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Lamotrigine dry suspension and preparation method thereof

A technology of dry lamotrigine and lamotrigine, which is applied in the field of dry suspension of lamotrigine and its preparation, and can solve problems such as difficulty in accurate dosage of patients, difficulty in separating crystals, and difficulty in dispersing drugs

Active Publication Date: 2017-03-15
SHANGHAI AUCTA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no liquid preparation of lamotrigine on the market, so hospitals often need to crush lamotrigine tablets to prepare liquid preparations when using it, which is convenient for children and patients with dysphagia
[0004] Lamotrigine is poorly soluble in water. When the pulverized lamotrigine tablet is added to water, the drug will settle quickly and not easily disperse, which may affect the accuracy of the dosage
[0005] Chinese patents CN201510288845.X and CN201510350210.8 disclose the prescription and preparation method of lamotrigine oral solvent, but the concentration of the preparation is low (less than 2mg / ml), which cannot meet the clinical needs; Adding organic solvents is not conducive to children
[0006] In addition, the liquid preparation is also not ideal. When the applicant prepares the lamotrigine liquid suspension (10mg / ml), square crystals will be generated in the storage process, and the crystals generated are difficult to separate. The turbid situation of the solution occurs, which affects to the accuracy of dosing
In addition, when the applicant conducts the accelerated test of lamotrigine liquid suspension, the lamotrigine liquid suspension will produce impurities beyond the limit within the two-year validity period
[0007] Therefore present lamotrigine preparation, existing patient's dosage is difficult for accurate, and the physical and chemical property stability of liquid suspension is not good etc.

Method used

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  • Lamotrigine dry suspension and preparation method thereof
  • Lamotrigine dry suspension and preparation method thereof
  • Lamotrigine dry suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] Prescription 1

[0088]

[0089]

[0090] Dry powder mixing, the specific steps are:

[0091] 1. Pass the lamotrigine bulk drug and all auxiliary materials in the prescription through a 1016 micron sieve respectively.

[0092] 2. Weigh the prescribed amount of lamotrigine bulk drug and all auxiliary materials, put them in a mixer with a suitable size, and mix them for 10 minutes at a speed of 20 rpm.

[0093] 3. Use an automatic packaging machine to pack the prepared lamotrigine dry suspension. Obtain described lamotrigine dry suspension.

Embodiment 2

[0095] Adopt the prescription 1 of embodiment 1, use wet granulation.

[0096] The specific steps are:

[0097] 1. Pass the lamotrigine bulk drug and all auxiliary materials in the prescription through a 1016 micron sieve respectively.

[0098] 2. Weigh the prescribed amount of lamotrigine raw material and introverted excipients, mix them in a wet granulator with a suitable volume for 5 minutes, and then add an appropriate amount of water to granulate. The stirring shear rate of the wet granulator is 300rpm, and the granulation time is 5 minutes.

[0099] 3. After wet sizing with a sieve of 6350 microns, dry at 50°C in a fluidized bed until LOD<2%.

[0100] 4. Use a 1016um sieve to dry the granules, and place the prescribed amount of external excipients in a mixer with a suitable volume, and mix for 10 minutes at a speed of 20 rpm.

[0101] 5. Use an automatic packaging machine to pack the prepared lamotrigine dry suspension. Obtain described lamotrigine dry suspension.

Embodiment 3

[0103] Prescription 2

[0104]

[0105]

[0106] Prepared by the dry powder mixing method of Example 1.

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Abstract

The invention discloses a lamotrigine dry suspension. The lamotrigine dry suspension comprises lamotrigine and other pharmaceutical-grade auxiliary materials, wherein the auxiliary materials include a filling agent, a suspending aid, a buffer agent, a sweetening agent, a flavor agent and a flow aid. The lamotrigine dry suspension has the advantages of liquid suspensions that the taste of medicines is improved, the medicines are easy to be taken, and the stability of medication dosage is improved; furthermore, the chemical and physical stabilities of a preparation can be improved, and the quality of the lamotrigine dry suspension is improved.

Description

technical field [0001] The invention specifically relates to a lamotrigine dry suspension and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] The trade name of lamotrigine in the United States is Lamictal, which is a product of GlaxoSmithKline. It mainly treats epilepsy disorders in children and adults. [0003] Currently, the U.S. Food and Drug Administration has approved three different dosage forms of Lamictal, which are regular tablets, chewable tablets and orally disintegrating tablets. There is no liquid preparation of lamotrigine on the market, so hospitals often need to crush lamotrigine tablets to prepare liquid preparations when using it, which is convenient for children and patients with dysphagia. [0004] Lamotrigine is poorly soluble in water. When the pulverized lamotrigine tablet is added to water, the medicine will settle quickly and not easily disperse, which may affect the accuracy of the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/16A61K47/36A61K31/53A61P25/08
CPCA61K9/146A61K9/1652A61K31/53
Inventor 卢恩先李守峰张维王勇王众勤
Owner SHANGHAI AUCTA PHARMA CO LTD
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