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Naproxen and esomeprazole magnesium compound enteric coated tablets and preparation method thereof

A technology for esomeprazole magnesium and naproxen intestines is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc. The preparation process is easy and the effect of improving stability

Inactive Publication Date: 2017-05-03
SHANGHAI SUNTECH PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For the existing marketed varieties, the drug loading of esomeprazole magnesium is completed through the tablet coating process, which is difficult to achieve and requires high technology

Method used

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  • Naproxen and esomeprazole magnesium compound enteric coated tablets and preparation method thereof
  • Naproxen and esomeprazole magnesium compound enteric coated tablets and preparation method thereof
  • Naproxen and esomeprazole magnesium compound enteric coated tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Example 1: Naproxen Esomeprazole Magnesium Enteric-Coated Tablets

[0067]

[0068]

[0069] Preparation:

[0070] (1) Dissolve 650g of hypromellose (E5) in 13,600g of purified water, slowly add 3,750g of naproxen raw material (D90<10 microns) micronized by jet mill (model H100) under stirring, and continue stirring to prepare drug suspension;

[0071] (2) Take 900g of microcrystalline cellulose pellet core (0.1-0.2mm) and place it in a fluidized bed (model FLZB-10), preheat until the product temperature is 35°C±2°C, spray into step (1) to apply the drug Suspension, adjust fluidized bed inlet air temperature (45-55°C), inlet air volume (300-800m 3 / h), spray speed (5-100g / min) and atomization pressure (1-3bar), so that the product temperature is 35±2°C, and the pellets are in a fluidized state, no adhesion, no spray drying, until After spraying the drug suspension, keep the product temperature and continue to dry for 30 minutes, so that the water content of the...

Embodiment 2

[0085] Example 2: Naproxen Esomeprazole Magnesium Enteric-Coated Tablets

[0086]

[0087]

[0088] Preparation:

[0089] (1) Dissolve 866.7 g of hypromellose (E5) in 18,133 g of purified water, slowly add 5,000 g of naproxen raw material (D90<10 microns) micronized by a jet mill (model H100) under stirring, and continue stirring to prepare into a drug suspension;

[0090] (2) Take 1200g of microcrystalline cellulose pellet core (0.1-0.2mm) and place it in a fluidized bed, preheat until the product temperature is 45°C±2°C, spray the drug suspension in step (1), and adjust the fluidization Bed inlet air temperature (55-65℃), inlet air volume (300-900m3 / h), liquid spray speed (5-100g / min) and atomization pressure (1-3bar), so that the product temperature is 45±2℃ , and make the pellets in a fluidized state, non-adhesive, not spray-dried, until the drug suspension is sprayed, maintain the product temperature, and continue to dry for 10 minutes, so that the moisture conten...

Embodiment 3

[0104] Example 3: Naproxen and Esomeprazole Magnesium Compound Enteric-coated Tablets

[0105]

[0106] Preparation:

[0107] (1) Dissolve 650g of hypromellose (E5) in 13,600g of purified water, slowly add 3,750g of naproxen raw material (D90<10 microns) micronized by jet mill (model H100) under stirring, and continue stirring to prepare drug suspension;

[0108] (2) Take 900g of microcrystalline cellulose pellet core (0.1-0.2mm) and place it in a fluidized bed, preheat it until the product temperature is 35-45°C, spray the drug suspension in step (1), and adjust the fluidized bed Inlet air temperature (45-55°C), air intake volume (300-900m 3 / h), spray speed (5-100g / min) and atomization pressure (1-3bar), so that the product temperature is 35-45°C, and the pellets are in a fluidized state, no adhesion, no spray drying, until After the drug suspension is sprayed, continue to dry for 30 minutes, so that the water content of the pellets is <1.5%, and the drug-containing pe...

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Abstract

The invention provides naproxen and esomeprazole magnesium compound enteric coated tablets, which are composed of an active component and a pharmaceutical adjuvant. The active component comprises (1) naproxen enteric pellets and (2) esomeprazole magnesium quick-release particles. Each tablet comprises 375-500 mg of naproxen and 20 mg of esomeprazole magnesium based on esomeprazole per single dosage. The releasing degree of the compound enteric coated tablets is measured, and the result shows that the releasing degree is more than 80%, and reaches 85-90%. In an acceleration condition, compared with enteric coated tablets placed for zero month, enteric coated tablets placed for three months have no obvious change in property, releasing degree, content, and related substances and are stable in quality. According to a preparation method of the naproxen and esomeprazole magnesium compound enteric coated tablets, the content of esomeprazole magnesium is easy to control, and the size of prepared naproxen enteric pellets is close to that of the esomeprazole magnesium quick-release particles, so that the naproxen enteric pellets and esomeprazole magnesium quick-release particles are easy to be uniformly mixed. The content uniformity of pressed tablets meets requirements, and the preparation method is suitable for massive industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a compound pharmaceutical preparation, in particular to a compound enteric-coated tablet of naproxen and esomeprazole magnesium and a preparation method thereof. Background technique [0002] Naproxen is a non-steroidal anti-inflammatory analgesic, the English name is Naproxen, and its chemical formula is C 14 h 14 o 3 , the molecular weight is 230.259. It has a wide range of clinical applications and is suitable for the treatment of fever, inflammation, swelling and pain caused by various reasons. However, it has obvious gastrointestinal side effects. After the drug enters the stomach, it will cause certain damage to the gastric mucosa. In severe cases, it can lead to peptic ulcer, bleeding, and perforation. [0003] Esomeprazole magnesium is the S-isomer of omeprazole, and its trihydrate is generally used clinically. The English name is Esomeprazole magnesium trihydrate, and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/22A61K31/4439A61P19/02A61P29/00A61K31/192
Inventor 刘学军顾宙辉牛国琴
Owner SHANGHAI SUNTECH PHARMA
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