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Perampanel tablet medicinal composition capable of rapidly disintegrating

A composition and tablet technology, applied in the pharmaceutical field, can solve the problems of easy fragmentation, inability to perform tableting, inspection, etc.

Active Publication Date: 2018-01-23
HANGZHOU ZHUYANGXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is well known that it is extremely difficult for the orally disintegrating tablet prepared by the freeze-drying process to maintain the shape of the tablet, the hardness and friability of the tablet cannot be checked, and it is easy to fragment during storage and transportation, and the tablet very hygroscopic

Method used

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  • Perampanel tablet medicinal composition capable of rapidly disintegrating

Examples

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Comparison scheme
Effect test

Embodiment 1

[0163] Example 1: Preparation of Perampanel Orally Disintegrating Tablets

[0164] (1) Dissolve / suspend 1000 g of perampanel (through a 200-mesh sieve) and 200 g of hydroxypropyl methylcellulose in 4000 g of purified water. Microcrystalline cellulose particles (Celphere102, Asahi Kasei, average particle diameter is about 120 μm, more than 95% of the particle diameter is in the range of 50-150 μm) 3000g is put into a fluidized bed granulator, and the solution is packaged with the side spray method. clothing, to obtain perampanel particles.

[0165] The fluidized bed granulator above and in the context of the present invention is the WBF-60 fluidized bed granulator produced by Chongqing Yingge Granulation Coating Technology Co., Ltd. When using this fluidized bed granulator for granulation and / or coating, according to different materials, the spray speed can usually be controlled in the range of 10-100g / min, and the spray air pressure can usually be controlled in the range of ...

Embodiment 2

[0188] Example 2: Preparation of Perampanel Orally Disintegrating Tablets

[0189] (1) Dissolve / suspend 250 g of perampanel (through a 200-mesh sieve) and 100 g of hydroxypropyl methylcellulose in 2000 g of purified water. Put microcrystalline cellulose microparticles (Celphere102, Asahi Kasei, average particle diameter is about 150 μm, more than 95% of the particle diameter is in the range of 100-220 μm) 4000g into a fluidized bed granulator, and use this solution to pack clothing, to obtain perampanel particles.

[0190] (2) Put 4,000 g of the perampanel particles into a fluidized bed granulator, and coat them with hydroxypropyl methylcellulose-based film coating solution (purchased from Colorcon) by side spraying. Coating, obtain the pellet of wrapping film coating, coating weight gain 8%.

[0191] (3) 350 g of the coated pellets, 2400 g of mannitol, 650 g of lactose, and 200 g of sodium citrate were granulated in a fluidized bed granulator with a 30% w / w aqueous soluti...

Embodiment 3

[0200] Example 3: Preparation of Perampanel Orally Disintegrating Tablets

[0201] (1) Dissolve / suspend 750 g of perampanel (through a 200-mesh sieve) and 100 g of polyvinylpyrrolidone in 2000 g of purified water. Microcrystalline cellulose particles (Celphere102, Asahi Kasei, average particle diameter is about 100 μm, more than 95% of the particle diameter is in the range of 70-180 μm) 4000g is put into a fluidized bed granulator, and the solution is packaged with the side spray method. clothing, to obtain perampanel particles.

[0202] (2) Next, add 600 g of ethyl cellulose (ground and pass through a 200-mesh sieve) and 200 g of hydroxypropyl methylcellulose into 20,000 g of water, suspend the ethyl cellulose strongly and dissolve HPMC to obtain a slow Release the coating suspension. Put 4000 g of perampanel particles into a fluidized bed granulator, and coat with the coating solution by side spraying method to obtain sustained-release pellets.

[0203] (3) 300g of the ...

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Abstract

The invention relates to a perampanel tablet medicinal composition capable of rapidly disintegrating. Specifically, the invention relates to a medicinal composition in the form of the tablet, the medicinal composition can disintegrate in the oral cavity, and the tablet is prepared through pressing by adopting a tabletting process. The tablet comprises a tablet matrix formed by various auxiliary materials, and a plurality of coating pellets basically uniformly dispersed in the tablet matrix; each coating pellet comprises a pellet core containing the active ingredient, namely, perampanel, and atleast one layer of coating covering the surface of the pellet core; the coating is a film coating layer, a gastric-soluble coating layer, an enteric-soluble coating layer or a sustained coating layer, or the coating comprises two layers, respectively the sustained coating layer and the enteric-soluble coating layer from inside to outside. The invention further relates to a preparation method andapplications of the medicinal composition. The medicinal composition provided by the invention has the excellent technical effects as described in the description.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and relates to a method for preparing a medicament for treating mental illness, in particular to a method for preparing a tablet containing perampanel for treating epilepsy, and more particularly to a method for preparing a medicament with excellent Method for pharmaceutical composition of perampanel tablet with excellent disintegration properties in particular. Perampanel has been successfully used clinically as an adjuvant treatment for partial seizures in epileptic patients over 12 years old, regardless of whether the patients have secondary generalized seizures. In addition, perampanel has been successfully used clinically for Primary generalized tonic-clonic seizures in epileptic patients older than 12 years. Background technique [0002] In order to improve the convenience of drug use and solve the medication compliance of specific indications and special patient populations, the pharmace...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/50A61K47/38A61K47/26A61K31/444A61P25/08
Inventor 李阅东沈如杰何海珍郭艳超刘秋敏马雯霞
Owner HANGZHOU ZHUYANGXIN PHARMA
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