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Atropine-containing aqueous composition

A technology of water-based composition and water-soluble polymer, which is applied in the direction of drug combination, active ingredients of heterocyclic compounds, medical preparations of non-active ingredients, etc., which can solve problems such as glare, hindrance of daily activities, and reduction of lens adjustment

Active Publication Date: 2019-02-05
SINGAPORE HEALTH SERVICES PTE +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Atropine ophthalmic solution, when instilled in the eye, relaxes the pupillary sphincter of the iris, thereby causing dilation of the pupil that can cause glare, which persists during the maintenance period of atropine ophthalmic solution, and also reduces lens accommodation leading to poor vision close range sensitivity
This may interfere with carrying out daily activities

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0168] The aqueous composition in Example 1 was prepared according to the formulation shown in Table 1. Specifically, 0.01 g of atropine sulfate hydrate, 0.32 g of hydroxyethylcellulose, 0.1 g of sodium dihydrogen phosphate, and 2.4 g of concentrated glycerin were dissolved in purified water. To the thus-obtained solution, appropriate amounts of hydrochloric acid and sodium hydroxide were added to adjust the solution to pH 5, and the total volume was adjusted to 100 ml.

Embodiment 2、3、 and comparative example 1～3

[0170] According to the formulation shown in Table 1, it carried out similarly to Example 1, and prepared the aqueous composition in Examples 2, 3, and Comparative Examples 1-3.

[0171]

[0172] (experiment method)

[0173] A single dose (50 μl volume) of each aqueous composition was instilled into one eye of the rabbits (4 eyes from 4 rabbits, or 6 eyes from 6 rabbits for each aqueous composition). The images of rabbit pupils before instillation and 1 hour after instillation were obtained by optical coherence tomography (OCT), and then analyzed by image analysis software to calculate the pupil area and pupil dilation ratio of rabbits. The pupil dilation ratio was calculated using the following formula:

[0174] Pupil expansion rate (%)=((b-a) / a)×100,

[0175] Wherein, a is the average value (mm 2 ), a is 16.8(mm 2 ), b is the value of the pupil area 1 hour after instillation.

[0176] (test results)

[0177] Table 2 shows the results in Examples 1-3 and Comparative ...

Embodiment 4～11

[0190] The aqueous compositions in Examples 4-11 were prepared according to the formulations shown in Table 3.

[0191] (experiment method)

[0192] A single dose (50 μl volume) of each aqueous composition was instilled into one eye of the rabbits (4 eyes from 4 rabbits, or 6 eyes from 6 rabbits for each aqueous composition). The image of the rabbit pupil 1 hour after instillation was obtained by optical coherence tomography (OCT), and then analyzed by image analysis software to calculate the pupil area of ​​the rabbit.

[0193] (test results)

[0194] Table 3 shows the results in Examples 4 to 11. In Table 3, each value is an average value of data from 4 cases or 6 cases.

[0195] The pupil dilating effect of each aqueous composition was evaluated based on the following criteria.

[0196] A: Pupil area is less than 30.0mm 1 hour after instillation 2 Case.

[0197] B: Pupil area is 30.0mm 1 hour after instillation 2 More than and less than 35.0mm 2 Case.

[0198] C: P...

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Abstract

Disclosed herein is an aqueous composition comprising 0.001 - 0.1 % (w / v) atropine or a salt thereof, a water-soluble polymer, and buffer (I), which is at a pH range of 6 or lower, wherein the buffer(I) is at least one selected from the group consisting of a phosphate buffer, an aminocarboxylate buffer, a carbonate buffer, an acetate buffer, a tartrate buffer, a borate buffer, and trometamol.

Description

technical field [0001] The present invention mainly relates to an aqueous composition comprising atropine or a salt thereof (hereinafter also simply referred to as "atropine"). Background technique [0002] Myopia, a type of refractive error, is the condition of the eye in which light entering the eye from a distance is focused in front of the retina instead of on it, causing images of objects to appear blurred. Myopia is known to be caused by the axial length of the eye (the length from the cornea to the retina) being longer than normal (axial myopia), or excessively high refractive power of the cornea or lens (refractive myopia). [0003] Atropine is known to have the property of preventing elongation of the axial length of the eye. For example, Patent Document 1 discloses that a composition comprising less than 0.025% of atropine can inhibit or prevent myopia progression. [0004] Atropine ophthalmic solution, on the other hand, is used as a mydriatic and reduces accomm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/46A61K47/02A61K47/10A61K47/12A61K47/18A61K47/26A61K47/38A61K9/08
CPCA61K9/0048A61K9/08A61K31/46A61P27/02A61P27/10A61K47/02A61K47/10A61K47/12A61K47/183A61K47/186A61K47/38A61K47/08A61P27/08
Inventor D·谭R·波尔曼浅田博之高桥恭平阪中浩二森本隆司藤泽丰实
Owner SINGAPORE HEALTH SERVICES PTE
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