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Eszopiclone oral disintegrating tablet and preparation method thereof

A technology for eszopiclone and orally disintegrating tablets is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, medical preparations containing active ingredients, etc. Problems such as slow dissolution rate

Active Publication Date: 2018-02-09
湖南中医药高等专科学校
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because the eszopiclone bulk drug itself is insoluble in water and the dissolution rate is slow, it is difficult to prepare orally disintegrating tablets, and eszopiclone has a bad smell, which can produce a strong and long-lasting bitter taste in the mouth, which is palatable. Poor performance, there is no orally disintegrating tablet of eszopiclone

Method used

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  • Eszopiclone oral disintegrating tablet and preparation method thereof
  • Eszopiclone oral disintegrating tablet and preparation method thereof
  • Eszopiclone oral disintegrating tablet and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1～9

[0085] The orally disintegrating tablet of eszopiclone provided by the present invention is prepared from raw materials and auxiliary materials, wherein the raw material is eszopiclone, and the auxiliary materials include PVPP, a mixture of mannitol 200SD and MCC, stevioside, magnesium stearate, manna The weight ratio of alcohol 200SD to MCC is 1:4, by weight percentage, the ratio of each component is shown in Table 7.

[0086] Table 7

[0087]

[0088]

[0089] The preparation method of eszopiclone orally disintegrating tablets in the above-mentioned embodiments 1-9 comprises the following steps:

[0090] S1. Put the eszopiclone and auxiliary materials into a universal pulverizer for 30-50 minutes and pulverize them to obtain powdery materials. Pass the eszopiclone through an 80-mesh sieve, sieve 3 times, and mix PVPP and mannitol 200 SD The mixture with MCC and stevioside are passed through a 30-mesh sieve, sieved for 3 times, and the eszopiclone and auxiliary materia...

Embodiment 10

[0097] (1) Verification test

[0098] Three batches of samples were prepared according to the formula ratio of eszopiclone orally disintegrating tablets in Example 9, and the appearance, taste, tablet weight difference, hardness, disintegration time limit, and eszopiclone content were detected according to the relevant quality requirements of orally disintegrating tablets. , the results are shown in Table 9.

[0099] Table 9 Quality evaluation of 3 batches of eszopiclone orally disintegrating tablets

[0100]

[0101] (2) Methodological investigation

[0102] In order to further investigate the performance of the prepared eszopiclone orally disintegrating tablets, specificity inspection, linear relationship inspection, precision test, stability test, repeatability test and sample recovery test were carried out respectively.

[0103] The experimental results show that: the specificity test shows that the excipients in the sample do not interfere with the main peak of eszop...

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Abstract

The invention relates to the technical filed of a medicine, and discloses an eszopiclone oral disintegrating tablet and a preparation method thereof. The eszopiclone oral disintegrating tablet is prepared by a bulk drug and excipients, wherein the weight percentage of the bulk drug to the excipients is 1-5%:95-99%, the eszopiclone oral disintegrating tablet comprises the following components by weight percentage: 1-5% of eszopiclone, 5-20% of a disintegrating agent, 70-90% of a filler, 1-5% of a flavouring, and 0.5-2.5% of a lubricant; wherein the sum of the weight percentage of the raw materials is 100%. By aiming at the disadvantages of difficult dissolution of eszopiclone in water, slow dissolution speed, and poor mouthfeel of eszopiclone, various excipients capable of promoting disintegration of the bulk drug eszopiclone and effectively covering the adverse smell of eszopiclone can be selected from many drugs, the obtained eszopiclone oral disintegrating tablet has the advantages of fast disintegration speed, short disintegration time, good palatability, smooth and clean surface, and no spot and the like. The oral disintegrating tablet is prepared by a direct tabletting method,the process is simple, and the economic benefit is good.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an orally disintegrating eszopiclone tablet and a preparation method thereof. Background technique [0002] Insomnia is one of the common clinical diseases. Although it is not a critical disease, it hinders people's normal life, work, study and health, and can aggravate or induce palpitations, chest obstruction, dizziness, headache, stroke and other diseases. Obstinate insomnia brings long-term pain to patients, and can cause fatigue, restlessness, general discomfort, listlessness, slow response, headache, and inability to concentrate. Schizophrenia and depression, anxiety, autonomic dysfunction and other functional diseases, as well as various system diseases, such as cardiovascular system, digestive system, etc. [0003] At present, the commonly used drugs for the treatment of insomnia include sedative-hypnotics (including barbiturates, benzodiazepines, a...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/32A61K47/26A61K47/38A61K31/4985A61P25/20
CPCA61K9/0056A61K9/2018A61K9/2054A61K9/2059A61K31/4985
Inventor 李辉刘杰罗红梅彭攸灵
Owner 湖南中医药高等专科学校
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