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Extended-release tablets containing alfuzosin hydrochloride

A technology of alfuzosin hydrochloride and sustained-release tablets, which can be applied to medical preparations containing active ingredients, pill delivery, and medical preparations with non-active ingredients, etc., and can solve problems such as delay time

Inactive Publication Date: 2016-06-01
AHN GOOK PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, it has a lag-time problem in the discharge mode

Method used

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  • Extended-release tablets containing alfuzosin hydrochloride
  • Extended-release tablets containing alfuzosin hydrochloride
  • Extended-release tablets containing alfuzosin hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～5

[0030] Alfuzosin hydrochloride, hydroxypropyl methylcellulose 2208 (HPMC2208, Methocel K100MCRPremium), hydrogenated castor oil (Lubri-wax) and iron oxide were mixed according to the composition ratio of the upper layer described in Table 1 below, and stearyl alcohol and ethyl alcohol were added. Base cellulose (Ethocel100cpSTD.PREM.) Combination solution, and implement wet granulation process. The granules are dried to make a granule dosage form. Here, polyethylene oxide, magnesium stearate, and hard anhydrous silicic acid were mixed to prepare an upper layer composition.

[0031] Next, after mixing alfuzosin hydrochloride, microcrystalline cellulose, hydroxypropyl cellulose-H (HPC-H) and iron oxide according to the composition ratio of the lower layer described in Table 1 below, stearyl alcohol was added and wet preparation was carried out. grain process. The granules are dried to make a granule dosage form. Here, polyethylene oxide, low-substituted hydroxypropyl cellulos...

Embodiment 6～10

[0038]

[0039]

[0040]

[0041]Alfuzosin hydrochloride, hydroxypropyl methylcellulose 2208 (HPMC2208, Methocel K100MCRPremium), hydrogenated castor oil (Lubri-wax) and iron oxide were mixed according to the composition ratio of the upper layer part described in Table 2 above, and stearyl alcohol and A wet granulation process was carried out with a combined solution composed of ethyl cellulose (Ethocel100cpSTD.PREM.). The granules are dried to make a granule dosage form. Here, polyethylene oxide, magnesium stearate, and hard anhydrous silicic acid were mixed to prepare an upper layer composition.

[0042] Next, alfuzosin hydrochloride, microcrystalline cellulose, and hydroxypropyl cellulose-H (HPC-H) were mixed according to the composition ratio of the lower colorless layer described in Table 2 above, stearyl alcohol was added, and wet granulation was performed. process. The granules are dried to make a granule dosage form. Here, polyethylene oxide, low-substituted...

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Abstract

The invention provides alfuzosin hydrochloride-containing slow-release tablets. The tablets are characterized in that: the tablets comprise an upper layer part and a lower layer part, wherein the upper layer part comprises, by weight, 0.2 parts alfuzosin hydrochloride, 90 parts of hydroxyl propyl methyl cellulose, 29.6 parts of polyethylene oxide, 1 part of stearyl alcohol, 0.4 parts of hard anhydrous silicic acid, 1 part of ethyl cellulose, and the lower layer part comprises, by weight, 9.8 parts of alfuzosin hydrochloride, 36-62 parts of microcrystalline cellulose, 24-60 parts of polyethylene oxide, 20 parts of low substitution degree hydroxypropyl cellulose, 1-6 parts of stearyl alcohol, and 99 parts of hydroxypropyl cellulose. According to the present invention, the upper layer part and the lower layer part of the alfuzosin hydrochloride-containing slow-release tablets contain the hydrophilic slow-release preparation and the liposoluble wax, such that the interlayer expansibility is similar, and the interlayer adhesion is excellent.

Description

technical field [0001] The present invention relates to a sustained-release tablet containing alfuzosin hydrochloride, in particular to a sustained-release tablet containing alfuzosin hydrochloride characterized by the following content, characterized in that: it contains the active substance alfuzosin hydrochloride Fuzosin hydrochloride, hydrophilic macromolecular substance polyethylene oxide, hydroxypropyl methylcellulose, and fat-soluble wax stearyl alcohol, and is composed of an upper layer containing 2 parts by weight of the active substance and containing A double-layer structure consisting of the lower layer of the active material in 98 parts by weight. Background technique [0002] Alfuzosin hydrochloride (AlfuzosineHCl) is a powerful blocker of alpha adrenergic receptors and is a widely used preparation for the treatment of benign prostatic enlargement. However, alfuzosin hydrochloride has a very short in vivo half-life and a strong absorption rate in the duodenum ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/24A61K31/517A61K47/38A61P13/08
Inventor 鱼津金昌焕韩昌均郑贤根金亮仲金钟杰朴正起
Owner AHN GOOK PHARMA CO LTD
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