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Pharmaceutical composition of levetiracetam sustained-release tablet and its quality control and preparation method

A levetiracetam acid, sustained-release tablet technology, applied in the field of levetiracetam sustained-release tablet pharmaceutical composition and its quality control and preparation method, can solve the impurity of levetiracetam acid that cannot be tableted Satisfactory results have been achieved in the control of the growth rate, the proportion is large, and the coating layer is prone to cracks, etc.

Active Publication Date: 2020-01-07
HUNAN DONGTING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] It has been found that the above-mentioned prior art solutions cannot achieve satisfactory results in the improvement of tablet hardness and the control of the growth rate of levetiracetam acid impurities
In addition, due to the excellent water solubility of levetiracetam, the solubility in water is as high as 1.04g / ml, and the proportion of the main component in the tablet is too large (usually greater than 50%), in this case, the erodible type is used. Hydrophilic gel matrix materials such as hypromellose are preferred as sustained-release materials. However, it has been found that tablets prepared with water-soluble excipients and water-soluble main ingredients are prone to cracks in the coating layer after experiencing high temperature and high humidity.

Method used

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  • Pharmaceutical composition of levetiracetam sustained-release tablet and its quality control and preparation method
  • Pharmaceutical composition of levetiracetam sustained-release tablet and its quality control and preparation method
  • Pharmaceutical composition of levetiracetam sustained-release tablet and its quality control and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0134] Embodiment 1: the preparation of levetiracetam sustained-release tablet

[0135] Tablet prescription:

[0136]

[0137] Preparation method: (1) making levetiracetam pre-crushed into a powder that can pass through a 100-mesh sieve, and making the rest of the materials pre-crushed into a powder that can pass through an 80-mesh sieve;

[0138] (2) Mix levetiracetam with the diluent and a part of the sustained-release framework material (the weight ratio of the part of the sustained-release framework material to the diluent is 0.75:1), spray in a fluidized state Enter 90% ethanol solution (its consumption is 4% of fluidized solid material weight) to make this mixed material bond into granule, make it seal and place 24 hours;

[0139] (3) Continue to fluidize to remove the ethanol solution (to the extent that the moisture content of the particles drops below 2%), then extrude the resulting material into a block through an extruder, and then crush the powder so that it ca...

Embodiment 2

[0144] Embodiment 2: the preparation of levetiracetam sustained-release tablet

[0145] Tablet prescription:

[0146] Levetiracetam 500mg, Maltitol 50mg, Hypromellose K4M 170mg, Magnesium stearate 4 mg, Micropowder silica gel 2 mg;

[0147] Preparation method: (1) making levetiracetam pre-crushed into a powder that can pass through a 100-mesh sieve, and making the rest of the materials pre-crushed into a powder that can pass through an 80-mesh sieve;

[0148] (2) Mix levetiracetam with the diluent and a part of the sustained-release matrix material (the weight ratio of the part of the sustained-release matrix material to the diluent is 0.5:1), and spray in a fluidized state Enter 85% ethanol solution (its consumption is 6% of fluidized solid material weight) to make this mixed material bond into granule, make it seal and place 24 hours;

[0149] (3) Continue to fluidize to remove the ethanol solution (to the extent that the moist...

Embodiment 3

[0154] Embodiment 3: the preparation of levetiracetam sustained-release tablet

[0155] Tablet prescription:

[0156] Levetiracetam 500mg, Maltitol 30mg, Hypromellose K4M+K100M (5:1) 220mg, Magnesium stearate 2 mg, Micropowder silica gel 4 mg;

[0157] Preparation method: (1) making levetiracetam pre-crushed into a powder that can pass through a 100-mesh sieve, and making the rest of the materials pre-crushed into a powder that can pass through an 80-mesh sieve;

[0158] (2) Mix levetiracetam with the diluent and a part of the sustained-release matrix material (the weight ratio of the part of the sustained-release matrix material to the diluent is 1:1), and spray it in a fluidized state. Enter 88% ethanol solution (its consumption is 3% of fluidized solid material weight) and make this mixed material bond into granule, make it seal and place 24 hours;

[0159] (3) Continue to fluidize to remove the ethanol solution (to the extent...

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Abstract

The invention relates to a levetiracetam sustained release tablet drug composition and quality control and preparation method thereof, in particular to a method for detecting the quality of a levetiracetam sustained release tablet. The method comprises the following steps: determining the content of active component levetiracetam in the levetiracetam sustained release tablet and the content of impurity levetiracetam acid by utilizing a high-performance liquid phase chromatography, wherein the levetiracetam sustained release tablet is formed by a tablet core and a thin-film coating layer covering the surface of the tablet core, and the tablet core comprises levetiracetam, a sustained release skeleton material, a sustained release agent, a flow aid and a lubricating agent. The invention also relates to a pharmaceutical application of the levetiracetam sustained release tablet. The medicinal composition has good pharmaceutical characteristics and can be used for treating or preventing epilepsy, Parkinson disease, dyskinesia, migraine, tremor, essential tremor, bipolar disorder, chronic pain, neuropathic pain, or bronchus, asthma or allergic diseases.

Description

technical field [0001] The invention relates to a novel pharmaceutical composition containing levetiracetam sustained-release tablets, a quality control method and a preparation method thereof. The levetiracetam sustained-release tablet prepared by the invention has excellent properties. Background technique [0002] European patent EP0162036B discloses a kind of levorotatory compound levetiracetam (Levetiracetam), and its chemical name is (S)-(-)-[α]-ethyl-2-oxo-1-pyrrolidineacetamide, ( -)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide. Molecular formula C8H14N2O2, molecular weight 170.21, its chemical structure is as follows: [0003] [0004] Levetiracetam is white to off-white crystalline powder, which is easily soluble in water (1.04g / mL), chloroform (653mg / mL) and methanol (536mg / mL), dissolved in ethanol (165mg / mL), slightly Soluble in acetonitrile (57mg / mL). [0005] Levetiracetam is a cholinergic agonist. The drug is very effective in animal models of epileptic ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N11/14G01N30/02G01N30/06A61K9/36A61K9/30A61K47/38A61K47/26A61K31/4015A61P25/08A61P25/16A61P25/14A61P25/24A61P25/18A61P25/22A61P25/06A61P25/02A61P25/00A61P9/10A61P9/06A61P21/02A61P7/04A61P11/06A61P11/00A61P37/08A61P11/02A61P21/00
CPCA61K9/0002A61K9/2018A61K9/2054A61K9/2853A61K9/2866A61K31/4015G01N11/14G01N30/02G01N30/06
Inventor 侯奇伟谢亮王波郭杰李晓云
Owner HUNAN DONGTING PHARMA
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