Composition of long-acting oral pills of Yansuan Tanshuluoxin and its production

A composition and long-acting technology, applied in the direction of drug combination, amide active ingredients, pill delivery, etc., can solve the problems of lower raw material utilization rate, uneven gastric dissolution rate, difficult to adjust ion size, etc., to achieve uniform particle size distribution, Effect of small variation in gastric dissolution rate

Inactive Publication Date: 2007-01-17
可隆制药株式会社
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the method described in this patent is more difficult to adjust the desired ion size when granulating, so the obtained particles have a larger range of particle distribution from 0.1 to 1.5 mm as

Method used

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  • Composition of long-acting oral pills of Yansuan Tanshuluoxin and its production

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～3

[0023] The inner core of the tamsulosin hydrochloride depot pellet according to the present invention was manufactured from the composition of Table 1 below.

[0024]

API

weight

Example 1

Example 2

Example 3

Inside

nuclear

Tamsuloxin Hydrochloride

0.5

0.5

0.5

Utech L30D55

200

Su Lisi

200

Kollicoat SR30D

200

sodium alginate

0.875

0.875

0.875

triethyl citrate

6.05

6.05

6.05

sugar

337.375

337.375

337.375

Full amount

544.8

544.8

544.8

[0025] (1) First, dissolve 0.875 g of sodium alginate in 250 ml of purified water,

[0026] (2) In Example 1, Eudragit L30D-55 200g, Su Lisi 200g in Example 2, and kollicoat SR30D 200g in Example 3 were added to the (1) as release modifier in Example 1 and triethanol citric acid 6.05 respectively. to make the mix...

Embodiment 4

[0030] The inner core of the tamsulosin hydrochloride depot pellet according to the present invention was manufactured from the composition of Table 2 below.

[0031]

[0032] Example 4: Manufacturing the inner core in the same manner as in Example 1, except that polyethylene glycol 6000 6.05 g was used instead of triethanol citrate as a plasticizer.

Embodiment 5～6

[0034] The inner core of the tamsulosin hydrochloride depot pellet according to the present invention was manufactured from the composition of Table 3 below.

[0035]

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PUM

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Abstract

An orally taken long-acting small pill of tamsulosin hydrochloride is proportionally composed of a core, a tamsulosin hydrochloride layer, a first release regulating layer chosen from Youteqi L30D55, Sulisi and kollicoat SR3D, a release assistant layer chosen from alginic acid, microcrystalline fiber and carboxymethyl cellulose sodium, and a second release regulating layer chosen from ethylcellulose, Youteqi L100 and Youteqi S100. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to an oral long-acting small pill composition of tamsulosin hydrochloride with uniform gastric dissolution rate and a manufacturing method thereof. Background technique [0002] The chemical name of tamsulosin hydrochloride is (R)(-)-5-[2-[[2-(o-ethoxyphenoxy)ethyl]amino]-2-methoxybenzenesulfonamide hydrochloride, Molecular formula is C 20 h 28 N 2 o 5 S. Tamsulosin has the effect of cutting off adrenal α1A receptors, especially its hydrochloride (Tansulosin hydrochloride) has the effect of cutting off α1 receptors in the urethra and prostate, so by reducing the pressure of the prostate in the urethral pressure curve, it can improve Difficulty urinating due to an enlarged prostate. [0003] Regarding the prior art of tamsulosin hydrochloride long-acting preparations, Korean Patent Publication No. 1993-0007245 describes adding a release modifier to a mixture of a physiologically active substance and a unit form and granulatin...

Claims

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Application Information

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IPC IPC(8): A61K31/18A61K9/20A61K9/48A61P13/08
Inventor 方圭镐黄祐信朴浩石崔圭相李一揆尹悳溢黄东爀
Owner 可隆制药株式会社
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