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Modafinil dispersible tablet and preparation method thereof

A technology of dispersible tablets and weight ratio, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve the problems of dissolution and bioavailability that are difficult to achieve therapeutic effects. To achieve the effect of good short-term tolerance

Active Publication Date: 2014-12-10
XIANGBEI WELMAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its dissolution rate and bioavailability are difficult to achieve the desired therapeutic effect

Method used

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  • Modafinil dispersible tablet and preparation method thereof
  • Modafinil dispersible tablet and preparation method thereof
  • Modafinil dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] (Specification: 200mg / tablet)

[0033] formula:

[0034]

[0035] preparation:

[0036] (1) Pulverize modafinil through a 260 mesh sieve.

[0037] (2) Carboxymethyl starch sodium and microcrystalline cellulose are respectively passed through a 200-mesh sieve.

[0038] (3) The starch is passed through an 80-mesh sieve.

[0039] (4) Micropowder silica gel is passed through a 300-mesh sieve, and stearic acid is passed through a 200-mesh sieve.

[0040] (5) Modafinil, microcrystalline cellulose, starch and half of the formula amount of carboxymethyl starch sodium and starch are mixed uniformly according to the ratio of the recipe amount, and the soft material is made with 1% PVP aqueous solution, and the wet granules are made through a 20-mesh sieve. Ventilate and dry at 60°C (the moisture content of the dry particles is 2%), and granulate with a 20-mesh sieve;

[0041] (6) Micropowder silica gel, stearic acid and the remaining amount of sodium carboxymethyl starch ...

Embodiment 2

[0043] (Specification: 200mg / tablet)

[0044] formula:

[0045]

[0046]

[0047] preparation:

[0048] (1) Crushing the main ingredient through a 260-mesh sieve.

[0049] (2) Low-substituted hydroxypropyl cellulose and microcrystalline cellulose are respectively passed through a 200-mesh sieve.

[0050] (3) The starch is passed through an 80-mesh sieve.

[0051] (4) Micropowder silica gel is passed through a 300-mesh sieve, and stearic acid is passed through a 200-mesh sieve.

[0052] (5) Mix modafinil, microcrystalline cellulose, starch and half of the low-substituted hydroxypropyl cellulose and starch according to the proportion of the prescription, and use 1% PVP aqueous solution to make a soft material, and use a 20-mesh sieve to make a wet The granules are ventilated and dried at 60°C (the moisture content of the dry granules is 2%), and granulated with a 20-mesh sieve;

[0053] (6) Micropowder silica gel, stearic acid and the remaining amount of low-substitut...

Embodiment 3

[0055] (Specification: 200mg / tablet)

[0056] formula:

[0057]

[0058]

[0059] preparation:

[0060] (1) Crushing the main ingredient through a 260-mesh sieve.

[0061] (2) Carboxymethyl starch sodium, lactose, and mannitol were respectively passed through a 200-mesh sieve.

[0062] (3) Micropowder silica gel is passed through a 300-mesh sieve, and stearic acid is passed through a 200-mesh sieve.

[0063] (4) Mix modafinil, lactose, mannitol and sodium carboxymethyl starch with half of the formula quantity and starch according to the proportion of the prescription quantity, and use 1% sodium carboxymethylcellulose aqueous solution to make the soft material, and sieve it with 20 mesh Wet granules are ventilated and dried at 60°C (moisture content of dry granules is 2%), and granulated with a 20-mesh sieve;

[0064] (5) Micropowder silica gel, stearic acid and the remaining amount of sodium carboxymethyl starch are fully mixed, punched with a 9mm shallow arc, and pa...

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Abstract

The invention provides modafinil dispersible tablets, which comprise the following components: 100 to 300 g of modafinil, 50 to 200 g of diluent, 1 to 20 g of disintegrant, 0.1 to 10 g of glidant and 0.1 to 10 g of lubricant. Studies on the preparation process, packing materials, quality and stability of modafinil indicate that the process of the invention is stable and feasible and all quality indexes of the product conform to the requirements of the Chinese pharmacopoeia. The modafinil dispersible tablets subjected to accelerated tests and room-temperature sample reservation tests do not change obviously in terms of appearance, content, relevant substances and the like, indicating high stability. The randomized controlled clinical trials of the modafinil dispersible tablets treating excessive daytime somnolence caused by the obstructive sleep apnea hyponea syndrome show that: the modafinil dispersible tablets have effects of obviously shortening the daytime somnolence time, reducing the somnolence times and keeping vigility, the comprehensive curative effect is obviously better than that of a blank control group, and the adverse reaction incidence is low. The invention provides a preparation method.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a psychotropic drug modafinil dispersible tablet and a preparation method thereof. Background technique [0002] Modafinil (Modafinil) is a kind of psychostimulant drug developed by Lafon Company of France, which was listed in France for the first time in November 1994. Its chemical name is: 2-benzhydrylsulfinylacetamide [0003] Structural formula: [0004] [0005] Modafinil is different from traditional psychostimulants such as amphetamine and caffeine. It has good safety, good tolerance, no mental dependence, and no series of withdrawal symptoms after drug withdrawal. After taking this product, it can produce mental excitement, enhance the ability to move, and maintain the state of awakening without stereotyped sexual behavior. This product has almost no side effects, does not affect the normal functions of the human body (such as blood pressure, heart rate, etc.) substi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/165A61K47/38A61P25/26
Inventor 孙明杰王霆邓桂兴
Owner XIANGBEI WELMAN PHARMA CO LTD
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