Perampanel coated tablet pharmaceutical composition

A composition and medicine technology, applied in the preparation of perampanel-coated tablet pharmaceutical compositions with excellent pharmaceutical properties, and the field of tablets containing perampanel, which can solve the problems that patients cannot be effectively controlled and the like

Active Publication Date: 2017-02-15
HANGZHOU ZHUYANGXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] 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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  • Perampanel coated tablet pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0160] Embodiment 1: Preparation of perampanel tablets

[0161] Prescription (tablet core):

[0162] Perampanel 6mg,

[0163] Lactose 65mg,

[0164] Starch 15mg,

[0165] Microcrystalline Cellulose 25mg,

[0166] Low-substituted hydroxypropyl cellulose 15mg,

[0167] Polyvinylpyrrolidone 6mg,

[0168] Magnesium stearate 0.75mg.

[0169] Coating material prescription: 15 parts by weight of hydroxypropyl methylcellulose, 3 parts by weight of polyethylene glycol, 1 part by weight of talcum powder, 1 part by weight of titanium dioxide, 0.2 part by weight of ferric oxide, prepared with water to make a solid concentration of 5 % of coating solution.

[0170] Chip method:

[0171] (i) each material is crushed in advance to powder that can pass through a 120 mesh sieve;

[0172] (ii) Mix perampanel, starch and microcrystalline cellulose uniformly, use water as lubricant in the mixing and stirring granulator to prepare wet granules for the mixed material, and dry until the mo...

Embodiment 2

[0185] Embodiment 2: Preparation of perampanel tablets

[0186] Prescription (tablet core):

[0187] Perampanel 12mg,

[0188] Lactose 80mg,

[0189] Starch 20mg,

[0190] Microcrystalline cellulose 20mg,

[0191] Low-substituted hydroxypropyl cellulose 20mg,

[0192] Polyvinylpyrrolidone 8mg,

[0193] Magnesium stearate 1mg.

[0194] Coating material prescription: 12 parts by weight of hydroxypropyl methylcellulose, 4 parts by weight of polyethylene glycol, 1 part by weight of talcum powder, 1 part by weight of titanium dioxide, 0.2 parts by weight of aluminum lake, prepared with water to a solid content concentration of 5%. coating solution.

[0195] Chip method:

[0196] (i) each material is crushed in advance to powder that can pass through a 120 mesh sieve;

[0197] (ii) Mix perampanel, starch and microcrystalline cellulose uniformly, use water as lubricant in the mixing and stirring granulator to prepare wet granules for the mixed material, and dry until the moi...

Embodiment 3

[0202] Embodiment 3: Preparation of perampanel tablets

[0203] Prescription (tablet core):

[0204] Perampanel 2mg,

[0205] Lactose 50mg,

[0206] Starch 10mg,

[0207] Microcrystalline cellulose 30mg,

[0208] Low-substituted hydroxypropyl cellulose 10mg,

[0209] Polyvinylpyrrolidone 4mg,

[0210] Magnesium stearate 0.5 mg.

[0211] Coating material prescription: 15 parts by weight of hydroxypropyl methylcellulose, 5 parts by weight of polyethylene glycol, 1 part by weight of talcum powder, 1 part by weight of titanium dioxide, 0.2 part by weight of ferric oxide, prepared with water to make the solid content concentration 7 % of coating solution.

[0212] Chip method:

[0213] (i) each material is crushed in advance to powder that can pass through a 120 mesh sieve;

[0214] (ii) Mix perampanel, starch and microcrystalline cellulose uniformly, use water as lubricant in the mixing and stirring granulator to prepare wet granules for the mixed material, and dry unti...

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Abstract

The invention relates to a perampanel coated tablet pharmaceutical composition, in particular to a pharmaceutical composition in the form of tablets. The pharmaceutical composition comprises perampanel, an excipient, a disintegrating agent, a binder and a lubricant, wherein the excipient is selected from lactose, sucrose, glucose, corn starch, mannitol, sorbitol, starch, calcium hydrogen phosphate and the like, the disintegrating agent is selected from agar, calcium citrate, dextrin, low-substituted hydroxypropyl cellulose, carboxymethyl cellulose, calcium carboxymethyl cellulose, croscarmellose sodium, carboxymethyl starch, carboxymethyl starch sodium and the like, the binder is selected from polyvinyl alcohol, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose, hydroxy propyl cellulose, sodium carboxymethyl cellulose, polyvinylpyrrolidone, polyethylene glycol and the like, and the lubricant is selected from magnesium stearate, calcium stearate, talcum powder, polyethylene glycol, colloidal silicon dioxide and the like. The invention further relates to a preparation method and application of the composition. The pharmaceutical composition has excellent properties 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 coated tablets with chemical properties. 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] Epilepsy is a chronic recurrent short-term brain dysfunction syndrome characterized by repeated epileptic seizures caused by abnormal discharge of brain neurons. Epilepsy is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/444A61K9/16A61K47/38A61P25/08
CPCA61K9/1652A61K9/2054A61K31/444
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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