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Perampanel sustained-release capsule and preparation method thereof

A slow-release capsule and slow-release coating technology, applied in capsule delivery, microcapsules, pharmaceutical formulations, etc., can solve the problem that patients cannot be effectively controlled

Inactive Publication Date: 2017-05-17
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

[0003] 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

[0019] Preparation of pill cores

[0020] 1. Preparation of the main drug coating solution: add 15 g of ethyl cellulose and 5 g of perampanel accurately weighed into the 60% ethanol solution, stir evenly, and filter the resulting suspension with a 80-mesh sieve to form a solid content 55% coating liquid, keep stirring when spraying liquid.

[0021] 2. Pour 21g of sucrose blank core into the coating pan and preheat it. When the internal temperature of the sucrose blank core reaches above 45°C, adjust the speed in the coating pan to about 20rpm, turn on the peristaltic pump and spray gun to start coating, The spray flow rate is controlled at 70-80g / min. After coating the main drug, open the air exhaust and air intake valves, the coating pan rotates at 5 rpm, and the drying heating temperature is 50°C, and is dried for 5 hours, and the pellets are passed through 12-mesh and 20-mesh sieves to obtain the product.

[0022] Preparation of isolation coating layer

[0023] 1. Add 3g...

Embodiment 2

[0033] Preparation of pill cores

[0034] 1. Preparation of the main drug coating solution: Add 20g of hypromellose and 10g of perampanel accurately weighed in purified water, stir evenly, and filter the resulting suspension with an 80-mesh sieve to form a solid content of 50%. coating solution, keep stirring while spraying.

[0035] 2. Pour 21g of sucrose blank core into the coating pan and preheat it. When the internal temperature of the sucrose blank core reaches above 45°C, adjust the speed in the coating pan to about 20rpm, turn on the peristaltic pump and spray gun to start coating, The spray flow rate is controlled at 70-80g / min. After coating the main drug, open the air exhaust and air intake valves, the coating pan rotates at 5 rpm, and the drying heating temperature is 50°C, and is dried for 5 hours, and the pellets are passed through 12-mesh and 20-mesh sieves to obtain the product.

[0036] Preparation of isolation coating layer

[0037] 1. Add 3g of polyethylen...

Embodiment 3

[0047] Preparation of pill cores

[0048] 1. Preparation of the main drug coating solution: Add 10g of polyethylene glycol 4000 and 15g of perampanel that are accurately weighed in purified water, stir evenly, and filter the resulting suspension with an 80-mesh sieve to form a solid content of 45%. coating solution, keep stirring while spraying.

[0049] 2. Pour 21g of sucrose blank core into the coating pan and preheat it. When the internal temperature of the sucrose blank core reaches above 45°C, adjust the speed in the coating pan to about 20rpm, turn on the peristaltic pump and spray gun to start coating, The spray flow rate is controlled at 70-80g / min. After coating the main drug, open the air exhaust and air intake valves, the coating pan rotates at 5 rpm, and the drying heating temperature is 50°C, and is dried for 5 hours, and the pellets are passed through 12-mesh and 20-mesh sieves to obtain the product.

[0050] Preparation of isolation coating layer

[0051] 1. ...

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PUM

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Abstract

The invention discloses a perampanel sustained-release capsule as well as a preparation method and application of the perampanel sustained-release capsule. The perampanel sustained-release capsule is prepared by filling a hollow capsule with perampanel sustained-release pellets, wherein each perampanel sustained-release pellet comprises a pellet core, an isolative coating layer, a sustained-release coating layer and a protective coating layer from inside to outside; and the pill core comprises the following components by weight percent: 3-10% of perampanel, 10-30% of an adhesive and 10-60% of a sucrose core pellet. According to the sustained-release preparation, the hold time of therapeutic concentration of the sustained-release capsule in vivo perampanel can be prolonged to 12 hours, the side effect caused by over-large fluctuation of blood concentration is reduced, meanwhile, the medication times are reduced, and the perampanel sustained-release capsule is significant in effect and convenient to use for a patient requiring epilepsy prevention.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a perampanel sustained-release capsule 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. [0003] 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 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/62A61K31/444A61K47/32A61K47/38A61P25/08A61P29/00
CPCA61K9/0002A61K9/5026A61K9/5047A61K9/5078A61K31/444
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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