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Formulations for ocular treatment

A technology of therapeutic agents and preparations, applied in the field of preparations for eye treatment

Inactive Publication Date: 2008-03-05
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 ocular treatment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0280] Example 1 - Preparation and characterization of self-emulsifying formulations containing rapamycin

[0281] 1.47% Rapamycin w / w was dissolved in 11.77% Ethanol w / w followed by gentle mixing with 43.44% Cremophor EL w / w and 43.44% Capmuls PG8 w / w. The formulation is translucent. When in contact with an aqueous medium such as water or the vitreous of a rabbit's eye, the formulation forms a microemulsion and becomes "cloudy" or "milky", as opposed to forming non-dispersed clumps.

Embodiment 2

[0282] Example 2 - Intravitreal injection of a self-emulsifying formulation containing rapamycin into the eye

[0283] 50 [mu]l of the formulation described in Example 1 was injected into the vitreous of New Zealand white rabbit eyes. The entire vitreous (including the area where the self-emulsifying formulation was injected) was homogenized and analyzed for remaining rapamycin concentrations at 1, 5, 24, 72 and 168 hours. The mean concentration in the vitreous was calculated by dividing the measured mass of rapamycin by the volume of the analyzed vitreous. The analysis was performed by liquid chromatography mass spectrometry (LCMS). Each time point represents the average of two individual eyes of two rabbits (four eyes per time point).

[0284] The mean concentrations of rapamycin were about 347, about 401, about 273, about 18, and about 1 μg / μl at 1, 5, 24, 72, and 168 hours, respectively. These results are shown in Figure 1.

Embodiment 3

[0285] Example 3 - Preparation and characterization of self-emulsifying formulations containing rapamycin

[0286] Rapamycin was dissolved in 100% ethanol followed by gentle mixing with Caprol MPGO and Softigen767. The final percentages by total weight were 2% w / w Rapamycin, 4% w / w Ethanol, 47% w / w Caprol MPGO and w / w 47% Softigen767.

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Abstract

Diseases and conditions associated with tissues of the body, including tissues in the eye, can be effectively treated by administering therapeutic agents to those tissues. Described herein are self-emulsifying formulations and methods for delivering therapeutic agents to such tissues. A self-emulsifying formulation may be delivered to an aqueous medium of a subject, including but not limited to the vitreous. A method may, for instance, be used to administer rapamycin or related compounds to treat or prevent choroidal neovascularization associated with age-related macular degeneration, or to treat dry AMD. A self-emulsifying formulation may also be administered systernically, such as orally, to treat transplant rejection in a subject. A self-emulsifying formulation may comprise rapamycin, related compounds, or other therapeutic agents.

Description

technical field [0001] Described herein are methods of treating ocular diseases and disorders by delivering a therapeutic agent, particularly age-related macular degeneration ("AMD") by delivering a self-emulsifying formulation comprising rapamycin to a subject or an eye of a subject and self-emulsifying formulations. [0002] Cross-references to related applications [0003] This application is related to U.S. Provisional Patent Application Serial No. 60 / 664,040 filed March 21, 2005 entitled "Liquid Formulations For Treatment Of Diseases Or Conditions," and filed March 21, 2005 entitled "In Situ Gelling Formulations And Liquid Formulations For Treatment of Diseases Or Conditions," U.S. Provisional Patent Application Serial No. 60 / 664,306, and U.S. Provisional Patent Application Serial No. 60 / 651,790, filed February 9, 2005, entitled "Formulations For Ocular Treatment," are related and claim their priority, each material is incorporated herein by reference in its entirety fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/44
Inventor P·J·M·多尔S·穆德姆巴T·尼瓦焦利D·A·韦伯
Owner SANTEN PHARMA CO LTD
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