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Liquid preparation for dosing nasal cavities and method for making the same

A liquid preparation and nasal administration technology, applied in the field of medicine, can solve the problems of poor patient compliance and slow onset of action

Inactive Publication Date: 2010-03-17
广州达信生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Currently, the commercially available rupatadine is in the form of oral administration such as tablets or capsules. Drugs have the disadvantages of slow onset of drug absorption and poor patient compliance

Method used

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  • Liquid preparation for dosing nasal cavities and method for making the same
  • Liquid preparation for dosing nasal cavities and method for making the same
  • Liquid preparation for dosing nasal cavities and method for making the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Example 1 Preparation of Rupatadine Nasal Spray

[0056] Main drug and excipient name dosage

[0057] Rupatadine 0.625g

[0058] Sulfobutyl ether-β-cyclodextrin 1.50g

[0059] 5% Benzalkonium Bromide 0.20mL

[0060] Appropriate amount of distilled water, and add to 100mL

[0061] Preparation method: Dissolve sulfobutyl ether-β-cyclodextrin and 5% benzalkonium bromide in about 90mL of water, then add rupatadine, dissolve it by ultrasonication, add distilled water to 100mL, micropores of 0.45μm Filtrate through a filter membrane and sterilize by circulating steam to obtain the medicinal liquid of rupatadine nasal spray, with a pH of 4.5-5.0. It is obtained by distributing the above-mentioned medicinal liquid into a multi-dose delivery device.

Embodiment 2

[0062] The preparation of embodiment 2 rupatadine nasal drops

[0063] Main drug and excipient name dosage

[0064] Rupatadine 25.0g

[0065] Chlorobutanol 0.50g

[0066] Sodium Glycocholate 0.05g

[0067] Potassium dihydrogen phosphate 0.56g

[0068] Sulfobutyl ether-β-cyclodextrin 30.0g

[0069] Potassium hydroxide appropriate amount, adjust pH to 4.5

[0070] Appropriate amount of distilled water, and add to 100mL

[0071] Preparation method: Put potassium dihydrogen phosphate, sodium glycocholate, and chlorobutanol in a beaker, add 90 mL of distilled water to dissolve, and adjust the pH to 4.5-5.0 with potassium hydroxide solution. Add sulfobutyl ether-β-cyclodextrin to the above solution and mix evenly, slowly add rupatadine and ultrasonically dissolve it, and add distilled water to 100 mL. Filter through a 0.45 μm microporous membrane and sterilize by circulating steam to obtain the medicinal solution of rupatadine nasal drops. It is obtained by distributing the ab...

Embodiment 3

[0072] Example 3. Preparation of Rupatadine Nasal Spray

[0073] Main drug and excipient name dosage

[0074] Rupatadine 0.38g

[0075] Dimethyl-β-cyclodextrin 2.50g

[0076] Ethylparaben 0.50g

[0077] Distilled water to 100mL

[0078] Preparation method: Dissolve ethylparaben and dimethyl-β-cyclodextrin in 90mL water, then add rupatadine, dissolve it by ultrasonication, add distilled water to 100mL, filter through a 0.45μm microporous membrane, Sterilization by circulating steam to obtain the medicinal solution of rupatadine nasal spray, the measured pH is 4.5-5.0. It is obtained by distributing the above-mentioned medicinal liquid into a multi-dose delivery device.

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Abstract

The invention relates to a liquid preparation for dosing nasal cavities, which comprises 0.1 to 25 g / 100 mL of rupatadine and 0.5 to 30 g / 100 mL of cyclodextrin compound. The invention also relates toa method for making the liquid preparation. The liquid preparation of the invention has the characteristics of convenient use, high patient compliance and rapid absorption speed after dosing.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a liquid preparation containing rupatadine for nasal administration and a preparation method thereof. Background technique [0002] Allergic rhinitis, also known as allergic rhinitis, is a common and frequently-occurring disease. It can be divided into two types: seasonal rhinitis and perennial rhinitis. The main symptoms are sneezing, runny nose, nasal congestion and nasopharyngeal itching, etc. . With the progress of industrialization, the drastic changes of modern lifestyle and human ecological environment, the incidence of allergic rhinitis has a global increase trend, and its incidence accounts for about 5-50% of the population. my country reported in 1998 that the prevalence of allergic rhinitis was 6.32%. According to this calculation, there are now more than 80 million patients. Allergic rhinitis is the starting point of airway diseases such as asthma, COPD, and bronchiectasis. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K47/48A61K31/4545A61K47/40A61P37/08A61P11/02A61K47/61
Inventor 阴元魁雍智全谭培陈宝林胡文慧韩为跃闻亚磊
Owner 广州达信生物技术有限公司
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