Orally disintegrating tablet containing fexofenadine or salts of fexofenadine, and preparation method thereof

A technology of orally disintegrating tablets and fexofenadine, which is applied in the direction of non-active ingredient medical preparations, pharmaceutical formulations, active ingredients of heterocyclic compounds, etc., can solve the problem of increased incidence of cardiotoxicity, poor selectivity, application limitations, etc. question

Inactive Publication Date: 2010-09-22
北京万全阳光医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Histamine H1 receptor antagonists are mainly used for allergic diseases. The first-generation diphenhydramine, chlorpheniramine, promethazine, etc. have poor selectivity to receptors and have obvious sedative and anticholinergic effects ; The second generation has terfenadine, astemizole, loratadine, cetirizine, etc., although the selectivity to the receptor is high, and the central adverse reaction is less, but some can induce severe cardiotoxicity and make the patient Sudden death, combined with liver drug enzyme inhibitors such as macrolide antibiotics (except azithromycin), imidazole antifungal drugs, the incidence of cardiotoxicity increases, so the application is still limited

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Preparation Process:

[0021] Disperse the acrylic resin E100 in the prescribed amount of 95% ethanol; after dispersing evenly, add the prescribed amount of fexofenadine hydrochloride, stir for 30 minutes to make it completely dissolve; evaporate at 50 degrees for about 3 hours to obtain fexofenadine hydrochloride Definite clathrate. Weigh the fexofenadine inclusion compound of prescription quantity, add mannitol, starch, ethyl cellulose and croscarmellose sodium in equal amounts and mix evenly; use starch slurry as binder to make soft material, 16-mesh granulation; blast drying at 50 degrees, granulation with 24-mesh sieve; add prescription amount of croscarmellose sodium starch and magnesium stearate, mix evenly; compress into tablets.

Embodiment 2

[0024] Preparation Process:

[0025] Disperse the acrylic resin E100 in the prescribed amount of 95% ethanol; after dispersing evenly, add the prescribed amount of fexofenadine hydrochloride, stir for 30 minutes to make it completely dissolve; evaporate at 50 degrees for about 3 hours to obtain fexofenadine hydrochloride Definite clathrate. Weigh the prescribed amount of fexofenadine inclusion compound, add mannitol, starch, ethyl cellulose and hydroxypropyl cellulose in equal amounts and mix evenly; use starch slurry as a binder to make a soft material, 16 mesh Granules; air-dried at 50 degrees, granulated with a 24-mesh sieve; plus the prescribed amount of croscarmellose sodium starch and magnesium stearate, mixed evenly; compressed into tablets.

Embodiment 3

1

[0029] Preparation Process:

[0030] Disperse the acrylic resin RSOP in the prescribed amount of 95% ethanol; after dispersing evenly, add the prescribed amount of fexofenadine hydrochloride, stir for 30 minutes to make it completely dissolve; rotate and evaporate at 50 degrees for about 3 hours to obtain fexofenadine hydrochloride Definite clathrate. Weigh the prescribed amount of fexofenadine inclusion compound, add mannitol, starch, ethyl cellulose and hydroxypropyl cellulose in equal amounts and mix evenly; use starch slurry as a binder to make a soft material, 16 mesh Granules; air-dried at 50 degrees, granulated with a 24-mesh sieve; plus the prescribed amount of hydroxypropyl cellulose and magnesium stearate, mixed evenly; compressed into tablets.

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PUM

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Abstract

The invention provides an orally disintegrating tablet containing fexofenadine or salts of fexofenadine, which is prepared by the inclusion technology. When main drugs and inclusions exist at a specific ratio, the tablet can effectively solve the problems of the taste and disintegration of the main drugs, is convenient for operating, transporting and storing, has wide application range and is suitable for large-scale production.

Description

technical field [0001] The invention provides an orally disintegrating tablet containing fexofenadine or a salt thereof. Background technique [0002] Histamine H1 receptor antagonists are mainly used for allergic diseases. The first-generation diphenhydramine, chlorpheniramine, promethazine, etc. have poor selectivity to receptors and have obvious sedative and anticholinergic effects ; The second generation has terfenadine, astemizole, loratadine, cetirizine, etc., although the selectivity to receptors is high and the central adverse reactions are few, but some can induce severe cardiotoxicity and make patients Sudden death, combined with liver drug enzyme inhibitors such as macrolide antibiotics (except azithromycin), imidazole antifungal drugs, the incidence of cardiotoxicity increases, so the application is still limited. [0003] In recent years, clinical studies have found that Fexofenadine, a metabolite of terfenadine, has antihistamine effects, has few adverse react...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/445A61K47/32A61P11/02A61P37/08A61P17/00
Inventor 张晓刘海丽郭夏
Owner 北京万全阳光医药科技有限公司
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