Multilayer orodispersible tablet

A tablet and mouth-dissolving technology, applied in the field of multi-layer mouth-dissolving tablets and their preparation, can solve problems such as inability to use or be used for mouth-dissolving tablets and the like

Inactive Publication Date: 2006-07-26
ETHYPHARM SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0029] Due to the limitations of the above-mentioned known schemes for designing combinations of active substances, they cannot be used in mouth-dissolving tablets, and when it is necessary to mask the taste of the active substances, the above-mentioned scheme cannot be used.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0180] A bilayer, melt-in-the-mouth tablet containing 500 mg of paracetamol (acetaminophen) and 65 mg of caffeine was prepared.

[0181] 1 / mixture

[0182] The first layer of powder mix (Layer A) was prepared according to the recipe in Table 1.

[0183] Composition (% mass / mass)

Coated paracetamol

46.9％

Mannitol M300

21.5％

Mannitol 60

21.5％

Polyvinylpyrrolidone CL

6.9％

Sucralose

1.0％

Mint Root Beer Flavoring

1.0％

Vanilla Cookie Flavor

0.2％

Magnesium stearate

1.0％

total

100％

[0184] Coated paracetamol granules are prepared by granulation and coating in a fluidized bed.

[0185] The particle size distribution of the particles is measured by laser diffraction: the size of the coated particles accounting for 98% of the total mass is between 150 microns and 500 microns.

[0186] The various components were stirred at a speed of 10 rpm for 15 min...

Embodiment 2

[0206] A bilayer melt-in-mouth tablet containing 325 mg of paracetamol and 37.5 mg of tramadol hydrochloride (tramadol HCL) was prepared.

[0207] A batch of 14,000 bilayer tablets was prepared in the following manner.

[0208] 1 / mixture

[0209] All mixtures were prepared as in Example 1.

[0210] The first layer of mixture (A layer, quality 800 mg) at first includes coated with 20% (coating polymer dry weight to coating particle weight) polymer mixture (Eudragit  E100 / Eudragit  The ratio of NE30D is 67 / 33) paracetamol in the coating layer, and also includes tablet excipients, and the ratio is shown in Table 5.

[0211] Composition (% mass / mass)

Coated paracetamol

46.0％

Mannitol M300

20.6％

Mannitol 60

20.6％

Polyvinylpyrrolidone CL

9.4％

Aspartame

1.9％

Mint Root Beer Flavoring

0.9％

Magnesium stearate

0.6％

total

100％

[0212] The second layer of mixtur...

Embodiment 3

[0228] Two-layer, orally dissolving tablets containing 200 mg of ibuprofen and 37.5 mg of tramadol hydrochloride (tramadol HCL) were prepared.

[0229] A batch of 14,000 bilayer tablets was prepared in the following manner.

[0230] 1 / mixture

[0231] All mixtures were prepared as in Example 1.

[0232] Coated ibuprofen granules are prepared in a fluidized bed by granulation and coating.

[0233] The particle size distribution is measured by laser diffraction: D 50％ 258 microns, 2% of the total mass of coated particles is less than 90 microns, and 1% of the total mass of coated particles is greater than 500 microns.

[0234] The first layer mixture (layer A) at first includes the ibuprofen of the coating layer of ethylcellulose N7 coated with 13.7% (dry weight of the coating polymer to the weight of the coating granules), and also includes tableting excipients, the ratio See Table 9.

[0235] Composition (% mass / mass)

coated ibuprofen

32.0

M...

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PUM

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Abstract

The invention relates to an orally-dispersible multilayer tablet and the method for production thereof.

Description

technical field [0001] The invention relates to a multi-layer mouth-dissolving tablet and a preparation method thereof. Background technique [0002] Term: "Mouth-dissolving tablet" means a tablet that disintegrates or dissolves within 60 seconds (preferably less than 40 seconds) upon contact with saliva in the mouth without chewing, forming a fine particle suspension that is easy to swallow liquid. [0003] Disintegration time is the time elapsed from the moment the tablet is placed on the tongue to the end of swallowing the disintegration of the tablet or the suspension resulting from dissolution. [0004] Such tablets are described in EP 548 356, EP 636 364, EP 1 003 484, EP 1 058 538, WO 98 / 46215, WO 00 / 06126, WO 00 / 27357 and WO 00 / 51568. [0005] After swallowing, the microparticles of the active substance release the active substance into the lower regions of the gastrointestinal tract. [0006] Due to its ease of use, the melt-in-the-mouth tablet is perfectly suita...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/00A61K9/24
CPCA61K9/006A61K9/209
Inventor 帕斯卡尔·乌里格尔·拉穆勒卡特琳·埃里扬·普雷沃斯特
Owner ETHYPHARM SA
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