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Liquid formulations for ocular treatment

A technology of liquid preparation, rapamycin, applied in sensory diseases, allergic diseases, cardiovascular system diseases, etc.

Active Publication Date: 2014-11-19
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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  • Liquid formulations for ocular treatment
  • Liquid formulations for ocular treatment
  • Liquid formulations for ocular treatment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0431] Example 1 - Preparation and Characterization of Rapamycin-Containing Solutions

[0432] 1.256% rapamycin (percentage of total weight) was dissolved in 9.676% ethanol (percentage of total weight). A 15% aqueous solution of F127 (Lutrol) in sterile water was slowly added with constant stirring. The final concentration was about 78.57% sterile water (percentage of total weight) and about 10.50% F127 (Lutrol) (percentage of total weight). This solution is listed in Table 1 as Formulation #32. The solution was kept at 2°C until use.

Embodiment 2

[0433] Example 2 - Subconjunctival injection of a solution containing rapamycin

[0434] 50 µl of the solution described in Example 1 was injected between the sclera and conjunctiva of New Zealand white rabbits.

[0435] figure 2 The log scale mean concentrations of rapamycin present in the vitreous (ng / ml), retinachoroid (ng / mg) and sclera (ng / mg) 20, 40, 67 and 90 days after injection are depicted.

[0436] Analysis was performed by liquid chromatography mass spectrometry (LCMS) using an internal standard.

[0437] At each time point, the mean concentration of rapamycin was calculated by summing the obtained rapamycin concentrations per eye for each rabbit and dividing the number of eyes analyzed by the total amount. In this experiment, each time point represents the average of two individual eyes of two rabbits (four eyes at the time point) or the average of both eyes of one rabbit (two eyes at the time point).

[0438] Whole vitreous bodies were homogenized and analyze...

Embodiment 3

[0444] Example 3 - Preparation and Characterization of Rapamycin-Containing Solutions

[0445] 5.233% rapamycin (% of total formulation weight after addition of all ingredients) was dissolved in 0.4177g EtOH; the amount of EtOH was reduced to 0.1296g (6.344%, w / w) by forced evaporation (heating). Add PEG400 with constant stirring. The final concentrations as total weight percentages are about: rapamycin 5.233%, ethanol 6.344% and PEG4008 8.424%. On contact with the vitreous, the formulation forms non-dispersed masses relative to the surrounding medium. This solution is listed in Table 1 as Formulation #34.

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Abstract

Described herein are liquid rapamycin formulations. Described herein are methods of treating or preventing diseases or conditions, such as choroidal neovascularization, wet AMD and dry AMD, and preventing transition of dry AMD to wet AMD, using the liquid rapamycin formulations described herein.

Description

[0001] The present invention is a divisional application of an invention patent with the application number 200680008018.X, the application date being February 9, 2006, and the invention name being liquid preparations for treating diseases or diseases. technical field [0002] 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 A liquid formulation comprising a therapeutic agent is delivered to the eye of a human subject, including but not limited to, to treat age-related macular degeneration (AMD). Non-limiting examples of such liquid formulations include solutions, suspensions, and gel-in-situ formulations. [0003] Cross-reference with related applications [0004] This application is related to U.S. Provisional Patent Application Serial No. 60 / 664,040, file...

Claims

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Application Information

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IPC IPC(8): A61K31/436A61K47/34A61P9/10
CPCA61K31/436A61K47/44A61K31/045A61K47/10A61K31/4745A61K9/0048A61K31/44A61K47/12A61K9/0019A61P27/02A61P27/08A61P37/06A61P9/10A61K9/0046
Inventor S·穆德姆巴P·JM·多尔T·尼瓦焦利D·A·韦伯S·M·法鲁克
Owner SANTEN PHARMA CO LTD
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