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Pharmaceutical composition of olopatadine or salts of olopatadine, and preparation method thereof

A technology for olopatadine and composition, which is applied in the field of pharmaceutical compositions of olopatadine or its salts and its preparation field, can solve problems such as eye damage, adverse reactions of antihistamine active substances and the like, and achieve irritant Small size, long surface residence time, and improved bioavailability

Inactive Publication Date: 2013-07-17
JIANGSU YABANG AIPUSEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This has caused two problems, one is the damage to the eye caused by the use of preservatives in conventional eye drops, and the other is the adverse reaction of antihistamine active substances

Method used

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  • Pharmaceutical composition of olopatadine or salts of olopatadine, and preparation method thereof
  • Pharmaceutical composition of olopatadine or salts of olopatadine, and preparation method thereof
  • Pharmaceutical composition of olopatadine or salts of olopatadine, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Preparation prescription of the present invention is made up of following components:

[0015]

[0016] Preparation Process:

[0017] 1) Under sterile conditions, fully swell Carbomer and an appropriate amount of water for injection at room temperature to obtain solution 1;

[0018] 2) After dissolving olopatadine hydrochloride and benzalkonium chloride with appropriate amount of water for injection respectively, they are combined to obtain solution 2;

[0019] 3) Dissolving mannitol, sodium chloride, edetate disodium, and poloxamer in an appropriate amount of water for injection in sequence to obtain solution 3;

[0020] 4) Combine Solution 1, Solution 2, and Solution 3 under sterile conditions, mix them evenly through a high-speed homogenizer, adjust the pH value to 5-7 with 1M sodium hydroxide solution, and add water for injection to the total amount;

[0021] 5) After sterilization, cool to room temperature, and dispense into sterilized eye drop bottles under ...

Embodiment 2

[0023] Preparation prescription of the present invention is made up of following components:

[0024]

[0025] Preparation Process:

[0026] 1) Under sterile conditions, polycarbophil and an appropriate amount of water for injection are fully swollen at room temperature to obtain solution 1;

[0027] 2) After dissolving olopatadine hydrochloride and benzalkonium bromide in appropriate amount of water for injection respectively, they are combined to obtain solution 2;

[0028] 3) Dissolving mannitol, sodium chloride, disodium edetate and polysorbate 80 in an appropriate amount of water for injection in sequence to obtain solution 3;

[0029] 4) Combine Solution 1, Solution 2, and Solution 3 under sterile conditions, mix them evenly through a high-speed homogenizer, adjust the pH value to 5-7 with 1M sodium hydroxide solution, and add water for injection to the total amount;

[0030] 5) After sterilization, cool to room temperature, and dispense into sterilized eye drop bo...

Embodiment 3

[0031] Embodiment 3: Rabbit eye residence time experiment

[0032] Objective: The length of ocular residence time is an important index to measure ophthalmic sustained-release eye drops. The residence time in the eyes of rabbits was compared.

[0033] Preparation of the test product: Add 0.05% sodium fluorescein to the product prepared in Example 1 and Example 2 and commercially available Patanol (olopatadine hydrochloride eye drops, Alcon Company) .

[0034] Method: 18 healthy rabbits were selected and divided into three groups on average. The rabbits were fixed with their heads, their lower eyelids were lifted, and the conjunctival sac was pulled into a ring shape, and fluorescein was dripped into the conjunctival sacs of the left eyes of the three groups of rabbits respectively. 20 μL each of the sodium product of Example 1, Example 2, and commercially available Patanol was dropped into 20 μL of Patanol containing fluorescein sodium as a control group. After administrati...

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PUM

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Abstract

The invention discloses a pharmaceutical composition of olopatadine or salts of olopatadine for treating allergic conjunctivitis, and a preparation method thereof. The composition mainly comprises the olopatadine or the salts of the olopatadine, and polycarbophil or polycarbophil salt or carbomer. The preparation method comprises firstly fully swelling the polycarbophil or the polycarbophil salt or the carbomer with a proper amount of pure water, and secondly adding the olopatadine or the salts of the olopatadine and other accessories.

Description

technical field [0001] The invention relates to a pharmaceutical composition of olopatadine or a salt thereof for treating allergic conjunctivitis and a preparation method thereof Background technique [0002] A doxepin derivative represented by olopatadine is a mast cell stabilizer with antihistamine activity. For the prevention or treatment of allergic eye disease. The marketed product Olopatadine Hydrochloride Eye Drops, the trade name is Patanol, its ingredients are mainly composed of Olopatadine Hydrochloride, bacteriostatic agent, and pH regulator. 3 to 4 times a day, once every 6 to 8 hours. Its side effects include headache, fatigue, blurred vision, burning or stinging sensation, cold syndrome, dry eyes, foreign body sensation, congestion, allergies, keratitis, eyelid edema, nausea, pharyngitis, itching, rhinitis, sinusitis, and taste perversion Wait. As conventional sterile pure aqueous eye drops, due to the existence of the corneal barrier, the inversion of tea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/335A61K47/32A61P27/02
Inventor 王淑娟陈再新赵晓红毛白杨蒋建中徐丽洁庄鹏飞孙海棠王丞陆文娟刘雯
Owner JIANGSU YABANG AIPUSEN PHARMA
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