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Non-irritant ophthalmic composition containing cyclosporin, and convenient preparation method

A technology of cyclosporine and composition, which is applied in the field of ophthalmic compositions containing cyclosporine, can solve the problems of complicated equipment and increased preparation cost, and achieve the effects of improving solubilization, reducing irritation and reducing cost

Inactive Publication Date: 2018-05-11
KUKJE PHARMA IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, in the above-mentioned technique, since the solution of cyclosporine-dissolved propylene glycol and surfactant is mixed with pure water to which high frequency is applied, and after the solution is placed, the strong force is continued at a speed of 3,000 to 5,000 rpm. Stir for 5 to 10 minutes and apply shear force, so there is a problem that the equipment at the time of preparation is complicated and the production cost increases

Method used

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  • Non-irritant ophthalmic composition containing cyclosporin, and convenient preparation method
  • Non-irritant ophthalmic composition containing cyclosporin, and convenient preparation method
  • Non-irritant ophthalmic composition containing cyclosporin, and convenient preparation method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1. Preparation of nanoemulsion ophthalmic composition

[0032] Cyclosporine was dissolved in polyoxyl 40 stearate as a solubilizing agent according to the composition as shown in Table 1 below. The remaining excipients (ie, poloxamer 407, polyvinylpyrrolidone, propylene glycol, citric acid, sodium citrate) were dissolved in purified water. Pure water in which the above-mentioned excipients were dissolved was added to the polyoxyl-40 stearate in which the above-mentioned cyclosporine was dissolved, and stirred to prepare a nanoemulsion. Next, pure water is added so that the total weight of the total composition is less than 100 g. Next, NaOH or HCl aqueous solution was added to adjust the pH to 7.2 to 7.6, and then pure water was added to obtain a total weight of 100 g.

[0033] Table 1

[0034]

Embodiment 2

[0035] Example 2. Nanoemulsion composition by buffer type

[0036] As shown in Table 2 below, the nanoemulsion composition was prepared in a similar manner to Example 1 above by adjusting the type, amount, and ratio of the buffer.

[0037] Table 2

[0038]

Embodiment 3

[0039] Example 3. Nanoemulsion composition by thickener type

[0040] As shown in the following Table 3, the nanoemulsion composition was prepared in a method similar to that of Example 1 above by adjusting the type, amount, and ratio of the thickener.

[0041] table 3

[0042]

[0043]

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Abstract

Provided is an aqueous-medium ophthalmic composition containing: cyclosporin as an active ingredient; and a polyoxyethylene stearate as a solubilizing agent.

Description

technical field [0001] This invention relates to ophthalmic compositions containing cyclosporine. Background technique [0002] Dry eye syndrome has a high prevalence among the elderly population, and recently, the prevalence among young people is on the rise as the time spent on smart devices and computers increases. [0003] Therapeutic methods for dry eye are very limited. At present, only cyclosporine, diquafosol tetrasodium, and hyaluronic acid are actually known as drugs with therapeutic activity for dry eye. In particular, hyaluronic acid is not a A therapeutic agent, but closer to an adjuvant therapeutic agent. Among them, it is reported that cyclosporine can be widely used in mild to severe dry eye, and has high safety. [0004] However, it is known that cyclosporine is difficult to form into eye drops because of its very low solubility in water (0.004% w / w solubility). [0005] In order to solve these problems, a technique of preparing an emulsion using castor o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/14A61K38/13A61K9/00
CPCA61K47/34A61K47/14A61K38/13A61P27/04A61K9/0048A61K47/10A61K47/32A61K9/1075A61K47/12
Inventor 李东宇裵贤柱金永官
Owner KUKJE PHARMA IND CO LTD