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Ophthalmic gel containing travoprost and timolol and preparation method thereof

A technology of travoprost and ophthalmic gel, which is applied in the field of pharmaceutical preparations and can solve problems such as insufficient elasticity, decreased comfort, blurred vision, etc.

Active Publication Date: 2017-04-19
SHENYANG XINGQI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the inventors found that this type of polymer material has excess viscosity and insufficient elasticity. When the concentration is low, the viscosity of the preparation is low, and it is difficult to control the release of the drug and prolong the ocular residence time of the drug. Time is the key to reducing the eye irritation of this compound preparation and ensuring the efficacy of the drug; the concentration is higher, the viscosity of the preparation is higher, but the elasticity is poor, there is stringing, and the phenomenon of not dripping when used, resulting in inaccurate dosage, and after medication. Decreased comfort, resulting in blurred vision, greatly reducing the compliance of patients with medication

Method used

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  • Ophthalmic gel containing travoprost and timolol and preparation method thereof
  • Ophthalmic gel containing travoprost and timolol and preparation method thereof
  • Ophthalmic gel containing travoprost and timolol and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1－7

[0090] Embodiment 1-7: Preparation of ophthalmic gel 1-7

[0091] Prepare the ophthalmic gel of the present invention according to the corresponding prescription proportioning in Table 1.

[0092]Preparation method: (1) swell the prescription amount of hydroxypropyl methylcellulose, sodium carboxymethylcellulose and sodium hyaluronate with appropriate amount of water for injection, overnight, and set aside; (2) mix hypromellose matrix and carboxymethylcellulose The sodium matrix is ​​fully mixed and set aside; (3) get the prescription amount of travoprost and place it in a clean beaker, add the prescription amount HS15 solution, stir until completely dissolved, and set aside; (4) Take about 500g of water for injection at 50-60°C, dissolve the prescribed amount of timolol maleate, glycerin and phosphate in turn, stir well, (5) Add the solution of (3) to solution (4), and rinse the beaker (3) with a small amount of water for injection, merge the cleaning liquid into the mix...

experiment example 1

[0105] Experimental Example 1: Rheology Experiment

[0106] 1. Test drug

[0107] The ophthalmic gel samples prepared in Example 1 and Comparative Examples 1-3.

[0108] 2. Experimental method

[0109] The colloid properties and rheological properties of Example 1 and Comparative Example 1-3 are compared.

[0110] From the appearance of the preparation, the appearance of the gel preparation obtained in Example 1 is clear and transparent, and has suitable viscosity and elasticity. The preparations obtained in Comparative Example 1 and Comparative Example 3 had high viscosity and poor elasticity, and the preparations could not be dripped down. The preparation obtained in Comparative Example 2 has a clear appearance, but has a low viscosity.

[0111] The viscosity of Example 1 and Comparative Examples 1-3 was measured by rotational viscosity method (LVDV-II rotational viscometer 25°C 4# rotor).

[0112] 3. Experimental results

[0113] Such as figure 1 shown.

[0114] F...

experiment example 2

[0115] Experimental Example 2: Eye Irritation Test

[0116] 1. Purpose of the experiment:

[0117] Observe the irritation reaction of animals after eye administration of the ophthalmic gel of the present invention.

[0118] 2. Experimental animals:

[0119] New Zealand rabbits, weighing 2.0-2.5kg, male and female, provided by the Experimental Animal Center of Shenyang Pharmaceutical University. The test animals did not have any inflammatory reaction or eye damage.

[0120] 3. Test drugs:

[0121] The ophthalmic gel samples prepared in Example 1, Comparative Example 4 and Comparative Example 5.

[0122] 4. Experimental method:

[0123] Using the self-comparison method of the left and right sides of the same body, select 4 rabbits in each group, half male and half male, and check the eyes of each animal within 24 hours before the experiment. Animals with eye irritation symptoms, corneal defects and conjunctival damage cannot be used in the experiment. .

[0124] ⑴Single-...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and relates to an ophthalmic gel containing travoprost and timolol and a preparation method thereof. The invention also relates to the use of said ophthalmic gel. The ophthalmic gel of the present invention increases the residence time of the two active ingredients travoprost and timolol in the eye, reduces the loss of solution eye drops in the eye, improves bioavailability, and significantly improves the Ocular irritation of the drug and systemic side effects due to nasolacrimal drainage increase the stability of ingredients (bacteriostats) that have specific effects and are used in small amounts in the formulation.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an ophthalmic gel containing travoprost and timolol and a preparation method thereof. The invention also relates to the use of said ophthalmic gel. Background technique [0002] Glaucoma is a common chronic eye disease and the second leading cause of blindness in the world. Its main features are elevated intraocular pressure, optic nerve damage, and even vision loss in severe cases. The main types of glaucoma include primary (including open-angle and angle-avoidance), secondary, congenital, and mixed glaucoma. Among them, primary open-angle glaucoma is the most common, with about 3 million patients in the United States, and it is also one of the main causes of blindness in Western countries. [0003] The treatment of glaucoma is mainly to control intraocular pressure. The main drugs for lowering intraocular pressure are divided into five categories: including β-blockers...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/5575A61K31/5377A61K9/06A61P27/06A61P27/02
Inventor 刘继东杨宇春唐海张慧慧孙洋
Owner SHENYANG XINGQI PHARM CO LTD
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