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Film-coated tablet of mosapride citrate and preparation method thereof

A mosapride citrate and film coating technology is applied in the field of pharmaceutical compositions containing mosapride citrate and its preparation, which can solve problems such as lowering productivity and affecting the appearance of film-coated tablets, and achieve Excellent stability and superior storage stability

Active Publication Date: 2018-04-06
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Usually, as a means of suppressing the increase of decomposition products, plasticizers are removed from the film coating components, however, this will lead to lower productivity during film coating and affect the final appearance of film coated tablets

Method used

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  • Film-coated tablet of mosapride citrate and preparation method thereof
  • Film-coated tablet of mosapride citrate and preparation method thereof
  • Film-coated tablet of mosapride citrate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0096] Embodiment 1 (sample 4)

[0097] [Table 7] Chip composition

[0098]

[0099] [Table 8] Composition of film coating aqueous solution

[0100]

[0101]

[0102] The plain tablet (core tablet) containing mosapride citrate was prepared according to the composition ratio shown in the above table [7].

[0103] 40g of purified water was added to the mixture containing mosapride citrate (5.29g), lactose (61.91g), starch (32.4g) and low-substituted hydroxypropyl cellulose (9.5g) for wet granulation, After drying, pass through a 30-mesh sieve to sieve and blend low-substituted hydroxypropylcellulose (9g), magnesium stearate (1.3g) and silicon dioxide (0.6g). Then the obtained granules are pressed into a plain tablet with a hardness of 3-10 kg using a punching film with a diameter of 6.5 mm.

[0104] The plain tablets (core tablets) obtained above were sprayed with the film coating solution having the ingredients shown in Table [8] to obtain film-coated tablets (about...

Embodiment 2

[0105] Embodiment 2 (sample 5)

[0106] [Table 9] Chip composition

[0107]

[0108] [Table 10] Composition of film coating aqueous solution

[0109]

[0110] The plain tablet (core tablet) containing mosapride citrate was prepared according to the composition ratio shown in the above table [9].

[0111] Add 40g of purified water to the mixture containing mosapride citrate (5.29g), lactose starch (92.81g) and low-substituted hydroxypropyl cellulose (14g) for wet granulation, and pass through a 30-mesh sieve after drying The granules were sized and blended with low-substituted hydroxypropylcellulose (6g) and magnesium stearate (1.9g). Then the obtained granules are pressed into a plain tablet with a hardness of 3-10 kg using a punching film with a diameter of 6.5 mm.

[0112] The plain tablets (core tablets) obtained above were sprayed with the film coating solution having the ingredients shown in Table [10] to obtain film-coated tablets (about 124 g per tablet).

Embodiment 3

[0113] Embodiment 3 (sample 6)

[0114] [Table 11] Chip composition

[0115]

[0116] [Table 12] Composition of film coating aqueous solution

[0117]

[0118] The plain tablet (core tablet) containing mosapride citrate was prepared according to the composition ratio shown in the above table [11].

[0119] Add 40g of purified water to the mixture containing mosapride citrate (5.29g), lactose (61.91g), mannitol (32.4g) and low-substituted hydroxypropyl cellulose (9.5g) for wet granulation After drying, pass through a 30-mesh sieve for sizing and blend low-substituted hydroxypropyl cellulose (9g), magnesium stearate (1.3g) and silicon dioxide (0.6g). Then the obtained granules are pressed into a plain tablet with a hardness of 3-10 kg using a punching film with a diameter of 6.5 mm.

[0120] The plain tablets (core tablets) obtained above were sprayed with the film coating solution having the ingredients shown in Table [12] to obtain film-coated tablets (about 124 g per...

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Abstract

The invention provides a pharmaceutical composition comprising active ingredient mosapride citrate and a preparation method thereof. Particularly, the pharmaceutical composition of mosapride citrate prepared herein meets the coating requirement, the dissolution of pharmaceutical composition of mosapride citrate in different media is improved, and the stability of the composition in the illumination stage is improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing mosapride citrate and a preparation method thereof. Background technique [0002] Mosapride citrate (Formula 1), chemical name (±)-4-amino-5-chloro-2-ethoxy-N-[[4-(4-fluorobenzyl)-2-morpholine Base] methyl] benzamide dihydrate citrate, a selective serotonin 4 (5-HT 4 ) receptor agonist, by stimulating 5-HT of cholinergic interneurons and myenteric plexuses in the gastrointestinal tract 4 receptors, promote the release of acetylcholine, thereby enhancing gastrointestinal motility, improving gastrointestinal symptoms in patients with functional dyspepsia, and does not affect the secretion of gastric acid. It is clinically used for functional dyspepsia with gastrointestinal symptoms such as heartburn, belching, nausea, vomiting, early satiety, and upper abdominal distension; it can also be used for gastroesophageal reflux disease, ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K31/5375A61K47/26A61K47/14A61K47/38A61K47/32A61P1/14A61P1/04A61P1/08A61P1/00
CPCA61K9/2054A61K9/2059A61K9/282A61K9/2826A61K9/2853A61K9/2866A61K31/5375
Inventor 董礼袁恒立孙运栋李辉黄玉超
Owner JIANGSU HANSOH PHARMA CO LTD
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