Esomeprazole magnesium micro-tablet

A technology of esomeprazole magnesium and micro-tablets, which is applied in the field of medicine and can solve the problems of acid instability, poor patient compliance, and low bioavailability

Inactive Publication Date: 2013-01-02
NANJING ZENKOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Esomeprazole magnesium has poor solubility and is unstable to acid, so the bioavailability is not high, which affects the effect of drug administration and poor compliance for patients

Method used

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  • Esomeprazole magnesium micro-tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Esomeprazole Magnesium Microtablets

[0041] Drugs / Excipients

mg / tablet

Esomeprazole Magnesium

1.00

microcrystalline cellulose

6.00

colloidal silicon dioxide

0.04

Magnesium stearate

0.06

Methacrylic acid copolymer Eudragit L100

1.30

triethyl citrate

0.06

Glyceryl monostearate

0.13

Polysorbate 80

0.10

total

8.59

[0042] Preparation method: The drug is mixed with excipients and granulated with 50% W / W purified water. The dried granules are milled to obtain a particle size D50 of 100-300 microns and mixed with excipients and compressed into tablets. Enteric coating can be done by mixing methacrylic acid copolymer with suitable plasticizers, lubricants and surfactants and coating by Wuster type fluid bed coating or pan film coating.

[0043] The specific operation steps are as follows:

[0044] 1) Weigh 1.00 mg of esomeprazole magnesiu...

Embodiment 2

[0063] Esomeprazole Magnesium Microtablets

[0064] Drugs / Excipients

mg / tablet

Esomeprazole Magnesium

2.00

microcrystalline cellulose

6.00

colloidal silicon dioxide

0.10

Magnesium stearate

0.08

Methacrylic acid copolymer (Eudragit L100)

1.50

triethyl citrate

0.08

Glyceryl monostearate

0.15

Polysorbate 80

0.20

total

10.11

[0065] Preparation method: The drug is mixed with excipients and granulated with 50% W / W purified water. The dried granules are milled to obtain a particle size D50 of 100-300 microns and mixed with excipients and compressed into tablets. Enteric coating can be done by mixing methacrylic acid copolymer with suitable plasticizers, lubricants and surfactants and coating by Wuster type fluid bed coating or pan film coating.

[0066] The specific operation steps are as follows:

[0067] 1) Weigh 2.00 mg of esomeprazole magne...

Embodiment 3

[0086] Esomeprazole Magnesium Microtablets

[0087] Drugs / Excipients

mg / tablet

Esomeprazole Magnesium

4.00

microcrystalline cellulose

5.00

Colloidal silica

0.05

Magnesium stearate

0.05

Methacrylic acid copolymer (Eudragit L100)

1.00

triethyl citrate

0.05

Glyceryl monostearate

0.10

Polysorbate 80

0.10

total

10.35

[0088] Preparation method: The drug is mixed with excipients and granulated with 50% W / W purified water. The dried granules are milled to obtain a particle size D50 of 100-300 microns and mixed with excipients and compressed into tablets. Enteric coating can be done by mixing methacrylic acid copolymer with suitable plasticizers, lubricants and surfactants and coating by Wuster type fluid bed coating or pan film coating.

[0089] The specific operation steps are as follows:

[0090] 1) Weigh 4.00 mg of esomeprazole magnesium

[...

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Abstract

The invention discloses an esomeprazole magnesium micro-tablet, which is provided with a cylindrical space shape. The height of the esomeprazole magnesium micro-tablet is 1-3mm, and the diameter of the esomeprazole magnesium micro-tablet is 1-3mm. The content of the esomeprazole magnesium which is the active ingredient in the micro-tablet is 1-5mg, and the adopted enteric coating material is methacrylic acid copolymer (Eudragit L100). The enteric coating material of the esomeprazole magnesium micro-tablet also comprises triethyl citrate which is used as plasticizer, the content of the triethyl citrate is 0.05-0.08mg, glidant is glycerin monostearate, the content of the glycerin monostearate is 0.1-0.15mg, surfactant is polysorbate, and the content is 0.1-0.2mg. The micro-tablet and acceptable pharmaceutic adjuvants are prepared into the esomeprazole magnesium tablet, and the acceptable pharmaceutic adjuvants consist of lactose, croscarmellose sodium, polyvinylpyrrolidone and talcum powder. The esomeprazole magnesium micro-tablet disclosed by the invention can be used for treating the digestive tract ulcer disease.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a composition of esomeprazole magnesium micro-tablet and a preparation method thereof. Background technique [0002] With the development of our society, environmental changes, changes in population structure and people's lifestyle, the incidence of peptic ulcer mainly caused by smoking, drinking, emotional stress, drug stimulation and other factors has gradually increased, becoming a common and frequently-occurring disease. Bring great misery to the patient, cause the quality of life of the patient to decline. Based on the above reasons, the treatment of peptic ulcer has been paid more and more attention in clinical practice. Therefore, the development and production of safe and effective anti-peptic ulcer drugs has attracted attention, and has become one of the focus and hot spots of current drug research and development. [0003] Proton pump inhibitors (PPIs) are...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/32A61K31/4439A61K47/38A61P1/04
Inventor 祁艳徐卓业
Owner NANJING ZENKOM PHARMA
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