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Method for preparing fexofenadine hydrochloride orally disintegrating tablet

A technology for fexofenadine hydrochloride and oral disintegrating tablets, which is applied in directions such as pharmaceutical formulations, medical preparations of inactive ingredients, and pill delivery, can solve the problems of increasing the difficulty of taking children's patients, and achieves high dissolution rate, The effect of fast disintegration time and long storage time

Active Publication Date: 2013-01-23
ZHEJIANG WAN SHENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Because fexofenadine hydrochloride orally disintegrating tablets are mainly suitable for patients with seasonal allergic rhinitis and chronic idiopathic urticaria in children aged 6 to 11, but the orally disintegrating fexofenadine hydrochloride obtained by the traditional preparation method Due to the solubility of the tablet in the mouth, the different proportions of the ingredients limit children's taking, which increases the difficulty of taking it for children.

Method used

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  • Method for preparing fexofenadine hydrochloride orally disintegrating tablet
  • Method for preparing fexofenadine hydrochloride orally disintegrating tablet
  • Method for preparing fexofenadine hydrochloride orally disintegrating tablet

Examples

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Embodiment 1

[0016] Embodiment 1: the process of preparing 1000 pieces of fexofenadine hydrochloride of 30mg / tablet

[0017] 1.1. Preparation process of granules for coating ( figure 1 )

[0018] 1.1.1. According to the prescription listed in Table 1 below, weigh various raw and auxiliary materials (except absolute ethanol) required for the preparation of fexofenadine hydrochloride wet granules, pass through a 100-mesh sieve, and mix evenly;

[0019] Table 1: Feed amount of each batch of wet granules

[0020]

[0021] *Removed during process

[0022] 1.1.2. Materials to be mixed in step 1.1.1: fexofenadine hydrochloride, microcrystalline cellulose (VIVAPUR® 101), sodium carboxymethyl starch and polyvinylpyrrolidone (povidone, Plasdone® K-29 / 32) Add it to the whole grain wet mixing granulator (purchased from Zhejiang Jianan Technology Co., Ltd., model LHS300), start shearing and mixing, the rotation speed of the stirring blade is 504rpm, the rotation speed of the granulation knife...

Embodiment 2

[0055] Example 2 At the same time, according to the Chinese patent application publication, the method disclosed in the publication number 10175679 is used to prepare Fexofer hydrochloride orally disintegrating tablets.

Embodiment 3

[0056] Example 3 At the same time, according to the Chinese patent application publication, the method disclosed in the publication number 101824646 was used to prepare Fexofer hydrochloride orally disintegrating tablets.

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Abstract

The invention provides a method for preparing a fexofenadine hydrochloride orally disintegrating tablet. The method comprises the following steps of: (1) providing component substances including fexofenadine hydrochloride, microcrystalline cellulose, sodium carboxymethyl starch, polyvidone and absolute ethyl alcohol in the mass ratio of 300:550:100:50:240; (2) adding the fexofenadine hydrochloride, microcrystalline cellulose, sodium carboxymethyl starch and polyvidone in the component substances, adding a mixture into a wet mixing pelletizer, and starting shearing and mixing, wherein the rotating speed of a stirring paddle is 504 revolutions per minute, the rotating speed of a pelletizing knife is 1,500 revolutions per minute, and the mixing time is 10 minutes; (3) adding absolute ethyl alcohol into a powdery mixture, and mixing continually under the condition that the rotating speed of a stirring paddle wheel is 756 revolutions per minute, the rotating speed of the pelletizing knife is 3,000 revolutions per minute to obtain wet particles; and (4) drying the obtained wet particles obtained in the step (3) in a half way.

Description

technical field [0001] The invention belongs to a method for preparing orally disintegrating tablets, in particular to a method for preparing fexofenadine hydrochloride orally disintegrating tablets. Background technique [0002] Because fexofenadine hydrochloride orally disintegrating tablets are mainly suitable for patients with seasonal allergic rhinitis and chronic idiopathic urticaria in children aged 6 to 11, but the orally disintegrating fexofenadine hydrochloride obtained by traditional preparation methods Due to the dissolvability of the tablet in the mouth, the different ratios of the ingredients limit children's taking, which increases the difficulty for children to take. This just needs to further improve the process of preparing fexofenadine hydrochloride orally disintegrating tablets, and increase children's compliance with taking the medicament. Contents of the invention [0003] In order to solve the above problems, the process of this product is implement...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/32A61K31/445A61K47/38A61K47/32A61P11/02A61P37/08A61P17/00
Inventor 单瑞平李永和杜军金璐
Owner ZHEJIANG WAN SHENG PHARMA CO LTD
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