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Oral quick-release membrane containing mosapride citrate solid dispersion

A technology of mosapride citrate and solid dispersion, applied in the field of preparation, can solve the problems of low bioavailability, poor patient compliance, frequent administration, etc., achieve rapid drug release, improve patient compliance, and mask drugs Effects of bad taste

Inactive Publication Date: 2019-05-03
重庆健能医药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Mosapride citrate is affected by the first-pass effect of the liver, and its bioavailability is low. However, conventional clinical oral dosage forms such as capsules and tablets all have the problems of frequent administration and poor patient compliance.

Method used

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  • Oral quick-release membrane containing mosapride citrate solid dispersion
  • Oral quick-release membrane containing mosapride citrate solid dispersion
  • Oral quick-release membrane containing mosapride citrate solid dispersion

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Embodiment 1

[0029] Embodiment 1: Preparation of oral immediate-release film containing mosapride citrate solid dispersion Prepare 100 tablets, each containing 5 mg of mosapride citrate, the amount of raw materials and auxiliary materials is: mosapride citrate Puridine 0.5g, hydroxypropylcellulose 1.8g, hydroxypropylmethylcellulose 4.0g, methylcellulose 1.3g, carbomer 0.1g, PEG400: 1.9g, sodium saccharin 0.1g.

[0030] The preparation method steps are as follows:

[0031] (1) Preparation of mosapride citrate solid dispersion: take mosapride citrate and hydroxypropyl cellulose and place them in a mixing agitator, add methanol, stir evenly to dissolve them; use a spray drier to dissolve the solution Prepare a solid dispersion, and finally get a mosapride citrate-hydroxypropyl cellulose solid dispersion;

[0032] (2) Preparation of an oral immediate-release film comprising mosapride citrate solid dispersion:

[0033] Disperse the hydroxypropyl methylcellulose evenly with an appropriate amou...

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Abstract

The invention discloses an oral quick-release membrane containing mosapride citrate solid dispersion. The membrane is prepared from the following raw material medicines and auxiliary materials in parts by weight: 3.0-8.0 parts of mosapride citrate, 10.0-20.0 parts of hydroxypropyl cellulose, 20.0-44.0 parts of hydroxypropyl methyl cellulose, 10.0-15.0 parts of methyl cellulose, 0.5-1.0 parts of carbomer, 9.0-28.0 parts of a plasticizer, and 1.0-4.0 parts of sodium saccharin. The oral quick-release membrane containing mosapride citrate solid dispersion of the invention can be conveniently applied to patients with dysphagia, the medicine release is rapid, the bioavailability and patient compliance are improved, the medicines exist in a preparation in an amorphous form, the shelf life of themedicines can be prolonged, and the effect of masking the bad taste of the medicines is realized.

Description

technical field [0001] The invention relates to a preparation, in particular to an oral immediate-release film containing mosapride citrate solid dispersion. Background technique [0002] Mosapride Citrate (Mosapride Citrate), the chemical name is 4-amino-5-chloro-2-ethoxy-N-[[4-(4-fluorobenzyl)-2-morpholinyl]methanol base] benzamide citrate. Mosapride citrate is white or off-white crystalline powder, odorless, slightly bitter. The melting point is 143-145°C. It is easily soluble in dimethylformamide and pyridine, slightly soluble in methanol, hardly soluble in 95% ethanol, insoluble in water or ether. [0003] Mosapride citrate is a new third-generation gastric motility drug, mainly used for functional dyspepsia with heartburn, belching, nausea, vomiting, early satiety, upper abdominal distension and other gastrointestinal symptoms. The drug can enhance gastrointestinal motility, but does not affect gastric acid secretion, and has no side effects such as extrapyramidal ...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K47/38A61K31/5375A61P1/14
Inventor 王祖焕王鹏飞李于林
Owner 重庆健能医药开发有限公司
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