsulated drug, the cyclodextrin being effective in enhancing a therapeutic efficacy of the drug when the drug delivery element is placed in the posterior segment of the eye by augmenting a release profile of the drug from the drug delivery element relative to a second substantially identical drug delivery element that includes the same drug and no cyclodextrin.- View Dependent Claims (14, 18)
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15. A therapeutic drug delivery system useful for placement into a posterior segment of an eye of an individual, comprising:
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a polymeric component effective in forming an implant useful for placement into the posterior segment of an eye of an individual;
a therapeutic component present in an amount effective in providing a desired therapeutic effect to an individual when the implant is placed in the posterior segment of the eye; and
a cyclodextrin component in an amount from about 0.5% (w/w) to about 25.0% (w/w) of the implant and effective in solubilizing a therapeutic agent of the therapeutic component. - View Dependent Claims (16, 19)
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20. A therapeutic drug delivery system useful for placement into a posterior segment of an eye of an individual, comprising:
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a therapeutic component;
an excipient component present in an amount that is less toxic to retinal pigment epithelial cells relative to an equal amount of an agent selected from the group consisting of polysorbate 80 and benzyl alcohol; and
a polymeric component associated with the therapeutic component and excipient component in the form of a drug delivery element structured to be placed in the posterior segment an eye of an individual. - View Dependent Claims (21, 22, 23)
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Specification