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Perampanel gastric-soluble micro pellets and preparation method thereof

A micro-pill tablet and stomach-dissolving technology, which is applied in the field of pharmacy, can solve the problems that patients cannot be effectively controlled, and achieve the effects of improving drug compliance, taking convenience, and swallowing

Inactive Publication Date: 2017-05-10
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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  • Perampanel gastric-soluble micro pellets and preparation method thereof
  • Perampanel gastric-soluble micro pellets and preparation method thereof
  • Perampanel gastric-soluble micro pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1 Preparation of perampanel gastric-dissolving pellets

[0043] 1.1 Prescription

[0044] A. Perampanel gastric-soluble pellets

[0045] Perampanel 12g Starch core 150g hypromellose 10g talcum powder 3g Gastric type coating powder 10g purified water 300g ethanol 100g

[0046] B. Perampanel gastro-soluble pellets

[0047]

[0048] 1.2 The method for preparing the above-mentioned prescription perampanel stomach-dissolving micropills is carried out according to the following steps:

[0049] 1) adding hypromellose to water, heating to make it completely dissolve, cooling, adding perampanel, and after it is completely dissolved, evenly dispersing talcum powder in the solution;

[0050] 2) placing the starch pellet core in a fluidized bed, and then spraying the solution in "1)" evenly on the surface of the starch pellet core with a fluidized bed device to make perampanel pellets;

[0051] 3) Dissolving the stoma...

Embodiment 2

[0057] Example 2 Preparation of perampanel gastric-soluble pellets

[0058] 2.1 Prescription

[0059] A. Perampanel gastric-soluble pellets

[0060] Perampanel 6g Starch core 100g hypromellose 8g talcum powder 3g Gastric type coating powder 10g purified water 250g ethanol 100g

[0061] B. Perampanel gastro-soluble pellets

[0062]

[0063] 2.2 The method for preparing the above-mentioned prescription perampanel gastric-dissolved pellets is carried out according to the following steps:

[0064] 1) adding hypromellose to water, heating to make it completely dissolve, cooling, adding perampanel, and after it is completely dissolved, evenly dispersing talcum powder in the solution;

[0065] 2) placing the starch pellet core in a fluidized bed, and then spraying the solution in "1)" evenly on the surface of the starch pellet core with a fluidized bed device to make perampanel pellets;

[0066] 3) Dissolving the stomach-solubl...

Embodiment 3

[0072] Example 3 Preparation of perampanel gastric-dissolving pellets

[0073] 3.1 Prescription

[0074] A. Perampanel gastric-soluble pellets

[0075] Perampanel 24g Starch core 100g hypromellose 6g talcum powder 3g Gastric type coating powder 10g purified water 260g ethanol 150g

[0076] B. Perampanel gastro-soluble pellets

[0077]

[0078] 3.2 The method for preparing the above-mentioned prescription perampanel gastric-dissolved pellets is carried out according to the following steps:

[0079] 1) adding hypromellose to water, heating to make it completely dissolve, cooling, adding perampanel, and after it is completely dissolved, evenly dispersing talcum powder in the solution;

[0080] 2) placing the starch pellet core in a fluidized bed, and then spraying the solution in "1)" evenly on the surface of the starch pellet core with a fluidized bed device to make perampanel pellets;

[0081] 3) Dissolving the stomach-so...

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Abstract

The invention discloses perampanel gastric-soluble micro pellets and a preparation method thereof. The preparation method comprises the following steps: preparing gastric-soluble coated pellets from perampanel serving as a main drug through a fluidized bed coating process, and then mixing the coated pellets with a filler, a disintegrating agent, an adhesive, a plasticizer and a lubricating agent to prepare the gastric-soluble pellets through a dry flaking technology. The pellets can be either directly swallowed or quickly disintegrated into the micro pellets in water, so that the perampanel gastric-soluble micro pellets are convenient for patients having trouble in swallowing, particularly children. The perampanel gastric-soluble micro pellets belong to a dosage form which can guarantee the accuracy of dosage and is safe and convenient to take.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to a micropill, in particular to a perampanel stomach-soluble micropill 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 mechanism o...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/444A61K47/38A61P25/08
CPCA61K9/2866A61K9/2081A61K31/444A61K47/38
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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