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Composition for oral administration of tamsulosin hydrochloride and controlled release granule formulation comprising same

A technology of Tansylate hydrochloride and composition, which is applied in the direction of drug combination, medical preparation of non-active ingredients, drug delivery, etc., and can solve problems such as stability and release characteristics fluctuations

Active Publication Date: 2007-02-28
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the stability and release characteristics of these formulations can undesirably fluctuate with food retained within the gastrointestinal organ or with pH changes

Method used

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  • Composition for oral administration of tamsulosin hydrochloride and controlled release granule formulation comprising same
  • Composition for oral administration of tamsulosin hydrochloride and controlled release granule formulation comprising same
  • Composition for oral administration of tamsulosin hydrochloride and controlled release granule formulation comprising same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] 0.2 parts by weight of tamsulosin hydrochloride, 21.0 parts by weight of Kollicoat SR30D (BASF, polyvinyl acetate), 5.5 parts by weight of METOLOSE 90SH (water-soluble HPMC; viscosity: 100,000 cps) and 123.5 parts by weight of microcrystalline fibers The vegetable (granulation agent) is placed in a high-speed mixer, and an appropriate amount of water is added to it. The mixture is mixed for 10-15 minutes and processed in a wet mill to obtain the ground material, which is passed through a compression mold equipped with a 0.8mm mesh, and granulated by a spheroidizer to obtain the required granules.

Embodiment 2

[0042] Except for using 133.5 parts by weight of dibasic calcium phosphate as a granulating agent, the steps of Example 1 were repeated to obtain the desired granules.

Embodiment 3

[0044] Except for using 95.5 parts by weight of dibasic calcium phosphate dihydrate as a granulating agent, the steps of Example 1 were repeated to obtain the desired granules.

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PUM

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Abstract

A composition for oral administration of tamsulosin hydrochloride and a controlled release granule formulation comprising the same exhibited excellent stability and sustained release characteristics of tamsulosin hydrochloride regardless of pH changes for an extended period of time.

Description

Technical field [0001] The present invention relates to an oral composition of tamsulosin hydrochloride and a controlled-release granule preparation containing the composition, wherein the composition exhibits excellent stability and sustained release of tamsulosin hydrochloride. Background technique [0002] Currently, tamsulosin hydrochloride is used to treat benign prostatic hypertrophy, and many people try to develop a tamsulosin hydrochloride controlled-release preparation with good stability and extended release rate. For example, European Patent Publication No. 80341A discloses a controlled-release oral preparation of tamsulosin, which contains a variety of pharmaceutical preparations; Korean Patent Publication No. 1993-7245 discloses an oral controlled-release preparation containing the drug, Aggregate forming agents such as cellulose, chitin and chitosan and insoluble polymers. However, the stability and release characteristics of these formulations fluctuate undesirably...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/38A61K9/14A61K31/18A61P13/08A61K9/16
CPCA61K9/5042A61K9/1635A61K31/18A61K9/5047A61K9/1652A61K9/1611A61K9/5026A61K9/1623A61P13/08B41J2/17506B41J2/17556B41J2/17553
Inventor 禹钟守张熙哲
Owner HANMI PHARMA
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