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Febuxostat-containing pharmaceutical composition and preparation technology for febuxostat tablets

A technology for febuxostat and a composition, which is applied in the field of pharmaceutical preparation, can solve problems such as low bioavailability, and achieve the effects of simple preparation process, high dissolution rate, and reduced production cost

Inactive Publication Date: 2016-12-07
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is a problem of low bioavailability of febuxostat at present

Method used

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  • Febuxostat-containing pharmaceutical composition and preparation technology for febuxostat tablets
  • Febuxostat-containing pharmaceutical composition and preparation technology for febuxostat tablets
  • Febuxostat-containing pharmaceutical composition and preparation technology for febuxostat tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Embodiment 1: febuxostat tablet (10,000 pieces)

[0016]

[0017]

[0018] Preparation method: The raw and auxiliary materials are crushed and sieved for later use; use an electronic scale to weigh the prescribed amount of purified water, pour it into a stainless steel bucket, then weigh the prescribed amount of 95% ethanol, slowly add it to the purified water, and use a stirring rod continuously during the addition process Stir and prepare a 50% ethanol solution. Then take the prescribed amount of PVPK30, add it to 50% ethanol solution, and stir vigorously at the same time to make it fully dispersed and dissolved to form a transparent and clear solution, which is sealed for later use. Weigh febuxostat, microcrystalline cellulose 101, lactose and sodium carboxymethyl starch according to the prescription amount, dry mix for 15 minutes, add the prepared binder, stir for 3 minutes and then granulate with an 18-mesh sieve. Dry the granules at 50°C-60°C, add silicon d...

Embodiment 2

[0019] Embodiment 2: febuxostat tablet (10,000 pieces)

[0020]

[0021] Preparation method: The raw and auxiliary materials are crushed and sieved for later use; use an electronic scale to weigh the prescribed amount of purified water, pour it into a stainless steel bucket, then weigh the prescribed amount of 95% ethanol, slowly add it to the purified water, and use a stirring rod continuously during the addition process Stir and prepare a 50% ethanol solution. Then take the prescribed amount of PVPK30, add it to 50% ethanol solution, and stir vigorously at the same time to make it fully dispersed and dissolved to form a transparent and clear solution, which is sealed for later use. Weigh febuxostat, microcrystalline cellulose 101, lactose and sodium carboxymethyl starch according to the prescription amount, dry mix for 15 minutes, add the prepared binder, stir for 3 minutes and then granulate with an 18-mesh sieve. Dry the granules at 50°C-60°C, add silicon dioxide and m...

Embodiment 3

[0022] Embodiment 3: febuxostat tablet (10,000 pieces)

[0023]

[0024] Preparation method: The raw and auxiliary materials are crushed and sieved for later use; use an electronic scale to weigh the prescribed amount of purified water, pour it into a stainless steel bucket, then weigh the prescribed amount of 95% ethanol, slowly add it to the purified water, and use a stirring rod continuously during the addition process Stir and prepare a 50% ethanol solution. Then take the prescribed amount of PVPK30, add it to 50% ethanol solution, and stir vigorously at the same time to make it fully dispersed and dissolved to form a transparent and clear solution, which is sealed for later use. Weigh febuxostat, microcrystalline cellulose 101, lactose and sodium carboxymethyl starch according to the prescription amount, dry mix for 15 minutes, add the prepared binder, stir for 3 minutes and then granulate with an 18-mesh sieve. Dry the granules at 50°C-60°C, add silicon dioxide and m...

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Abstract

The invention belongs to the technical field of drug preparation and particularly relates to febuxostat-containing pharmaceutical composition and a preparation technology for febuxostat tablets. The febuxostat-containing pharmaceutical composition is prepared from raw material febuxostat and pharmaceutical adjuvants including microcrystalline cellulose, lactose, sodium carboxymethyl starch, PVPK30, magnesium stearate and silicon dioxide, specifically, the febuxostat-containing pharmaceutical composition is prepared from 25-40 parts by mass of febuxostat, 30-60 parts by mass of microcrystalline cellulose and lactose, 1.5-8 parts by mass of sodium carboxymethyl starch, 1-3 parts by mass of PVPK30 and 0.5-2 parts by mass of magnesium stearate and silicon dioxide. Compared with the prior art, the febuxostat tablets are good in stability and high in dissolution rate; the preparation technology is relatively simple, saves labor hours, reduces production cost and is suitable for enterprises'mass production.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a febuxostat pharmaceutical composition and a tablet preparation process thereof. Background technique [0002] Febuxostat is a new type of non-purine xanthine oxidoreductase (XOR) inhibitor for the treatment of gout patients with chronic hyperuricemia. It was first applied for marketing in Japan, the United States and Europe by Teijin Corporation of Japan in early 2004. On May 5, 2008, IPSEN's febuxostat tablet (trade name: ADENURIC) was approved by the European Union to go on the market in France; in February 2009, Takeda Pharmaceuticals America's (Takeda Pharmaceuticals America) Name: ULORIC) has also been approved by the US FDA. [0003] Febuxostat is highly selective for XOR, and has significant inhibitory effect on both oxidized and reduced XOR, and its Ki and Ki' values ​​for inhibiting XOR are 0.6 and 3.1 nM, respectively. At concentrations up t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/426A61K47/38A61K47/14A61K9/20A61P19/06
CPCA61K31/426A61K9/2059A61K9/2095A61K9/28A61K47/14A61K47/38
Inventor 吴荣翠卢秀莲杜振新
Owner CISEN PHARMA
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