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Lacosamide medicine oral preparation and preparation method thereof

A technology for lacosamide and oral preparations, applied in the field of medicine, can solve the problems of loose and brittle particles, unstable tableting, poor fluidity and the like, and achieve the effects of stable product quality, little impact and good safety.

Pending Publication Date: 2020-08-07
ZHEJIANG HUAHAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The purpose of the present invention is to solve the problems of loose and fragile particles after lacosamide granulation, more fine powder, poor fluidity, easy stratification of mixing and tableting, and unstable tableting; simultaneously simplify the process and make the granulation process window wider wide, reducing production costs and energy consumption, stable and controllable product quality, and more conducive to commercial production and process scale-up transfer

Method used

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  • Lacosamide medicine oral preparation and preparation method thereof
  • Lacosamide medicine oral preparation and preparation method thereof
  • Lacosamide medicine oral preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063]

[0064] Preparation Process:

[0065] (1) Lacosamide is mixed with pharmaceutical excipients microcrystalline cellulose, crospovidone, and hydroxypropyl cellulose in a wet granulation pot to obtain a premix; add purified water to the resulting premix Medium-made soft materials, the speed of the stirring blade is 200rpm, the speed of the cutter is 1500rpm, and the granulation time is 360s;

[0066] (2) passing the soft material obtained in step (1) through a 4-20 mesh screen to obtain wet particles;

[0067] (3) The wet granules obtained in the step (2) are dried in a fluidized bed until the weight loss on drying of the material is less than or equal to 3.0%, and the obtained material is passed through a 10-30 mesh screen to obtain dry granules, and then magnesium stearate is added for total mixing , have mixed particles;

[0068] (4) The mixed granules obtained in step (3) are compressed by a rotary tablet press, and II coating powder is used for coating, and th...

Embodiment 2

[0070]

[0071] Preparation process: with embodiment 1

Embodiment 3

[0073]

[0074] Preparation process: with embodiment 1

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Abstract

The invention provides a pharmaceutical oral preparation taking lacosamide as an active ingredient. The preparation is characterized in that a tablet core consists of the following pharmaceutical components, by weight: 25-60% of lacosamide, 10-65% of microcrystalline cellulose, 0.3-20% of hydroxy propyl cellulose, 1-30% of polyvinylpolypyrrolidone, and 0.3-2% of magnesium stearate, wherein the particle size distribution D (V, 0.9) of lacosamide is less than or equal to 80micron. In addition, the invention also provides a preparation method of the medicine oral preparation. In the process, theadhesive does not need to form a solution, and is directly added in a dry manner to be mixed and granulated with lacosamide and other auxiliary materials in a wet granulation pot. According to the lacosamide dry particles prepared by the technical scheme of the invention, the flowability is remarkably improved, the weight of the obtained tablets is stable, the dissolution and impurity change meetthe requirements, and the product quality is stable.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a preparation method of lacosamide oral preparations and tablets thereof. Background technique [0002] Lacosamide (Lacosamide) is a new third-generation antiepileptic drug, which is a slow-inactivating sodium ion channel blocker. Traditional antiepileptic drugs mainly act on the VGSC (voltage-gated sodium ion channel) in the fast inactivation state and prolong its inactivation time to terminate abnormal discharge, while lacosamide mainly acts on the slow inactivation sodium channel selectively, Promote the slow inactivation of VGSC and increase the proportion of VGSC in the slow inactivation state, which can reduce the excitability of neuron cell membrane, help to terminate the long-range high-frequency discharge in the process of epileptic discharge, and affect the short-term high-frequency discharge and normal brain function smaller. Another in vitro experiment...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K47/38A61K47/32A61K31/165A61P25/08
CPCA61K9/2866A61K9/2095A61K9/2054A61K9/2027A61K31/165A61P25/08
Inventor 聂倩兰彭俊清邵建华沈广青郭晓迪
Owner ZHEJIANG HUAHAI PHARMA CO LTD
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