Perampanel orally disintegrating tablets and preparation method thereof

A technology for orally disintegrating tablets and prescriptions, applied in the field of orally disintegrating tablets containing perampanel and its preparation, can solve the problems that patients cannot be effectively controlled, achieve good promotion prospects, simple and easy preparation process, and refreshing taste Effect

Inactive Publication Date: 2017-06-20
佛山市弘泰药物研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Perampanel is a popular antiepileptic drug because many patients with partial seizures cannot be effectively controlled by other treatments

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Ingredient Name Weight Percentage (%) Perampanel 1% Mannitol 50% Lactose 32% Sodium Carboxymethyl Starch 10% Povidone 3% Aspartame 2% Micronized Silica Gel 1% Magnesium Stearate 1%

[0027] Preparation:

[0028] (1) Micronize perampanel, grind the rest of the excipients separately and pass through a 100-mesh sieve;

[0029] (2) After sieving and mixing perampanel, mannitol, lactose, sodium carboxymethyl starch with a prescribed amount of 5%, and aspartame, add an aqueous solution of povidone ethanol with a concentration of 20% of the prescribed amount to prepare soft material;

[0030] (3) Granulate through a 20-mesh sieve, dry in an oven at 50°C until the moisture content of the granules is between 1.5 and 3.5%, and pass through a 24-mesh sieve for granulation;

[0031] (4) Add micropowder silica gel, magnesium stearate, and the remaining amount of sodium carboxymethyl starch to the dry granules obtained in (3), and mix well;

[0032] (5) Determining the content of ...

Embodiment 2

[0034] Ingredient Name Weight Percentage (%) Perampanel 2% Mannitol 45% Lactose 35% Croscarmellose Sodium 10% Hydroxypropyl Cellulose 2% Aspartame 2% Magnesium Stearate 1%

[0035] Preparation:

[0036] (1) Micronize perampanel, grind the rest of the excipients separately and pass through a 100-mesh sieve;

[0037] (2) After sieving and mixing perampanel, mannitol, lactose, 5% croscarmellose sodium and aspartame in the prescribed amount, add hydroxypropyl cellulose with a prescribed amount of 25% Vegetarian ethanol aqueous solution to prepare soft materials;

[0038] (3) Granulate through a 20-mesh sieve, dry in an oven at 50°C until the moisture content of the granules is between 1.5 and 3.5%, and pass through a 24-mesh sieve for granulation;

[0039] (4) Add magnesium stearate and the remaining amount of croscarmellose sodium to the dry granules obtained in (3), and mix well;

[0040] (5) Determining the content of intermediates, determining the weight of the tablet and p...

Embodiment 3

[0042] Ingredient Name Weight Percentage (%) Perampanel 4% Mannitol 50% Xylitol 31% Crospovidone 6% Hydroxypropyl Cellulose 4% Aspartame 2% Lemon Flavor 1% Micronized Silica Gel 1% Magnesium Stearate 1%

[0043] Preparation:

[0044] (1) Micronize perampanel, grind the rest of the excipients separately and pass through a 100-mesh sieve;

[0045] (2) After sieving and mixing perampanel, mannitol, xylitol, 3% crospovidone, aspartame, and lemon essence, add 20% prescription hydroxypropyl Cellulose-based ethanol aqueous solution to prepare soft materials;

[0046] (3) Granulate through a 20-mesh sieve, dry in an oven at 50°C until the moisture content of the granules is between 1.5 and 3.5%, and pass through a 24-mesh sieve for granulation;

[0047] (4) Add micropowder silica gel, magnesium stearate, and the remaining amount of crospovidone to the dry granules obtained in (3), and mix well;

[0048] (5) Determining the content of intermediates, determining the weight of the ta...

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Abstract

The invention discloses perampanel orally disintegrating tablets and a preparation method thereof. The orally disintegrating tablet is a pharmaceutical composition prepared from perampanel, a filling agent, a disintegrating agent, a wetting agent, an adhesive, a flavoring agent and a lubricant; the preparation method adopts a wet-process granulation and tabletting method. The invention aims at providing the perampanel orally disintegrating tablets which have the advantages of simple preparation process, low cost, convenience for oral administration, rapid effect and high bioavailability; the preparation can improve the oral administration compliance of patients and is good for treatment of diseases.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an orally disintegrating tablet containing perampanel and a preparation method thereof. Background technique [0002] Perampanel is an alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor antagonist that reduces neuronal overexcited. On October 22, 2012, it was approved by the FDA for marketing. This is the first antiepileptic drug with this mechanism of action approved by the FDA. Perampanel is a popular antiepileptic drug because many patients with partial seizures cannot be effectively controlled by other treatments. Current first-line antiepileptic drugs act by inhibiting postsynaptic glutamate AMPA receptors, which are now thought to be involved in seizures. Results of 3 clinical trials showed that patients taking perampanel had better seizure control than those taking placebo. This is the first FDA-approved antiepileptic drug with this mechan...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/444A61P25/08
CPCA61K9/2059A61K9/0056A61K9/2054A61K31/444
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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