Eye-drop preparation and use thereof

一种滴眼剂、制剂的技术，应用在含有效成分的医用配制品、药物输送、有机活性成分等方向，能够解决分解等问题，达到提高稳定性、降低药物反应、含量降低的效果

Active Publication Date: 2011-04-13
OTSUKA PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, latanoprost itself is a thermally unstable drug, and the drug is easily decomposed in ophthalmic solutions when the temperature is higher than normal temperature (25°C)

Method used

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  • Eye-drop preparation and use thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation Embodiment 1

[0041] Take by weighing 2g carteolol hydrochloride, 5.2mg latanoprost, 0.04g sodium dihydrogen phosphate dihydrate, 0.1g disodium hydrogen phosphate dodecahydrate and 0.54g sodium chloride, and in it Add about 80ml of purified water. The mixture was stirred while heating to about 60°C to dissolve. After returning it to room temperature, the resulting solution was made up to 100 ml by adding purified water thereto, thereby preparing an eye drop formulation with a pH of 6.8.

preparation Embodiment 2

[0043] An eye drop formulation having a pH value of 6.8 was prepared in the same manner as in Preparation Example 1 except that 5 mg of germine was added to the composition of Preparation Example 1.

preparation Embodiment 3

[0045] An eye drop preparation having a pH of 6.8 was prepared in the same manner as in Preparation Example 1 except that 20 mg of germilamine was added to the composition of Preparation Example 1.

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PUM

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Abstract

Disclosed is a technique for preventing the decomposition of latanoprost (a thermally unstable substance) contained in an eye-drop solution to stabilize the eye-drop solution. Specifically disclosed is an eye-drop preparation comprising latanoprost and carteolol hydrochloride. By adding carteolol hydrochloride to an eye-drop solution containing latanoprost which is a thermally unstable substance and is likely to be adhered on the surface of a container, it becomes possible to prevent the decomposition of latanoprost in the eye-drop solution and also prevent the loss of latanoprost caused by the adsorption of latanoprost on the surface of a container.

Description

technical field [0001] The invention relates to an eye drop preparation and its application. Background technique [0002] The chemical name of latanoprost is isopropyl-(Z)-7-[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5 -Phenylpentyl-cyclopentyl]-5-heptenoate, and is used as a prostaglandin analogue in the treatment of glaucoma. The route of administration of latanoprost is ocular instillation, and an ophthalmic solution containing 0.005% latanoprost is commercially available. However, latanoprost itself is a thermally unstable drug, and the drug is easily decomposed in an ophthalmic solution when the temperature is higher than normal temperature (25° C.). For this reason, ophthalmic solutions containing latanoprost must be stored in a cooler (2-8°C) environment under light-shielding conditions. Non-Patent Document 1 is an article reporting the stability of an ophthalmic solution containing latanoprost to temperature and light. [0003] For the ophthalmic solution con...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5575A61K31/4704A61P27/06A61P43/00
CPCA61K9/0048A61K31/5575A61K31/4704A61P27/06A61P43/00
Inventor 大西好尚石川真一
Owner OTSUKA PHARM CO LTD
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