Systems for sustained intraocular delivery of low solubility compounds from a port delivery system implant
First Claim
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1. A formulation for controlled release of a therapeutic agent in vitreous of an eye from a therapeutic delivery device having a reservoir chamber coupled to a porous structure, the formulation comprising a solution which comprises:
- (i) from about 20 mg/mL to about 100 mg/mL of a low water soluble therapeutic agent, (ii) a cyclodextrin, and (iii) a polysorbate, a block copolymer of ethylene oxide and propylene oxide, a di-block copolymer of polyethylene oxide and polypropylene oxide, a tri-block copolymer of polyethylene oxide and polypropylene oxide, an ethoxylated emulsifier, a polyethylene glycol ester, sucrose laurate, tocopherol-polyethyleneglycol-succinate, a phospholipid, or a combination of two or more thereof;
wherein a ratio of the cyclodextrin to the therapeutic agent is from 1;
1 to 15;
1; and
wherein the therapeutic agent remains in solution in the reservoir chamber upon contact with the vitreous fluid of the eye.
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Abstract
Therapeutic agent delivery formulations for the sustained release of therapeutic agents from a Port Delivery System (PDS) implant is described in this application.
447 Citations
22 Claims
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1. A formulation for controlled release of a therapeutic agent in vitreous of an eye from a therapeutic delivery device having a reservoir chamber coupled to a porous structure, the formulation comprising a solution which comprises:
- (i) from about 20 mg/mL to about 100 mg/mL of a low water soluble therapeutic agent, (ii) a cyclodextrin, and (iii) a polysorbate, a block copolymer of ethylene oxide and propylene oxide, a di-block copolymer of polyethylene oxide and polypropylene oxide, a tri-block copolymer of polyethylene oxide and polypropylene oxide, an ethoxylated emulsifier, a polyethylene glycol ester, sucrose laurate, tocopherol-polyethyleneglycol-succinate, a phospholipid, or a combination of two or more thereof;
wherein a ratio of the cyclodextrin to the therapeutic agent is from 1;
1 to 15;
1; and
wherein the therapeutic agent remains in solution in the reservoir chamber upon contact with the vitreous fluid of the eye.
- (i) from about 20 mg/mL to about 100 mg/mL of a low water soluble therapeutic agent, (ii) a cyclodextrin, and (iii) a polysorbate, a block copolymer of ethylene oxide and propylene oxide, a di-block copolymer of polyethylene oxide and polypropylene oxide, a tri-block copolymer of polyethylene oxide and polypropylene oxide, an ethoxylated emulsifier, a polyethylene glycol ester, sucrose laurate, tocopherol-polyethyleneglycol-succinate, a phospholipid, or a combination of two or more thereof;
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2. A formulation for controlled release of a therapeutic agent in vitreous of an eye from a therapeutic delivery device having a reservoir chamber coupled to a porous structure, the formulation comprising:
- (i) from about 20 mg/mL to about 100 mg/mL of a low water soluble therapeutic agent, (ii) and a cyclodextrin, and (iii) a polysorbate, a block copolymer of ethylene oxide and propylene oxide, a di-block copolymer of polyethylene oxide and polypropylene oxide, a tri-block copolymer of polyethylene oxide and polypropylene oxide, an ethoxylated emulsifier, a polyethylene glycol ester, sucrose laurate, tocopherol-polyethyleneglycol-succinate, a phospholipid, or a combination of two or more thereof;
wherein a ratio of the cyclodextrin to the therapeutic agent is from 1;
1 to 15;
1. - View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
- (i) from about 20 mg/mL to about 100 mg/mL of a low water soluble therapeutic agent, (ii) and a cyclodextrin, and (iii) a polysorbate, a block copolymer of ethylene oxide and propylene oxide, a di-block copolymer of polyethylene oxide and polypropylene oxide, a tri-block copolymer of polyethylene oxide and polypropylene oxide, an ethoxylated emulsifier, a polyethylene glycol ester, sucrose laurate, tocopherol-polyethyleneglycol-succinate, a phospholipid, or a combination of two or more thereof;
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22. A formulation for controlled release of a therapeutic agent in vitreous of an eye from a therapeutic delivery device having a reservoir chamber coupled to a porous structure, the formulation comprising:
- (i) from about 1 mg/mL to about 100 mg/mL of a low water soluble therapeutic agent, (ii) a cyclodextrin, and (iii) a polysorbate, a block copolymer of ethylene oxide and propylene oxide, a di-block copolymer of polyethylene oxide and polypropylene oxide, a tri-block copolymer of polyethylene oxide and polypropylene oxide, an ethoxylated emulsifier, a polyethylene glycol ester, sucrose laurate, tocopherol-polyethyleneglycol-succinate, a phospholipid, or a combination of two or more thereof;
wherein a ratio of the cyclodextrin to the therapeutic agent is from 1;
1 to 15;
1; and
wherein the formulation has a pH from about 7 to about 8.
- (i) from about 1 mg/mL to about 100 mg/mL of a low water soluble therapeutic agent, (ii) a cyclodextrin, and (iii) a polysorbate, a block copolymer of ethylene oxide and propylene oxide, a di-block copolymer of polyethylene oxide and polypropylene oxide, a tri-block copolymer of polyethylene oxide and polypropylene oxide, an ethoxylated emulsifier, a polyethylene glycol ester, sucrose laurate, tocopherol-polyethyleneglycol-succinate, a phospholipid, or a combination of two or more thereof;
Specification