Lacosamide oral solution and preparation method thereof

A technology for lacosamide and oral solution, which is applied in the field of pharmaceutical preparations, can solve the problems of difficulty in preparing oral solution, complex preparation process, many preparation impurities, etc., and achieves the effects of simple and efficient preparation process, stable properties and improved solubility

Pending Publication Date: 2020-12-04
JIANMIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because lacosamide and certain auxiliary materials for preparing oral solutions are difficult to dissolve in water and have uneven concentrations after standing still, the preparation process has certain complexity, and there are many known impurities in the preparation, it is difficult to prepare oral solutions that meet relevant standards.

Method used

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  • Lacosamide oral solution and preparation method thereof
  • Lacosamide oral solution and preparation method thereof
  • Lacosamide oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] This embodiment provides a lacosamide oral solution, which is prepared by including the raw materials in Table 1.

[0031] Lacosamide oral solution components in Table 1 Example 1

[0032]

[0033] The preparation method of the lacosamide oral solution of the present embodiment comprises the following steps:

[0034] S1, add 450g purified water in the stirring tank, open stirring;

[0035] S2, after wetting the flavoring agent maltol with 3g purified water, put it into the tank, and stir until it is completely dissolved;

[0036] S3, the thickening agent sodium carboxymethyl cellulose added slowly is stirred until dispersion and swelling are complete;

[0037] S4, the citric acid, sorbitol, aspartame, acesulfame potassium, macrogol 4000, glycerol, propylene glycol and sodium paraben added successively, stirring until dissolving completely;

[0038] S5, add lacosamide, add purified water to 950 mL, and stir until dissolved completely;

[0039] S6, add strawberry e...

Embodiment 2

[0044] This embodiment provides a lacosamide oral solution, which is prepared by including the raw materials in Table 2.

[0045] Table 2 Lacosamide oral solution components in Example 2

[0046]

[0047] The preparation method of the lacosamide oral solution of the present embodiment comprises the following steps:

[0048] S1, add 450g purified water in the stirring tank, open stirring;

[0049] S2, after wetting the ethyl maltol with 3g of purified water, put it into the tank, and stir to dissolve completely;

[0050] S3, the thickening agent sodium carboxymethyl cellulose added slowly is stirred until dispersion and swelling are complete;

[0051] S4, the citric acid, maltitol, xylitol, sodium saccharin, polyethylene glycol 4000, sodium paraben added successively are stirred to dissolve completely;

[0052] S5, add lacosamide, add purified water to 950 mL, and stir until dissolved completely;

[0053] S6, add banana essence, and set the volume to 1L;

[0054] S7, fi...

Embodiment 3

[0058] This embodiment provides a lacosamide oral solution, which is prepared from the raw materials included in 3.

[0059] Table 3 Lacosamide oral solution components in Example 3

[0060]

[0061] The preparation method of the lacosamide oral solution of the present embodiment comprises the following steps:

[0062] S1, add 450g purified water in the stirring tank, open stirring;

[0063] S2, after wetting the maltol with 3g of purified water, put it into the tank, and stir until it is completely dissolved;

[0064] S3, slowly add sodium carboxymethyl cellulose, and stir until dispersion and swelling are complete;

[0065] S4, the malic acid, maltitol, sorbitol, sucrose, macrogol 4000, glycerol and propylene glycol, benzoic acid added successively are stirred to dissolve completely;

[0066] S5, add lacosamide, add purified water to 950 mL, and stir until dissolved completely;

[0067] S6, add apple essence, make up to 1L;

[0068] S7, filter;

[0069] S8, filling;...

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Abstract

The invention relates to a lacosamide oral solution. The lacosamide oral solution comprises lacosamide, a solubilizer, a thickener, a corrigent, an acidity regulator and a preservative, wherein the mass concentration of the lacosamide is 10mg / mL, the mass concentration of the solubilizer is 100-150mg / mL, the mass concentration of the thickener is 0.5-1.5 mg / mL, the mass concentration of the corrigent is 180-300mg / mL, the mass concentration of the acidity regulator is 1.9-4 mg / mL, the mass concentration of the preservative is 2-3mg / mL, and the balance is water. The pH value of the oral solutionis controlled to be 3.5-6.0 by adding the acidity regulator, the solubility of the lacosamide is improved by adding the solubilizer, and the stability of the oral solution is improved by adding the thickener, so that the lacosamide can be uniformly dispersed in the oral solution. The preparation method is simple and efficient.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a lacosamide oral solution and a preparation method. Background technique [0002] Epilepsy is a chronic disease caused by sudden abnormal discharge of neurons in the brain, resulting in transient brain dysfunction. According to the latest epidemiological data in China, the overall prevalence of epilepsy in China is 7.0‰, the annual incidence is 28.8 / 100,000, and the prevalence of active epilepsy with seizures within one year is 4.6‰. According to this, it is estimated that there are about 9 million epilepsy patients in China, of which 5 to 6 million are active epilepsy patients, and about 400,000 new epilepsy patients are added every year. Epilepsy has become the second most common neurological disease in China after headache. sick. [0003] Lacosamide, as the third-generation novel antiepileptic drug, has obvious therapeutic advantages and broad applicatio...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/165A61K47/10A61K47/12A61K47/26A61K47/22A61K47/38A61P25/08
CPCA61K31/165A61K9/0095A61K47/10A61K47/38A61K47/12A61K47/26A61K47/22A61P25/08
Inventor 余丽花任霞郭平吴雪英张梦婷黄珮闻凌骅卢琳
Owner JIANMIN PHARMA GRP CO LTD
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