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Timolol maleate (TM) eye gel and preparation method thereof

A gel, acid thiol technology, applied in the field of timolol maleate preparations, can solve the problems of preservative irritation, short retention time, short retention time of the drug in the eye, etc., and achieves good sustained-release effect, The effect of reducing the dosage and improving the safety of the drug

Active Publication Date: 2013-01-02
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN101474146 discloses a timolol maleate eye drop without bacteriostatic agent and its preparation method, but the patent is a solution type eye drop, which does not solve the problem of short retention time of the drug in the eye
In a word, none of the above-mentioned products and patents can simultaneously solve the short retention time of timolol maleate eye drops in the eyes and the irritating problems of long-term use of preservatives

Method used

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  • Timolol maleate (TM) eye gel and preparation method thereof
  • Timolol maleate (TM) eye gel and preparation method thereof
  • Timolol maleate (TM) eye gel and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036]

[0037]

[0038] Soak hypromellose E4M and Carbopol 971 in 30 grams of water for injection respectively, stir to obtain a solution, and set aside.

[0039] Timolol maleate, mannitol and EDTA-2Na are added with 30 grams of water for injection, dissolved under stirring, and filtered through a microporous membrane.

[0040] The filtrate is added to the hypromellose and carbopol solution prepared above, adding a NaOH solution with a weight concentration of 10% to adjust the pH of the system to 6.5, and adding water for injection to a total weight of 100 grams, stirring evenly , irradiation sterilization to obtain timolol maleate ophthalmic gel.

Embodiment 2

[0042]

[0043] The preparation method is the same as in Example 1.

Embodiment 3

[0045]

[0046] The preparation method is the same as in Example 1.

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Abstract

The invention provides timolol maleate (TM) eye gel and a preparation method thereof. One hundred grams of the eye gel comprises the following components by weight: 0.10-0.70g of TM, 0.10-2.0g of gel matrix, 0.2-5.0g of osmotic pressure regulator and the balance of water, wherein the gel matrix is a mixture of cellulose derivatives and carbopol and the weight ratio of cellulose derivatives to carbopol is 1:0.02-1, the cellulose derivatives comprise more than one of methylcellulose, hydroxymethyl cellulose, hydroxypropyl methylcellulose (HPMC) and carboxymethyl cellulose (CMC), and the carbopol comprises one of polyacrylic acid (PAA), polyacrylate or crosslinking polyacrylic resin. Patients with glaucoma and ocular hypertension use the controlled-release TM eye preparation once a day; and the prescription of the eye preparation is free of preservatives, thus lowering stimulation to eyes and improving medication safety if the gel is used for a long term.

Description

technical field [0001] The present invention relates to timolol maleate preparations. Background technique [0002] Timolol maleate is a non-selective β-adrenoceptor blocker, has no obvious endogenous sympathomimetic activity and local anesthetic effect, and has no direct inhibitory effect on the myocardium. Timolol maleate eye drops is one of the most commonly used drugs for the treatment of glaucoma. It can reduce intraocular pressure in patients with high intraocular pressure and normal people. It is suitable for primary open-angle glaucoma, secondary glaucoma, Ocular hypertension and some primary angle-closure glaucoma. This product can also be used for the treatment of glaucoma that is ineffective by other drugs or surgery. However, when the dosage of timolol eye drops is too large or the system is absorbed more, it will also produce obvious systemic side effects, such as bradycardia, arrhythmia, and bronchospasm. [0003] The intraocular pressure-lowering effect of ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K31/5377A61K47/38A61K47/32A61P27/06
Inventor 侯惠民王健
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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