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TDF (tenofovir disoproxil fumarate) pellets and preparation method thereof

A technology for tenofovir fumarate and pyrifurate pellets, which is applied in the field of medicine, can solve problems such as restricting normal taking of medicines, and achieve the effects of avoiding burst release effect, less irritation, and low production cost.

Inactive Publication Date: 2015-12-16
SUZHOU HOMESUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, for special patients such as dysphagia, children, and the elderly, peripheral factors restrict their ability to take medicine normally

Method used

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  • TDF (tenofovir disoproxil fumarate) pellets and preparation method thereof
  • TDF (tenofovir disoproxil fumarate) pellets and preparation method thereof
  • TDF (tenofovir disoproxil fumarate) pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] This embodiment provides a kind of tenofovir disoproxil fumarate pellets. The tenofovir disoproxil fumarate pellets are prepared by the following steps:

[0033] Take tenofovir disoproxil fumarate 60g, κ-carrageenan 28.0g, lactose 10.0g, crospovidone 0.8g, pass through a 60-mesh sieve and mix evenly, add ethanol 1.2g as a wetting Adhesives are made of soft materials, and then added to an extrusion spheronizer with a screen aperture of 0.6mm to obtain tenofovir disoproxil fumarate drug-containing pellets, dried until the weight loss on drying is less than 3.0%, and then added to the gastric solution Type coating liquid is used for coating, and the weight gain of the coating is controlled not to exceed 3%.

[0034] Get the above-mentioned tenofovir disoproxil fumarate pellets 80g, microcrystalline cellulose 18.0g, croscarmellose sodium 1.4g and magnesium stearate 0.6g, mix uniformly, press into tablets, and obtain .

Embodiment 2

[0036] This embodiment provides a kind of tenofovir disoproxil fumarate pellets. The tenofovir disoproxil fumarate pellets are prepared by the following steps:

[0037] Take 60g of tenofovir disoproxil fumarate, 32g of microcrystalline cellulose, 6.0g of lactose, and 0.7g of croscarmellose sodium, pass through a 60-mesh sieve and mix well, add 1.3g of water as a wetting Adhesives are made of soft materials, and then added to an extrusion spheronizer with a screen aperture of 0.6mm to obtain tenofovir disoproxil fumarate drug-containing pellets, dried until the weight loss on drying is less than 3.0%, and then added to the gastric solution Type coating liquid is used for coating, and the weight gain of the coating is controlled not to exceed 3%.

[0038] Get above-mentioned tenofovir disoproxil fumarate pellets 82g, pregelatinized starch 17.0g, croscarmellose sodium 0.6g and hard sodium fumarate 0.4g mix uniformly, press into tablet, Instantly.

Embodiment 3

[0040] This embodiment provides a kind of tenofovir disoproxil fumarate pellets. The tenofovir disoproxil fumarate pellets are prepared by the following steps:

[0041]Take 56g of tenofovir disoproxil fumarate, 18g of microcrystalline cellulose, 19.0g of κ-carrageenan, 4.0g of pregelatinized starch, and 1.2g of low-substituted hydroxypropyl cellulose, and pass through a 60-mesh sieve After mixing evenly, add ethanol 1.8g as the soft material of wetting adhesive system, then add the sieve aperture and be the extruding spheronizer of 0.6mm to obtain tenofovir disoproxil fumarate drug-containing pellets, dry to The weight loss on drying is less than 3.0%, and then the gastric soluble coating solution is added for coating, and the weight gain of the coating is controlled to be no more than 3%.

[0042] Get above-mentioned tenofovir disoproxil fumarate pellets 83g, microcrystalline cellulose 9.0g, pregelatinized starch 6.0g, croscarmellose sodium 1.4g and micropowder silica gel 0....

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Abstract

The invention belongs to the field of medicines and discloses TDF (tenofovir disoproxil fumarate) pellets and a preparation method thereof. The TDF pellets are prepared from raw materials comprising 70-90 parts of TDF pellets by weight and 6-32 parts of a pharmaceutic adjuvant by weight through pressing, wherein the TDF pellets are prepared from raw materials comprising components in parts by weight as follows: 20-80 parts of TDF, 10-75 parts of filler, 0.5-2 parts of a disintegrating agent and 1-5 parts of a moistening adhesive. Compared with tablets in the traditional process, the prepared TDF pellets are convenient to take, good in stability, high in dissolution rate, quick and uniform to release and small in irritation to gastrointestinal tracts, significantly improve the bioavailability of medicines and have great clinical significance.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to tenofovir disoproxil fumarate pellets and a preparation method thereof. Background technique [0002] Tenofovir disoproxil fumarate, namely Tenofovir Disoproxil Fumarate, TDF, trade name Viread (Chinese translation "Viread"), is a nucleotide reverse transcriptase inhibitor (NRTIs) produced by GileadSciences in the United States. The activity of HIV-1 reverse transcriptase inhibits the replication of HIV and HBV viruses. Tenofovir disoproxil fumarate is an acyclic nucleoside phosphodiester analogue of adenosine monophosphate. Tenofovir disoproxil fumarate is first converted to tenofovir by ester hydrolysis and then phosphorylated by cellular enzymes to form tenofovir diphosphate, an obligate chain terminator. Tenofovir diphosphate inhibits the activity of HIV-1 reverse transcriptase and HBV reverse transcriptase by competing with the natural substrate deoxyadenosine 5'-triphosp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/16A61K31/675A61P31/18A61P31/20
Inventor 陆红彬杨磊
Owner SUZHOU HOMESUN PHARMA
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