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Perampanel dispersible tablet and preparation method thereof

A technology for perampanel and dispersible tablets, applied in the field of perampanel dispersible tablets and its preparation, can solve the problems of reducing drug bioavailability, affecting drug disintegration and dissolution, etc., to prolong storage period and improve stability , Guarantee the effect of quality

Inactive Publication Date: 2016-02-03
万全万特制药(厦门)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, perampanel only has ordinary film-coated tablets on the market abroad, and there are still no varieties of preparations on the market in China, and there are only ordinary tablets in the application category. Because the raw material of perampanel is basically insoluble in water, it is an insoluble drug, so , making ordinary tablets affects the disintegration and dissolution of the drug, reducing the bioavailability of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1: Perampanel dispersible tablet, the composition is as follows:

[0032] Perampanel 10g

[0033] Mannitol 43g

[0034] Microcrystalline Cellulose PH10 120g

[0035] Low-substituted hydroxypropyl cellulose 20g

[0036] Magnesium stearate 1g

[0037] Povidone 3g

[0038] Acesulfame K 3g

[0039] Made in 1000 pieces.

[0040] The preparation method is as follows:

[0041] 1) Micronize perampanel, and its particle size distribution D90 is less than 10 μm; the auxiliary materials are passed through a 100-mesh sieve, and set aside;

[0042] 2) Weigh mannitol, microcrystalline cellulose PH101, internally added low-substituted hydroxypropyl cellulose according to the prescription amount, add the prescription amount of perampanel, and mix well;

[0043] 3) Add povidone and mix to make a soft material, granulate with a 18-30 mesh sieve, and dry the granules at 50-80°C;

[0044] 4) When the granules are dried to moisture <5%, sieve the granules with 20 mesh;

...

Embodiment 2

[0048] Example 2: Perampanel dispersible tablet, the composition is as follows:

[0049] Perampanel 10g

[0050] Lactose 40g

[0051] Microcrystalline Cellulose PH10123g

[0052] Croscarmellose Sodium 20g

[0053] Magnesium stearate 1g

[0054] Povidone 3g

[0055] Acesulfame K 3g

[0056] Made in 1000 pieces.

[0057] The preparation method is as follows:

[0058] 1) Micronize perampanel, and its particle size distribution D90 is less than 10 μm; the auxiliary materials are passed through a 100-mesh sieve, and set aside;

[0059] 2) Weigh lactose, microcrystalline cellulose PH101, and internally added croscarmellose sodium according to the prescription amount, add the prescription amount of perampanel, and mix well;

[0060] 3) Add povidone and mix to make a soft material, granulate with a 18-30 mesh sieve, and dry the granules at 50-80°C;

[0061] 4) When the granules are dried to moisture <5%, sieve the granules with 20 mesh;

[0062] 5) Calculate the yield, add...

Embodiment 3

[0065] Example 3: Perampanel dispersible tablet, the composition is as follows:

[0066] Perampanel 12g

[0067] Lactose 40g

[0068] Microcrystalline Cellulose PH10123g

[0069] Croscarmellose Sodium 20g

[0070] Sodium stearyl fumarate 1g

[0071] Povidone 2g

[0072] Aspartame 2g

[0073] Made in 1000 pieces.

[0074] The preparation method is as follows:

[0075] 1) Micronize perampanel, and its particle size distribution D90 is less than 10 μm; the auxiliary materials are passed through a 100-mesh sieve, and set aside;

[0076] 2) Weigh lactose, microcrystalline cellulose PH101, and internally added croscarmellose sodium according to the prescription amount, add the prescription amount of perampanel, and mix well;

[0077] 3) Add povidone and mix to make a soft material, granulate with a 18-30 mesh sieve, and dry the granules at 50-80°C;

[0078] 4) When the granules are dried to moisture <5%, sieve the granules with 20 mesh;

[0079] 5) Calculate the yield, add...

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PUM

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Abstract

The invention relates to a perampanel dispersible tablet and a preparation method thereof, and belongs to the technical field of medicine. The perampanel dispersible tablet consists of the following components in percentage by weight: 1-15% of perampanel, 20-90% of filler, 10-80% of a disintegrating agent, 1-10% of lubricating agent and a flow aid, 1-10% of a binding agent and 0-10% of a flavoring agent, and the perampanel dispersible tablet undergoes a wet granulation process, wherein the crude perampanel medicine is micronized, so that D90 is less than 50 microns, and preferably D90 is less than 10 microns; and by controlling the grain size of the perampanel, the dissolution rate of the perampanel dispersible tablet can be significantly improved. In clinical field, the dispersible tablet is mainly used for treating partial patients of paroxysmal epilepsy in 12-years old and elder. The dispersible tablet is stable in quality, conducive to the dissolution and the absorption of medicines and is rapid to take effects. The dispersible tablet, which is convenient to take, can be orally taken after being dispersed in water and can be sucked and swallowed in a mouth.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a perampanel dispersible tablet and a preparation method thereof. The perampanel dispersible tablet can be used to treat partial-onset epilepsy patients aged 12 and over. Background technique [0002] Epilepsy is a chronic recurrent short-term brain dysfunction syndrome characterized by repeated epileptic seizures caused by abnormal discharge of brain neurons. Epilepsy is one of the common diseases of the nervous system, second only to stroke in prevalence. According to the latest epidemiological data in China, the overall prevalence rate of epilepsy in China is 7.0‰, the annual incidence rate is 28.8 / 100,000, and the prevalence rate of active epilepsy with seizures within one year is 4.6‰. Based on this, it is estimated that there are about 9 million epilepsy patients in China, of which 5 to 6 million are active epilepsy patients, and about 400,000 new epile...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/444A61K47/38A61P25/08
Inventor 张庭马莉
Owner 万全万特制药(厦门)有限公司
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