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Tamsulosin orally disintegrating tablet composition with slow release performance

A technology for orally disintegrating tablets and tablets, applied to the preparation of tamsulosin hydrochloride orally disintegrating sustained-release tablet compositions with excellent pharmaceutical effects, and in the field of preparing tamsulosin medicaments, which can solve the problem of increasing the inoperability of the process And other issues

Active Publication Date: 2018-05-25
SHENZHEN WANHE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the need for extremely accurate temperature and humidity adjustment when processing tablets with temperature and humidity balance, very high temperatures are used when processing tablets at high temperature, which will greatly increase the inoperability of the process, and through this temperature and humidity balance treatment or high temperature treatment process Whether this will cause other problems for tablets is still unpredictable

Method used

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  • Tamsulosin orally disintegrating tablet composition with slow release performance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0229] Example 1: Preparation of Tamsulosin Hydrochloride Orally Disintegrating Tablets

[0230] (1) Dissolve 80 g of tamsulosin hydrochloride and 80 g of hydroxypropyl methylcellulose in 2000 g of purified water. Microcrystalline cellulose microparticles (Celphere102, Asahi Kasei, average particle diameter is about 120 μm, more than 95% particle diameter is in the range of 50-150 μm) 4000g is put into fluidized bed granulator, wraps with this solution with lateral spraying method Clothing to obtain tamsulosin hydrochloride particles.

[0231] The fluidized bed granulator above and in the context of the present invention is the WBF-60 fluidized bed granulator produced by Chongqing Yingge Granulation Coating Technology Co., Ltd. When using this fluidized bed granulator for granulation and / or coating, according to different materials, the spray speed can usually be controlled in the range of 10-120g / min, and the spray air pressure can usually be controlled in the range of 0.5-...

Embodiment 2

[0282] Example 2: Preparation of Tamsulosin Hydrochloride Orally Disintegrating Tablets

[0283] (1) Dissolve 80 g of tamsulosin hydrochloride and 80 g of hydroxypropyl methylcellulose in 2000 g of purified water. Put microcrystalline cellulose microparticles (Celphere102, Asahi Kasei, average particle diameter is about 160 μm, more than 95% particle diameter is in the scope of 100-250 μm) 4000g into fluidized bed granulator, use this solution to pack Clothing to obtain tamsulosin hydrochloride particles.

[0284] (2) Next, add 550 g of ethyl cellulose (ground and pass through a 200-mesh sieve) and 160 g of hydroxypropyl methylcellulose into 18,000 g of water, suspend the ethyl cellulose strongly and dissolve HPMC to obtain slow Release the coating suspension. Put 4000 g of tamsulosin hydrochloride particles into a fluidized bed granulator, and coat with the coating liquid by a side spraying method to obtain sustained-release pellets.

[0285] (3) Put 4000g of the slow-re...

Embodiment 3

[0298] Example 3: Preparation of Tamsulosin Hydrochloride Orally Disintegrating Tablets

[0299] (1) Dissolve 80 g of tamsulosin hydrochloride and 80 g of hydroxypropyl methylcellulose in 2000 g of purified water. Microcrystalline cellulose particles (Celphere102, Asahi Kasei, average particle diameter is about 80 μm, more than 95% of the particle diameter is in the range of 50-120 μm) 4000g is put into a fluidized bed granulator, and the solution is packaged with the side spray method. Clothing to obtain tamsulosin hydrochloride particles.

[0300] (2) Next, add 600 g of ethyl cellulose (ground and pass through a 200-mesh sieve) and 180 g of hydroxypropyl methylcellulose into 20,000 g of water, suspend the ethyl cellulose strongly and dissolve HPMC to obtain slow Release the coating suspension. Put 4000 g of tamsulosin hydrochloride particles into a fluidized bed granulator, and coat with the coating liquid by a side spraying method to obtain sustained-release pellets.

...

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Abstract

The invention relates to a tamsulosin orally disintegrating tablet composition with slow release performance. Concretely, the invention relates to an orally disintegrating tablet, which is a tablet obtained through pressing by using a tableting process. The tablet comprises a tablet base body and a plurality of coated micropills, wherein the tablet base body is prepared from a plurality of auxiliary materials; the coated micropills are basically uniformly dispersed in the tablet base body; the coated micropills comprise pill cores containing active ingredients and at least one layer of coatingcovering the surfaces of the pill cores. The invention further relates to a method for preparing the orally disintegrating tablet. The invention further relates to a method for improving the hardnessof the orally disintegrating tablet and improving the disintegrating performance. According to the method, the orally disintegrating tablet is pressed through a tableting process. The tablet comprises the tablet base body prepared from a plurality of auxiliary materials and a plurality of coated micropills basically uniformly dispersed in the tablet base bodies. The orally disintegrating tablet provided by the invention has excellent effects shown in the description in each aspect.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and relates to a preparation method of a highly selective α1A-receptor antagonist for treating benign prostatic hyperplasia, in particular to a method for preparing tamsulosin, more particularly to a A method for preparing an orally disintegrating sustained-release tablet composition of tamsulosin hydrochloride with excellent pharmaceutical effects. Background technique [0002] In order to improve the convenience of drug use and solve the medication compliance of specific indications and special patient populations, the pharmaceutical industry has developed a type of tablet that can be disintegrated into fine particles and accompanied by saliva to the stomach after being placed on the tongue. Such tablets are commonly referred to as orally disintegrating tablets or orally disintegrating tablets. These orally disintegrating tablets do not need to be chewed, swallowed whole, or taken with water....

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/52A61K31/18A61K47/38A61K47/02A61P13/08
CPCA61K9/0056A61K9/2009A61K9/2081A61K9/5042A61K9/5073A61K31/18
Inventor 刘晓燕唐振钦马俊高学琴
Owner SHENZHEN WANHE PHARMA
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