Preparation composition containing lamotrigine and preparation method thereof

The technology of lamotrigine and composition is applied in the field of preparation compositions containing lamotrigine, and can solve the problems of expensive laser drilling equipment, high production threshold and high equipment requirements

Active Publication Date: 2021-05-28
SHIJIAZHUANG YILING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, "Diffcore" technology requires high equipment, laser drilling equipment is expensive, domestic drilling technology is not yet popular, the production threshold is high, and the production cost is high. It is difficult for the majority of patients to obtain this product at a lower price.

Method used

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  • Preparation composition containing lamotrigine and preparation method thereof
  • Preparation composition containing lamotrigine and preparation method thereof
  • Preparation composition containing lamotrigine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] This embodiment provides a sustained-release tablet containing lamotrigine, wherein the proportion of the coloring agent accounts for 7.08% of the dry material weight of the outer layer coating; the specific composition of its raw materials is as follows:

[0051]

[0052]

[0053] Remarks: In the Eudragit L30D-55 aqueous dispersion, the solid content is 30% (w / w).

[0054] The present embodiment further provides the preparation method of the sustained-release tablet, specifically:

[0055] (1) Preparation of tablet core:

[0056] 1) Take by weighing lamotrigine, hypromellose, purified water and magnesium stearate according to the batch dosage in the above table;

[0057] 2) Lamotrigine and hydroxypropyl methylcellulose were passed through a 20-mesh sieve in turn, and then placed in a 4L high-speed shear wet granulator, and the stirring blade was turned on at a speed of 300 rpm, and mixed for 10 minutes;

[0058] 3) The rotation speed of the stirring paddle is s...

Embodiment 2

[0079] This embodiment provides a sustained-release tablet containing lamotrigine, wherein the proportion of the coloring agent accounts for 3.04% of the dry material weight of the outer layer coating; the specific composition of the raw materials is as follows:

[0080]

[0081] The preparation method is the same as in Example 1.

Embodiment 3

[0083] This embodiment provides a sustained-release tablet containing lamotrigine, wherein the proportion of the coloring agent accounts for 0.43% of the weight of the dry material of the outer layer coating; the specific composition of the raw materials is as follows:

[0084]

[0085]

[0086] The preparation method is the same as in Example 1.

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Abstract

The invention relates to a preparation composition containing lamotrigine. The preparation composition comprises a tablet core and an outer coating, wherein the outer coating contains a coloring agent with a mass percent of 0.1-15%. According to the invention, the coloring agent with a specific proportion is added into the outer coating, so a drug release curve can be adjusted, the in-vitro release curve of the preparation composition is similar to the in-vitro release curve of a commercially available product without punching or addition of any pore-foaming agent, and the in-vivo bioequivalence of a human body is ensured, so the requirement of drug replacement in clinical treatment is met, and production cost is greatly reduced.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation composition containing lamotrigine. Background technique [0002] Lamotrigine (Lamictal, Lamictar) was originally discovered and developed by GlaxoSmithKline (GSK), and its products are sold in more than 90 countries around the world. The chemical name of lamotrigine is 3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine, the molecular weight is 256.09, and the molecular formula is: [0003] [0004] Lamotrigine is very slightly soluble in dichloromethane (<0.1mg / mL, 25℃), ethyl acetate (<0.1mg / mL, 25℃) and water (0.17mg / mL, 25℃), slightly soluble in Methanol (11.1 mg / mL, 25°C), ethanol (1.1 mg / mL, 25°C), and 0.1M HCl (4.1 mg / mL, 25°C). [0005] Lamotrigine as an oral sodium channel blocker and phenylalotriazine antiepileptic drug for partial seizures, Lennox-Gastaut syndrome generalized seizures, and primary generalized tonic-clonic seizures (PG...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/32A61K9/22A61K31/53A61K47/38A61P25/08
CPCA61K31/53A61K9/2866A61K9/284A61K9/2054A61P25/08Y02A50/30
Inventor 吴以岭吴相君贾振华齐宜广袁兴利汪磊
Owner SHIJIAZHUANG YILING PHARMA
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