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Orally disintegrating tablet pharmaceutical composition comprising tamsulosin and dutasteride

A technology for oral disintegrating tablets and dutasteride, which is applied in the directions of drug combination, drug delivery, medical preparations containing active ingredients, etc., and can solve problems such as troublesome preparation process and the like

Active Publication Date: 2021-02-02
SHENZHEN WANHE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, because dutasteride soft capsules are oily soft capsules, the preparation process is cumbersome.

Method used

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  • Orally disintegrating tablet pharmaceutical composition comprising tamsulosin and dutasteride
  • Orally disintegrating tablet pharmaceutical composition comprising tamsulosin and dutasteride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0289] Example 1: Preparation of Tamsulosin Hydrochloride-Dutasteride Orally Disintegrating Tablets

[0290] (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.

[0291] Separately, 100 g of dutasteride and 80 g of hydroxypropylmethylcellulose were dissolved 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 dutasteride part...

Embodiment 2

[0346] Example 2: Preparation of Tamsulosin Hydrochloride-Dutasteride Orally Disintegrating Tablets

[0347] (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.

[0348] Separately, 100 g of dutasteride and 80 g of hydroxypropylmethylcellulose were dissolved 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 dutasteride particles.

[0349] (2) Next, ad...

Embodiment 3

[0364] Example 3: Preparation of Tamsulosin Hydrochloride-Dutasteride Orally Disintegrating Tablets

[0365] (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.

[0366]In addition, dutasteride particles were prepared by referring to step (1) of Example 2.

[0367] (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 g...

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Abstract

The present invention relates to an orally disintegrating tablet pharmaceutical composition comprising tamsulosin and dutasteride. It specifically relates to an orally disintegrating tablet, which is a tablet compressed by a tableting process; the tablet includes a tablet matrix composed of various auxiliary materials, and two One kind of coated pellets; the two kinds of coated pellets respectively include a pellet core containing two different active ingredients and at least one layer of coating covering the surface of the pellet core. The invention also relates to a preparation method of the orally disintegrating tablet and its corresponding use. The orally disintegrating tablet of the present invention exhibits the excellent technical effect described in the description of the present invention.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and relates to a method for preparing a medicament for treating benign prostatic hyperplasia, in particular to a method for preparing a medicament containing tamsulosin and dutasteride, and more particularly to a method for preparing A method for an orally disintegrating tablet composition of tamsulosin hydrochloride and dutasteride having excellent pharmaceutical effects. The tamsulosin is a highly selective α1A-receptor antagonist, and the dutasteride is a selective inhibitor of steroid 5-α reductase type 1 and type 2 subtypes. 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 com...

Claims

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Application Information

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IPC IPC(8): A61K31/58A61K9/22A61K9/50A61K47/02A61P13/08A61K31/18
CPCA61K9/0056A61K9/2009A61K9/5026A61K9/5042A61K31/18A61K31/58A61K2300/00
Inventor 衷期群马俊刘晓燕唐振钦
Owner SHENZHEN WANHE PHARMA
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