Adefovir dipivoxil oral disintegration tablets preparation method

A technology of adefovir dipivoxil and oral disintegrating tablets, applied in the directions of pill delivery, digestive system, antiviral agent, etc., can solve problems such as restriction and poor compliance, achieve good promotion prospects, simple and convenient preparation process, and no need to repeat effect of investment

Inactive Publication Date: 2010-05-05
CHONGQING SHENGHUAXI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, at present, this drug has poor compliance for some patients such as the elderly, children and patients with dysphagia, and its use under special conditions such as going out or lack of drinking water will also be greatly restricted

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Drug composition: Adefovir dipivoxil 10g

[0024] Microcrystalline Cellulose 100g

[0025] Polyethylene Glycol-6000 8g

[0026] Sodium Lauryl Sulfate 2g

[0027] Stevioside 0.75g

[0028] Menthol 0.75g

[0029] Low-substituted hydroxypropyl cellulose (L-HPC) 6g

[0030] Instant Sorbitol 8g

[0031] Strawberry essence 0.5g

[0032] Talc powder 1g

[0033] Magnesium stearate 0.3g

[0034] Made into: 1000 pieces

[0035] Preparation method: use conventional tablet equipment to prepare by wet granulation process: blend instant sorbitol, microcrystalline cellulose and adefovir dipivoxil, grind and pass through a 100-mesh sieve, and mix polyethylene glycol, lauryl Sodium sulfate, stevioside, and menthol are made into 30ml aqueous solution, and the above-mentioned mixed fine powder is added to make a soft material, which is vacuum-dried below 60°C, and the water content is controlled at 2.5%. Sieve the fine powder and add appropriate amount of strawberry essence, the...

Embodiment 2

[0038] Drug composition: Adefovir dipivoxil 10g

[0039] Polyvinylpyrrolidone 4g

[0040] Stevioside 1g

[0041] Menthol 0.75g

[0042] Strawberry essence 0.5g

[0043] Microcrystalline Cellulose 110g

[0044] Sodium carboxymethyl starch 6g

[0045] Mannitol 20g

[0046] Micronized silica gel 5g

[0047] Magnesium stearate 0.75g

[0048] Made into: 1000 pieces

[0049]Preparation method: In the conventional tablet pharmaceutical equipment, the direct tableting process has been prepared: after dissolving adefovir dipivoxil, stevioside, menthol, and strawberry essence with ethanol or supplemented with ultrasonic treatment to promote dissolution, use mannitol, micro Absorbed by crystalline cellulose, mix well, evaporate ethanol completely under the conditions of vacuum degree -0.096Mpa and ≤50℃, and dry. Pass the sodium carboxymethyl starch through an 80-mesh sieve, and dry it at a suitable temperature, keep the water content below 1%, add it together with magnesium stea...

Embodiment 3

[0052] Drug composition: Adefovir dipivoxil 10g

[0053] Microcrystalline Cellulose 80g

[0054] Lactose 35g

[0055] Low-substituted hydroxypropyl cellulose 6g

[0056] Polyvinylpyrrolidone 4g

[0057] Stevioside 0.75g

[0058] Menthol 0.75g

[0059] Strawberry essence 0.5g

[0060] Sorbitol 5g

[0061] Micronized silica gel 5g

[0062] Magnesium stearate 0.75g

[0063] Made into: 1000 pieces

[0064] Preparation method: Prepared by wet tableting process in conventional tablet pharmaceutical equipment: mix lactose, microcrystalline cellulose and adefovir dipivoxil and grind finely through a 100-mesh sieve. Polyvinylpyrrolidone, stevioside, menthol, and strawberry essence are made into 30ml aqueous solution, and the above-mentioned mixed fine powder is added to make wet granules, which are vacuum-dried below 60°C, and the moisture content is not more than 2.5%, and then add the prescribed amount at an appropriate temperature Pre-dried low-substituted hydroxypropyl ce...

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PUM

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Abstract

An oral disintegrating tablet of adefovirdipivoxil ester contains adefovirdipivoxil ester, dispersing solid carrier, filler, disintegrant, flavouring, lubricant and flow aid through wet granulating and tabletting,or direct tabletting. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to an orally disintegrating tablet pharmaceutical preparation of adefovir dipivoxil and a preparation method thereof. Background technique [0002] Adefovir dipivoxil (adefovir dipivoxil) is a purine derivative, which is a new type of open-chain nucleotide. Adefovir dipivoxil can inhibit the activity of DNA polymerase of HBV and can penetrate into the DNA of hepatitis B virus. Inhibiting the replication of the virus has a strong inhibitory effect on HBV virus strains resistant to lamivudine and famciclovir. This drug has been reported and used now, but it only involves the drug in its common tablet form. Because common tablet medicine generally all needs to help swallowing by drinking water when taking, and can reduce the damage to people's digestive tract. Therefore, at present, this drug has poor compliance for some patients such as the elderly, children and patients with dysphagia, and its use under special conditions such as ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/675A61K9/20A61P31/20A61P1/16
Inventor 钟声荣江桂清
Owner CHONGQING SHENGHUAXI PHARMA CO LTD
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