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Ophthalmic solution containing diquafosol, method for producing same, and method for preventing formation of insoluble precipitate

A technology for diquafosol and eye drops, applied in the field of eye drops and preparation thereof, can solve the problems of increased preparation cost, clogging of filter filters, inability to remove precipitates, etc., and achieves stable physical and chemical properties and enhanced preservation efficiency. , excellent preservation effect

Inactive Publication Date: 2013-09-04
SANTEN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Especially for eye drops that generate precipitates during distribution or storage by patients, since the precipitates cannot be removed afterwards, they are not ideal as eye drops
In addition, when precipitates are generated during the preparation process, although the precipitates can be removed during the process of filter sterilization of the eye drops, the efficiency of filter sterilization will be deteriorated due to clogging of the filter filter during filtration. Issues such as increased preparation costs

Method used

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  • Ophthalmic solution containing diquafosol, method for producing same, and method for preventing formation of insoluble precipitate
  • Ophthalmic solution containing diquafosol, method for producing same, and method for preventing formation of insoluble precipitate
  • Ophthalmic solution containing diquafosol, method for producing same, and method for preventing formation of insoluble precipitate

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Experimental program
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Effect test

Embodiment

[0054] [Storage Stability Test]

[0055] Visually confirm whether there is any change in the properties of Diquafosol Eye Drops during storage, and at the same time study the effect of EDTA as a chelating agent on the change in properties.

[0056] (sample preparation)

[0057] · Prescriptions without EDTA

[0058] Dissolve 3 g of diquafosol sodium, 0.2 g of disodium hydrogen phosphate hydrate, 0.41 g of sodium chloride, 0.15 g of potassium chloride, and 0.0075 g of benzalkonium chloride in water to make it 100 mL, add a pH regulator to adjust the pH is 7.5, and the osmotic pressure ratio is 1.0.

[0059] Prescriptions containing 0.001 or 0.1% (w / v) EDTA

[0060] Dissolve 3 g of diquafosol sodium, 0.2 g of disodium hydrogen phosphate hydrate, 0.41 g of sodium chloride, 0.15 g of potassium chloride, 0.001 g or 0.1 g of sodium edetate hydrate and 0.002 g of benzalkonium chloride Make it 100 mL in water, and add a pH adjuster so that the pH becomes 7.5 and the osmotic pressur...

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Abstract

An ophthalmic solution containing diquafosol to which a chelating agent is added, wherein the formation of an insoluble precipitate during storage and a lowering in filtration performance in a production process (a filtration / sterilization process), said insoluble precipitate formation and said lowering in filtration performance being observed in conventional ophthalmic solutions containing diquafosol, are inhibited. It is also confirmed that the ophthalmic solution containing diquafosol to which a chelating agent is added shows an improved ability to retain the effect during storage. Therefore, the present invention provides an ophthalmic solution containing diquafosol, said ophthalmic solution having stable physicochemical properties in the course of production, distribution and storage by a patient, in particular, enabling efficient filtration / sterilization in the production process, and, moreover, having an excellent ability to retain the effect during storage. Also, the present invention provides a method for preventing the formation of an insoluble precipitate from an aqueous ophthalmic solution containing diquafosol or a salt thereof, said method comprising adding a chelating agent to the aqueous ophthalmic solution.

Description

technical field [0001] The invention relates to an eye drop and a preparation method thereof. The eye drop is an aqueous eye drop containing diquafosol (Diquafosol) or its salt at a concentration of 0.1-10% (w / v) (hereinafter referred to as Simply called "diquafosol ophthalmic solution"), the ophthalmic solution suppresses the generation of insoluble precipitates by containing a chelating agent. In addition, the present invention also relates to a method for suppressing generation of insoluble precipitates from an aqueous eye drop containing diquafosol or a salt thereof by adding a chelating agent to the aqueous eye drop. Background technique [0002] Diquafosol is a purinergic receptor agonist, also known as P 1 , P 4 - Di(uridine-5') tetraphosphate or Up 4 U, as disclosed in Patent No. 3652707 (Patent Document 1), is known to have an effect of promoting tear secretion. In addition, Cornea, 23(8), 784-792(2004) (Non-Patent Document 1) discloses that by administering eye...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7084A61K9/08A61K47/02A61K47/12A61K47/18A61K47/24A61P27/02
CPCA61K31/7084A61K9/0048A61K9/08A61K47/183A61K47/02A61K47/12A61P27/02A61P27/04A61K47/18A61K47/24
Inventor 坂谷明子池井辰夫稻垣孝司园田雅树福井阳子桑野光明
Owner SANTEN PHARMA CO LTD
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