Preparation method for lamotrigine oral solution

A technology of lamotrigine and oral solution, applied in the field of medicine, can solve the problems of non-compliance with oral treatment, effect influence, poor oral treatment and the like

Inactive Publication Date: 2015-09-02
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

This leads to poor oral therapy or even non-compliant oral thera

Method used

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  • Preparation method for lamotrigine oral solution

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Table 1. The oral solution of embodiment one

[0064] Element mg / ml Lamotrigine 2.5 PEG-400 125 DL-lactic acid 8.47 sodium hydroxide Appropriate amount benzoic acid 1.5 sucrose 360 fructose 350 Natural Orange Juice Flavoring 3.0 purified water Appropriate amount

[0065] 1. Fill PEG-400 and a part of purified water (80-90%) into the ingredient container. With continuous moderate agitation, add DL-Lactic Acid to the ingredient container and mix until it dissolves.

[0066] 2. With continuous moderate agitation, add lamotrigine to step 1 ingredient container and mix. All powders were confirmed to have dissolved by visual inspection.

[0067] 3. With continuous moderate stirring, 2.5N sodium hydroxide solution was added thereto to adjust the pH of the material from step 3 between 2.4-2.7.

[0068] 4. With continuous moderate agitation, heat the material from step 3 to 45-55°C. Then, benzoic acid was...

Embodiment 2

[0077] Table 2. The oral solution of embodiment two

[0078] Element mg / ml Lamotrigine 2.5 glycerin 150 DL-lactic acid 8.47 sodium hydroxide Appropriate amount Propylene Glycol 50 Methylparaben 1.8 Propylparaben 0.2 sucrose 400 fructose 200 Natural Orange Juice Flavoring 3.0 purified water Appropriate amount

[0079] 1. Fill PEG-400 and a part of purified water (80-90%) into the ingredient container. With continuous moderate agitation, add DL-Lactic Acid and a portion of Propylene Glycol to the ingredient container and mix until dissolved.

[0080] 2. In a container, disperse the methylparaben and propylparaben in a portion of the propylene glycol and mix them.

[0081] 3. With continuous moderate agitation, add lamotrigine to step 1 ingredient container and mix. All powders were confirmed to have dissolved by visual inspection.

[0082] 4. With continuous moderate stirring, 2.5N sodium hydro...

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Abstract

The invention provides a medicine solution suitable for oral administration. The preparation method for a lamotrigine oral solution comprises lamotrigine or a lamotrigine eutectic matter which can improve the solubility, a suitable medicinal solvent system, one or multiple flavour masking agents, one or multiple preservatives, one or multiple matters selecting from lactic acid, acetic acid, tartaric acid and citric acid and the like. The lamotrigine oral solution has the PH value ranging from two to four. The lamotrigine oral solution can be used for treating epilepsy and bipolar disorder, especially for a patient who suffers from dysphagia and for improving the compliance of a patient sufferring from the bipolar disorder.

Description

technical field [0001] The present invention belongs to the field of medicine, in particular to a pleasant-tasting and easy-to-administer oral solution comprising lamotrigine or a lamotrigine co-crystal and useful for treating epilepsy and mood disorders such as bipolar disorder. Background technique [0002] Dysphagia or dysphagia due to fear of choking is common in all age groups. For example, in about 35% of the general population and another 30-40% of elderly institutionalized patients and 18-22% of all people in long-term care facilities Dysphagia is observed and many of these individuals require regular medication to maintain their quality of life. This leads to poor or even non-compliant oral therapy, thus having a negative impact on the effectiveness of the oral therapy. [0003] The main goals of treatment in the case of epileptic patients are to maintain adequate antiepileptic drug levels and to prevent subsequent seizures. In the case of patients with mood diso...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/53A61K47/12A61K47/34A61P25/08
Inventor 毛敏珏马莉
Owner AVENTIS PHARMA HAINAN
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