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Tenofovir disoproxil fumarate tablets

A technology of tenofovir fumarate and disoproxil, applied in the field of pharmaceutical preparations, can solve the problems of low resistance of HIV-infected patients, very sensitive to external stimuli, unstable tablet quality, etc., to ensure product stability , the effect of improving disintegration time, good compressibility and capillary properties

Inactive Publication Date: 2015-05-27
LEPU PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Tenofovir disoproxil fumarate has good water solubility and can be quickly dissolved and absorbed by the gastrointestinal tract after being made into tablets orally. However, the chemical structure of TDF Containing multiple ester bonds, it is unstable and easily hydrolyzed when exposed to moisture, so the quality of the tablet is unstable
[0004] CN102198110A patent document discloses tenofovir disoproxil fumarate dispersible tablet and its preparation method, in order to solve the taking problem of patients with dysphagia and achieve faster The purpose of dissolution, but sodium lauryl sulfate is used in the prescription of the preparation, sodium lauryl sulfate has irritating effects on the eyes, skin, respiratory system, and mucous membranes, and the service objects of this drug are HIV-infected patients, HIV-infected patients Low resistance, very sensitive to external stimuli

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016]

[0017] Filling agent is lactose 110g, mannitol 100g and microcrystalline cellulose 94g.

[0018] The weight ratio composition of the coating agent is: lactose monohydrate 40%, hypromellose 29%, titanium dioxide 22.9% and glycerol acetate 8.1%.

Embodiment 2

[0020]

[0021] The filler is 120g of lactose, 80g of mannitol and 100g of microcrystalline cellulose.

[0022] The weight ratio of the coating agent is composed of: 35% lactose monohydrate, 30% hypromellose, 25% titanium dioxide and 10% glycerol acetate.

Embodiment 3

[0024]

[0025] The fillers are lactose 90g, mannitol 120g and microcrystalline cellulose 140g.

[0026] The weight ratio composition of the coating agent is: 45% of lactose monohydrate, 25% of hypromellose, 20% of titanium dioxide and 10% of glycerol acetate.

[0027] Examples 1-3 The following methods are adopted during the preparation of tenofovir disoproxil fumarate tablets:

[0028] 1) Weigh each raw material according to the prescription amount for later use;

[0029] 2) Particle manufacturing Mix tenofovir disoproxil fumarate, lactose, mannitol, 40-80% by weight of microcrystalline cellulose, binder, and 30-60% by weight of disintegrant in a CH-150 tank Mix evenly in the machine, then add purified water to make soft material, granulate with a sieve, dry and sieve for granulation;

[0030] 3) Total blending and tableting Add the remaining microcrystalline cellulose, remaining disintegrant and lubricant to the sized dry granules, mix them evenly in a SYH-200 t...

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Abstract

The invention belongs to the technical field of medicinal preparations, and specifically relates to tenofovir disoproxil fumarate tablets. The tablets comprise tenofovir disoproxil fumarate, a filler, an adhesive, a disintegrating agent, a lubricant and a coating agent; each tablet is 600-800mg and contains 300mg of tenofovir disoproxil fumarate, 25-65% of the filler, 2-5% of the adhesive, 3-15% of the disintegrating agent, 1-3% of the lubricant and 2-3% of the coating agent. The tenofovir disoproxil fumarate tablets have the advantages of low cost and stable product quality.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a tenofovir disoproxil fumarate tablet. Background technique [0002] Tenofovir disoproxil fumarate (TDF) is an ester prodrug of tenofovir, which belongs to a new type of nucleotide reverse transcriptase inhibitor, which can inhibit the replication of HIV and HBV viruses. Its main mechanism of action is that it is hydrolyzed to tenofovir after oral administration, and tenofovir is phosphorylated by cellular kinases to generate a pharmacologically active metabolite, tenofovir diphosphate. In 2001 and 2002, tenofovir disoproxil fumarate tablets were approved by the US FDA and the European Union for the treatment of AIDS; in 2008, the European Union and FDA approved it for the treatment of hepatitis B. At present, tenofovir disoproxil fumarate has been marketed in China for the treatment of AIDS, but it has not been approved for the treatment of hepa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/675A61K47/38A61K47/32A61K47/26A61K47/10A61P31/18A61P31/20
Inventor 王庆鹏熊长红孙冬梅
Owner LEPU PHARMACEUTICAL CO LTD
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