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Alfuzosin hydrochloride-containing slow-release tablets

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

Active Publication Date: 2012-05-30
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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  • Alfuzosin hydrochloride-containing slow-release tablets
  • Alfuzosin hydrochloride-containing slow-release tablets
  • Alfuzosin hydrochloride-containing slow-release tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～5

[0030] Alfuzosin hydrochloride, hydroxypropyl methylcellulose 2208 (HPMC 2208, Methocel K100M CR Premium), hydrogenated castor oil (Lubri-wax) and iron oxide were mixed according to the composition ratio of the upper layer part recorded in the following table 1, and added by Stearyl alcohol and ethyl cellulose (Ethocel 100cp STD.PREM.) combined solution, and implement the 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 cellul...

Embodiment 6～10

[0038]

[0039]

[0040]

[0041]Alfuzosin hydrochloride, hydroxypropyl methylcellulose 2208 (HPMC 2208, Methocel K100M CR Premium), hydrogenated castor oil (Lubri-wax) and iron oxide were mixed according to the composition ratio of the upper layer described in Table 2 above, and added A wet granulation process was carried out with a combined solution consisting of stearyl alcohol and ethyl cellulose (Ethocel 100cp STD.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-sub...

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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 (Alfuzosine HCl), a potent blocker of alpha adrenergic receptors, 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 and je...

Claims

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Application Information

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Patent Type & Authority Applications(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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