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Orodispersible domperidone tablets

A technology of domperidone and dispersible tablets, which is applied in the direction of organic active ingredients, medical preparations containing active ingredients, drug combinations, etc., and can solve problems such as tablet breakage

Inactive Publication Date: 2013-05-29
PIERRE FABRE MEDICAMENT SAS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These tablets require the use of aluminum blister packs that effectively protect the tablets in storage, but removal of the tablets from the blister packs inevitably results in tablet rupture
In addition, other difficulties arose during the preparation of these tablets, especially in relation to the fluidity of powder mixtures, which can form more or less spherical granules

Method used

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  • Orodispersible domperidone tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Embodiment 1 (domperidone tablet)

[0073] step 1:

[0074] In a planetary or paddle mixer, put the following compounds:

[0075] — Mannitol 60

[0076] -Domperidone

[0077] — Maltodextrin

[0078] - croscarmellose sodium (50% of the total amount)

[0079] mix

[0080] Step 2:

[0081] In a container of sufficient capacity, add:

[0082] -pure water

[0083] Slowly pour purified water over the moving mixture.

[0084] Mix until a suitable granulation is obtained.

[0085] Step 3:

[0086] The wet mass obtained in step 2 was pulverized with a vibrating granulator equipped with an 8 mm screen.

[0087] The crushed particles were collected in a tared fluid bed tank.

[0088] Step 4:

[0089] Dry the wet granules in a fluidized bed until the residual moisture is less than or equal to 2%.

[0090] Step 5:

[0091] The following materials were size classified using a vibrating granulator fitted with a 1 mm screen:

[0092] — dry granules

[0093] — Peppermi...

Embodiment 2

[0116] Example 2: Tablets Containing Mequinazine

Embodiment 3

[0117] Example 3: Tablets containing codeine base

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Abstract

The present invention relates to an orodispersible tablet comprised of, by weight: a maximum of 15% of a low-dose, therapeutically active substance; from 55% to 70% of mannitol of a particle size between 30 μm and 300 μm; at least 2% of maltodextrin; from 3.5% to 8% of croscarmellose sodium; from 10% to 20% of microcrystalline cellulose; from 0.5% to 1.5% of magnesium stearate; and from 1% to 5% of flavoring (s) and sweetener (s).

Description

technical field [0001] The present invention relates to a new type of solid composition containing low doses of therapeutically active substances in the form of orodispersible tablets, which can be rapidly disintegrated in the oral cavity due to its low friability and appropriate hardness, and can be used in good industrial conditions. manufactured under conditions. Background technique [0002] Within the scope of this patent application, "low-dose, therapeutically active substance" means that the active substance is present in the tablet in an amount of up to 15%, preferably 0.5% to 12%, by weight compared to the total weight of the tablet. Among the active ingredients specifically pointed out in the present invention, domperidone, mequinazine, codeine base and loperamide hydrochloride can be used as illustrative examples. However, the invention is not limited to these specific active ingredients, but extends to all therapeutically active ingredients, usually administered...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/454A61K9/20
CPCA61K31/454A61K9/2077A61K9/2018A61K9/0056A61K9/2054A61P1/08A61K9/20
Inventor J-F·科多利亚尼D·贝图米厄
Owner PIERRE FABRE MEDICAMENT SAS
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