Lamotrigine sustained release tablet and preparation method of lamotrigine sustained release tablet

A technology for lamotrigine and sustained-release tablets, applied in the field of lamotrigine sustained-release tablets and their preparation, can solve the problems of general prediction of deterioration, increase the risk of epileptic seizures, etc., achieve long maintenance time and reduce irritation and adverse reactions, the effect of reducing side effects

Inactive Publication Date: 2014-07-30
QINGDAO CENT HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, it is generally believed that each seizure may incr

Method used

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  • Lamotrigine sustained release tablet and preparation method of lamotrigine sustained release tablet
  • Lamotrigine sustained release tablet and preparation method of lamotrigine sustained release tablet
  • Lamotrigine sustained release tablet and preparation method of lamotrigine sustained release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] prescription:

[0043]

[0044] Preparation process

[0045] 1, prepare povidone ethanol solution Get the povidone K30 of recipe quantity and make 10% (w / w) ethanol solution, standby;

[0046] 2. Granulation: After sieving lamotrigine and mannitol with 80 meshes respectively, put them into a mixing granulator together with hypromellose and microcrystalline cellulose, mix them, and add povidone ethanol solution after uniformity. Wet granulation, take out the granules and use a 20-mesh sieve for wet granulation. After drying, pass through a 20-mesh sieve for granulation and set aside.

[0047] 3. Tablet compression. After mixing the prepared granules with the prescribed amount of magnesium stearate evenly, test the content to determine the tablet weight, and punch the tablet with φ16x7.

Embodiment 2

[0049] prescription:

[0050]

[0051] Preparation process

[0052] 1. Prepare cross-linked polyvinylpyrrolidone ethanol solution, take the prescribed amount of cross-linked polyvinylpyrrolidone to make 10% (w / w) ethanol solution, and set aside;

[0053] 2. Granulation: After sieving lamotrigine and lactose with 80 meshes respectively, put them into a mixing granulator together with hypromellose and microcrystalline cellulose, mix them, and add povidone ethanol solution for wet Granulation method, take out the granules and use a 20-mesh sieve for wet sizing. After drying, pass through a 20-mesh sieve for granulation and set aside.

[0054] 3. Tablet compression. After mixing the prepared granules with the prescribed amount of magnesium stearate evenly, test the content to determine the tablet weight, and punch the tablet with φ16x7.

Embodiment 3

[0056] prescription:

[0057]

[0058] Preparation process

[0059] 1, prepare povidone ethanol solution, get the povidone of recipe quantity and make 10% (W / W) ethanol solution, standby;

[0060] 2. Granulation: After sieving lamotrigine and mannitol with 80 meshes respectively, put them into a mixing granulator together with hypromellose and microcrystalline cellulose, mix them, and add povidone ethanol solution after uniformity. Wet granulation, take out the granules and use a 20-mesh sieve for wet granulation. After drying, pass through a 20-mesh sieve for granulation and set aside.

[0061] 3. Tablet compression. After mixing the prepared granules with the prescribed amount of magnesium stearate evenly, test the content to determine the tablet weight, and punch the tablet with φ16x7.

[0062] Biological activity test

[0063] In order to investigate the in vitro release effect of the present invention, according to the release assay method (Chinese Pharmacopoeia ve...

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PUM

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Abstract

The invention aims to provide a lamotrigine sustained release tablet, which is stable in drug release and higher in medication safety and is characterized by comprising lamotrigine with the effective therapeutic dose and physiologically acceptable pharmaceutical accessories. The lamotrigine sustained release tablet disclosed by the invention has the characteristics of being convenient for drug delivery, lasting in effect, stable in curative effect, low in toxic and side effect and the like.

Description

field of invention [0001] The invention relates to a pharmaceutical preparation for treating epilepsy and a preparation method thereof, which belongs to medicine for neurosurgery diseases, and in particular to a lamotrigine sustained-release tablet and a preparation method thereof. Background of the invention [0002] Lamotrigine, 3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine is disclosed in US4602017 and EP0021121. Lamotrigine-containing products are marketed by the GlaxoSmithKline group of companies under the trade name LAMICTAL TM . These products are particularly effective in the treatment of CNS disorders, especially epilepsy, pain, edema, multiple sclerosis and psychiatric indications including bipolar disorders. [0003] Various tablet formulations of lamotrigine have been approved for sale, for example, conventional compressed immediate release (IR) tablets containing 25 mg, 50 mg, 100 mg, 150 mg or 200 mg of active ingredient. These tablet formulations are ad...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/53A61P25/08A61P29/00A61P25/28A61P25/18
Inventor 赵明媚李敏陈瑶刚
Owner QINGDAO CENT HOSPITAL
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