Title:
NOVEL EYE DROP COMPOSITION FOR TREATING DRY EYE SYNDROME CONTAINING REBAMIPIDE AND METHOD FOR SOLUBILIZING AND STABILIZING SAME
Document Type and Number:
WIPO Patent Application WO/2019/059479
Kind Code:
A1
Abstract:
The present invention relates to an eye drop composition for treating dry eye syndrome, characterized in that the eye drop composition remains stable during storage without precipitation occurring and contains a safe ingredient for use as an eye drop, by solubilizing rebamipide that is a poorly soluble compound, and a method for producing the same. The eye drop composition for treating dry eye syndrome of the present invention includes a base for solubilizing rebamipide, and is characterized by containing a stabilizer for maintaining a supersaturated stabilized state, a specific type of buffer for maintaining biocompatible pH of 7 to 8 and an osmotic agent. A method for producing the same comprises the steps of: adding a base to rebamipide or a pharmaceutically acceptable salt thereof and a stabilizer and dissolving the same in water to obtain an aqueous eye drop solution of pH of 10 to pH of 11; adding at least one osmotic agent selected from a buffer and a nonionic osmotic agent to the eye drop solution and dissolving the same; and after adjusting the pH to 7 to 8 with an acid, filtering the solution with a syringe filter to make the same sterile. The produced eye drop is in the form of an aqueous solution, is stable when frozen, refrigerated, and at room temperature, and includes a therapeutic agent for dry eye syndrome which is stable even when cross-stored in a refrigerator or at room temperature, or at a refrigerating temperature or room temperature.
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Inventors:
JEON SUN-DUCK (KR)
HWANG SUNG-WOO (KR)
YOON SI-YEOL (KR)
CHO KWAN-HYUNG (KR)
KIM JAE-YEOL (KR)
JI YOUNG-HOON (KR)
HWANG SUNG-WOO (KR)
YOON SI-YEOL (KR)
CHO KWAN-HYUNG (KR)
KIM JAE-YEOL (KR)
JI YOUNG-HOON (KR)
Application Number:
PCT/KR2018/003300
Publication Date:
March 28, 2019
Filing Date:
March 21, 2018
Export Citation:
Assignee:
DAEWOO PHARMACEUTICAL IND CO LTD (KR)
International Classes:
A61K9/00; A61K31/4704; A61K47/26; A61K47/38
Domestic Patent References:
| WO2008074853A1 | 2008-06-26 |
Foreign References:
| KR20070092965A | 2007-09-14 | |||
| JP2015531338A | 2015-11-02 | |||
| JP2016179960A | 2016-10-13 | |||
| KR101692578B1 | 2017-01-03 |
Attorney, Agent or Firm:
HANSUNG INTELLECTUAL PROPERTY (KR)
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