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Water-soluble multi-use eyedrops composition for treatment of dry eye syndrome containing rebamipide and method for solubilization and stabilization thereof

A rebamipide and water-soluble technology, which is applied in the field of water-soluble eye drop compositions, can solve problems such as the use of specific examples of preservatives that are not disclosed, and achieve the effects of outstanding dissolution stability and preservation ability and minimized side effects

Active Publication Date: 2020-01-03
DAEWOO PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] Korean Publication Patent No. 10-2014-0020289, No. 10-2014-0087030, Authorized Patent No. 10-1271959, Authorized Patent No. 10-1692578, etc. have repeatedly disclosed rebamipide suspension eye drops The prior art of using preservatives, but the above-mentioned documents relate to rebamipide suspension formulations, and the technical solution of using preservatives in rebamipide aqueous solution to stably maintain water solubility has not yet been solved
[0019] In addition, Korean Laid-Open Patent No. 10-2011-0027786 discloses that preservatives can be used, and a pH regulator selected from hydrochloric acid and citric acid can be used, but no specific examples of preservatives or the use of chelating agents are disclosed.

Method used

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  • Water-soluble multi-use eyedrops composition for treatment of dry eye syndrome containing rebamipide and method for solubilization and stabilization thereof
  • Water-soluble multi-use eyedrops composition for treatment of dry eye syndrome containing rebamipide and method for solubilization and stabilization thereof
  • Water-soluble multi-use eyedrops composition for treatment of dry eye syndrome containing rebamipide and method for solubilization and stabilization thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Add 90ml of distilled water, 0.04g of methylparaben, and 0.01g of propylparaben into a 200ml flask, heat to 100°C and stir to dissolve, then stir until the distilled water becomes cool.

[0073] 0.5 g of hydroxypropylmethylcellulose was added to the above solution for stirring and dissolving, and then 1.5 g of rebamipide was added for stirring to suspend.

[0074] 4.2 ml of 1N NaOH solution as a solubilizer was added dropwise to the above suspension while stirring, and the pH was adjusted from 10 to 11 to completely dissolve the rebamipide.

[0075] 0.3 g of aminocaproic acid and 2.45 g of D-sorbitol were added to the above solution for stirring, and the osmotic pressure was adjusted to 220 mOsmol / kg-240 mOsmol / kg.

[0076] 0.05 g of sodium edetate was added to the above solution for stirring and dissolving, and then 1N HCl solution was added dropwise to the obtained transparent solution to adjust the pH to pH 7 to pH 8.

[0077] Distilled water was added to the obtain...

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PUM

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Abstract

The present invention relates to a water-soluble multi-dose eyedrop composition for treating dry eye syndrome comprising rebamipide, and a method for solubilizing and stabilizing the same, and relatesto an eyedrop composition for treating dry eye syndrome which, by including a preservative and a chelating agent in a disposable water-soluble rebamipide-containing eyedrop, can remain stable withoutforming precipitates during storage, and is characterized by comprising ingredients that are safe to be used as a multi-dose eyedrop; and to a preparation method of the same.

Description

technical field [0001] The present invention relates to a water-soluble eye drop composition that can be used repeatedly for the treatment of dry eye and its solubilization and stabilization method, wherein, dissolving rebamipide in water for solubilization, and making it It is stable and contains preservatives and additives, so it has excellent preservation ability and therapeutic effect. [0002] The present invention provides an eye drop composition that can be used repeatedly, and its purpose is to treat dry eye syndrome with rebamipide aqueous solution. [0003] Korean published patent No. 10-2014-0020289, No. 10-2014-0087030, No. 10-2011-0027786, authorized patent No. 10-1271959, authorized patent No. 10-1692578, etc. have repeatedly disclosed Reba Preservatives are used in Pate eye drops, but the above-mentioned documents relate to rebamipide suspension preparations, and the technical solution of using preservatives in rebamipide aqueous solution to stably maintain wat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4704A61K47/14A61K47/18A61P27/02
CPCA61K9/0048A61K9/08A61K31/4704A61K47/14A61K47/183A61P27/02A61K47/12A61K47/26A61K47/38A61P27/04
Inventor 黄星宇尹是烈赵官衡池龙勋
Owner DAEWOO PHARMA IND
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