Febuxostat osmotic pump controlled release tablet for treating gout and preparation method

A technology of osmotic pump controlled release and febuxostat, which is applied in the field of pharmaceutical preparations to achieve the effect of easy and safe production and preparation

Inactive Publication Date: 2012-08-22
SOUTHERN MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Although there have been some research reports on microporous osmotic pump tablets for other drugs, different drugs require different osmotic pressure active substances, porogens, plasticizers and other excipients and dosages due to their different physical and chemical properties. There are still many technical problems that need to be overcome and solved in the preparation of Sutent microporous osmotic pump controlled-release tablets. Only by adopting specific technical solutions can the sustained release of febuxostat be achieved at a zero-order speed

Method used

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  • Febuxostat osmotic pump controlled release tablet for treating gout and preparation method
  • Febuxostat osmotic pump controlled release tablet for treating gout and preparation method
  • Febuxostat osmotic pump controlled release tablet for treating gout and preparation method

Examples

Experimental program
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Effect test

Embodiment 1

[0044] prescription:

[0045]

[0046]

[0047] Preparation method: take 80 mesh febuxostat, lactose, sodium chloride, sodium carbonate and microcrystalline cellulose and mix evenly, add hypromellose aqueous solution with a concentration of 4%, mix evenly with a mixer to make a soft material, Granulate with a 16-mesh sieve, dry at 60°C, granulate with a 14-mesh sieve, add magnesium stearate and micronized silica gel, mix well, and press into tablets. Take cellulose acetate, polyethylene glycol 400 and diethyl phthalate, and use 500ml of acetone as a solvent to prepare a coating solution. Place the above-mentioned tablet cores in a coating pan for coating, the weight gain of the coating is 5% of the weight of the tablet cores, and after coating, put them in an oven at 40°C for 12 hours to age, and each tablet contains 50 mg of febuxostat. Take 1-2 tablets orally daily. The release rate of the febuxostat osmotic pump controlled-release tablet for the treatment of gout is...

Embodiment 2

[0049] prescription:

[0050] Tablet prescription:

[0051]

[0052] Coating prescription (the weight gain of the coating is 7% of the core weight):

[0053]

[0054]

[0055] Preparation method: take 80 mesh febuxostat, mannitol, sodium chloride, sodium hydroxide and mix with precrossed starch, add starch slurry with a concentration of 5%, mix evenly with a mixer to make soft material, 18 mesh Sieve and granulate, dry at 60°C, sieve with a 16-mesh sieve, add magnesium stearate, mix well, and press into tablets. Take cellulose acetate, polyethylene glycol 400 and diethyl phthalate, and use 500ml of acetone as a solvent to prepare a coating solution. Place the above-mentioned tablet cores in a coating pan for coating, the weight gain of the coating is 7% of the weight of the tablet cores, and after coating, put them in an oven at 40°C for aging for 12 hours, and each tablet contains 25 mg of febuxostat. Take 2-4 tablets orally every day. Adopt above-mentioned metho...

Embodiment 3

[0057] prescription:

[0058] Tablet prescription:

[0059]

[0060] Coating prescription (the weight gain of the coating is 5% of the weight of the tablet core):

[0061]

[0062] Preparation method: take 80 mesh febuxostat, glucose, sodium chloride, sodium carbonate and dextrin, mix evenly, add 5% povidone aqueous solution, mix by hand to make soft material, and granulate with 16 mesh sieve , dried at 60°C, granulated with a 14-mesh sieve, added with magnesium stearate and talcum powder, mixed evenly, and compressed into tablets. Take cellulose acetate, polyethylene glycol 400 and diethyl phthalate, and use 500ml of acetone as a solvent to prepare a coating solution. Place the above-mentioned tablet cores in a coating pan for coating, the weight gain of the coating is 5% of the weight of the tablet cores, and after coating, put them in an oven at 40°C for 12 hours to age, and each tablet contains 50 mg of febuxostat. Take 1-2 tablets orally daily. Adopt above-menti...

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Abstract

The invention relates to a medical preparation containing a Febuxostat compound and with special physical shape as a characteristic, in particular to a Febuxostat osmotic pump controlled release tablet for treating gout. The osmotic pump controlled release agent comprises a core tablet and a coat and is characterized in that the core tablet is composed of the following components by weight: 10% to 40% of Febuxostat, 30% to 60% of osmotic pressure active substance, 4% to 20% of alkaline substance, 0% to 30% of filler, 1% to 5% of adhesive and 0.2% to 2% of lubricant. The coat is composed of the following components by weight: 40% to 70% of cellulose acetate, 20% to 40% of polyethylene glycol 400 and 10% to 20% of phthalic acid diethyl ester. The tablet resolves the problem that the Febuxostat is slightly soluble medicine and is hard to release by adding the alkaline substance into the core tablet, is capable of releasing over 90% of medicine within 12 hours by screening optimization of film formation materials, porogen and plasticizers in the coat, and satisfies zero level dynamic medicine releasing characteristics. The Febuxostat osmotic pump controlled release tablet for treating gout can be used for treating gout and has the advantages of being durable in effect, safe and easy to produce and prepare.

Description

technical field [0001] The invention relates to a pharmaceutical preparation containing a febuxostat compound characterized by a special physical shape, in particular to a febuxostat osmotic pump controlled release tablet for treating gout. Background technique [0002] Gout is a joint disease caused by increased blood uric acid due to purine metabolism disorder. Deposition of urate crystals in the joint tissue will produce tophi, which will cause irreversible damage to the joint, resulting in joint deformity or dysfunction. The biggest hazard of gout is that it may cause kidney damage, and severe cases will die of kidney failure. The incidence of gout was low in the past, and it was called the "disease of the rich". However, in recent years, with the change of lifestyle and diet, the incidence of gout in my country has risen linearly, and the incidence of gout is now almost the same as that of diabetes. According to statistics, the incidence of gout among adult males in m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/22A61K31/426A61K47/38A61K47/02A61P19/06
Inventor 蔡铮刘中秋龚耘张嘉杰万山河罗辉黄娟雷晓璐
Owner SOUTHERN MEDICAL UNIVERSITY
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