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Formulations for treatment of ocular diseases or conditions

A technology of ocular diseases, therapeutic agents, applied in the field of preparations for the treatment of ocular diseases or conditions

Inactive Publication Date: 2010-09-08
SANTEN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Additionally, systemic delivery of therapeutic agents to treat posterior segment disease can have undesired side effects

Method used

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  • Formulations for treatment of ocular diseases or conditions
  • Formulations for treatment of ocular diseases or conditions
  • Formulations for treatment of ocular diseases or conditions

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-45

[0554] Example 1-45 - Preparation and Administration of Compositions Containing Rapamycin

[0555] The preparation and characterization of exemplary rapamycin-containing compositions, and their administration to New Zealand white rabbits are described in Mudumba et al., US 2006 / 0258698 A1 and WO 2006 / 102378 A2 (Examples 1-45 and its associated drawings are incorporated herein by reference).

Embodiment 46

[0556] Example 46 - Preparation and Characterization of Solutions Containing Rapamycin

[0557] About 320g ethanol with N 2 Rinse for about 10 minutes, then add about 40 g of sirolimus to the ethanol. The mixture was sonicated for about 20 minutes, at the end of which all the sirolimus had gone into solution, forming a stock solution of sirolimus. The dilution solvent was prepared by sonicating about 1880 g of PEG 400 for about 60 minutes, then flushing the solvent with nitrogen for about 10 minutes.

[0558] The sirolimus stock solution and PEG 400 were then rotated at about room temperature for about 10 minutes in a rotary evaporator to mix the stock solution and dilution solvent. After mixing the solution was flushed with nitrogen for about 10 minutes and blanketed with nitrogen for about 5 minutes. After the solution was flushed and flooded with nitrogen, about 240 g of excess ethanol was evaporated from the solution by increasing the temperature of the solution, mainta...

Embodiment 47

[0560] Example 47 - Preparation and Characterization of Solutions Containing Rapamycin

[0561] About 32g ethanol with N 2 Rinse for about 10 minutes, then add about 4 g of sirolimus to the ethanol. The mixture was sonicated for approximately 20 minutes, at the end of which all the sirolimus had gone into solution, thereby forming a stock solution of sirolimus. The dilution solvent was prepared by sonicating about 92 g of PEG 400 for about 60 minutes, then flushing the solvent with nitrogen for about 10 minutes.

[0562] The sirolimus stock solution and PEG 400 were then rotated at about room temperature for about 10 minutes in a rotary evaporator to mix the stock solution and dilution solvent. After mixing the solution was flushed with nitrogen for about 10 minutes and blanketed with nitrogen for about 5 minutes. After the solution was flushed and flooded with nitrogen, about 28 g of excess ethanol was evaporated from the solution by increasing the temperature of the solut...

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Abstract

Described herein are liquid formulations which deliver a variety of therapeutic agents, including but not limited to rapamycin, to a subject for an extended period of time; liquid formulations which form a non-dispersed mass when placed in an aqueous medium; nondispersed mass-forming liquid formulations which form a gel or gel-like substance in an aqueous medium; liquid formulations, comprising a therapeutic agent and polymers; and methods for delivering therapeutic agents to a subject for an extended period of time using the liquid formulations. The liquid formulation may be placed in an aqueous medium of a subject, including via intraocular or periocular administration, or placement proximate to a site of a disease or condition to be treated in a subject. A method may be used to administer rapamycin to treat or prevent angiogenesis, choroidal neovascularization, or age-related macular degeneration, or wet age- related macular degeneration.

Description

technical field [0001] Described herein are liquid formulations for treating, preventing, inhibiting, delaying the onset, or causing resolution of a disease or condition by delivering a therapeutic agent to a subject, including but not limited to, a human subject, including but not limited to Eye delivery of a liquid formulation comprising a therapeutic agent, including but not limited to rapamycin (sirolimus), to the eye of a human subject, including but not limited to, treats age-related macular degeneration (AMD) and macular edema. Non-limiting examples of liquid formulations include solutions, suspensions, and in situ gelling formulations. Background technique [0002] The retina of the eye contains the light-sensing cones and rods. In the center of the retina is the macula, which is about 1 / 3 to 1 / 2 cm in diameter. The macula provides detailed vision (especially in the center (fovea)) because of the higher density of cones. Blood vessels, ganglion cells, inner nuclea...

Claims

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Application Information

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IPC IPC(8): A01N43/42A61K9/00
CPCA61K31/436A61K9/0048A61K47/38A61K39/3955A61K47/34A61K9/7007A61K9/10A61K45/06A61K9/0051A61K9/08A61K47/06A61K9/1075A61K31/575A61K47/10A61K31/4184A61P27/02A61K2300/00
Inventor P·J·多S·穆登巴T·尼瓦焦利D·A·韦伯S·法鲁克S·K·塔哈
Owner SANTEN PHARMA CO LTD
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