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Esomeprazole enteric-coated tablets and preparation method thereof

An enteric and tablet-dissolving technology for esomeprazole, which is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery, and can solve problems such as the inability of coated pellets to withstand pressure.

Active Publication Date: 2014-05-14
北京华禧联合科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The cited reference Drugs Made In Germany also states that the use of copolymer L30D-55 without the addition of copolymer NE30D as enteric coating layer material will result in coated pellets not being able to withstand the pressure applied during tableting

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Drug loading layer coating:

[0012] Esomeprazole Magnesium 500g

[0013] Sugar ball core 300g

[0014] Hypromellose 45g

[0015] 1000 grams of purified water

[0016] Isolation layer coating:

[0017] Drug-loaded layer pellets 500g

[0018] Opadry 100g

[0019] 1000 grams of purified water

[0020] Enteric layer coating:

[0021] Isolation layer pellets 500g

[0022] Methacrylic acid copolymer 400 g

[0023] Triethyl citrate 60g

[0024] Purified water 1800g

[0025] Tableting:

[0026] Enteric-coated pellets 200g

[0027] Microcrystalline cellulose 400 g

[0028] 200g lactose

[0029] Micronized silica gel 8g

[0030] The microcrystalline cellulose and lactose are mixed uniformly and then dry granulated. The obtained particles are sieved. The particles above 30 mesh are defined as material 1, particles below 30 mesh and above 60 mesh are defined as material 2, and those below 60 mesh are defined as material 3. . Mix material 1, material 2, material 3 and enteric layer pellets in a ratio of...

Embodiment 2

[0032] Drug loading layer coating:

[0033] Esomeprazole Magnesium 500g

[0034] Sugar ball core 500g

[0035] Hypromellose E15 50g

[0036] 1000 grams of purified water

[0037] Isolation layer coating:

[0038] Drug-loaded layer pellets 500g

[0039] Hypromellose E15 40g

[0040] Talc 60g

[0041] 1000 grams of purified water

[0042] Enteric layer coating:

[0043] Isolation layer pellets 500g

[0044] Yakyi 400g

[0045] 2000 grams of purified water

[0046] Tableting:

[0047] Enteric-coated pellets 200g

[0048] Mannitol 300g

[0049] 300g lactose

[0050] Micronized silica gel 6 grams

[0051] The mannitol and lactose are mixed uniformly and then dry granulated. The obtained particles are sieved. The particles of 30 mesh or more are defined as material 1, the particles below 30 mesh and 60 mesh or more are defined as material 2, and the particles below 60 mesh are defined as material 3. Mix material 1, material 2, material 3 and enteric layer pellets in a ratio of 1:1:1:1, mix them with finel...

Embodiment 3

[0053] Drug loading layer coating:

[0054] Esomeprazole Magnesium 500g

[0055] Sugar ball core 500g

[0056] Hypromellose E15 50g

[0057] 1000 grams of purified water

[0058] Isolation layer coating:

[0059] Drug-loaded layer pellets 500g

[0060] Opadry 120g

[0061] 1000 grams of purified water

[0062] Enteric layer coating:

[0063] Isolation layer pellets 500g

[0064] Jacques 500g

[0065] Purified water 2500g

[0066] Tableting:

[0067] Enteric-coated pellets 200g

[0068] Microcrystalline cellulose 300g

[0069] 300g lactose

[0070] Magnesium stearate 8g

[0071] The microcrystalline cellulose and lactose are mixed uniformly and then dry granulated. The obtained particles are sieved. The particles above 30 mesh are defined as material 1, particles below 30 mesh and above 60 mesh are defined as material 2, and those below 60 mesh are defined as material 3. . The material 1, material 2, material 3 and enteric-coated layer pellets are mixed in a ratio of 1:0.5:1.5:1, mixed with magnesi...

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PUM

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Abstract

The invention discloses esomeprazole enteric-coated tablets and a preparation method thereof. The formula of the tables comprises esomeprazole magnesium, and an inert pellet core, a binder, a dispersant and a disintegrant which are used for tablet preparation. The preparation method comprises spraying and coating esomeprazole magnesium on the blank pellet core, coating an isolating layer and an enteric coated layer, making into enteric-coated pellets, and making into the required enteric-coated preparation by using the specific tablet adjuvants and tabletting method. The esomeprazole enteric-coated tablets and the preparation method thereof disclosed by the invention have the characteristics that by adopting specific tablet preparation method, the shortcoming that the enteric coated layers of the enteric-coated pellets are easy to be broken during tabletting process to affect the acid resistance of esomeprazole enteric-coated tablets is effectively overcome.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and specifically relates to an esomeprazole enteric-coated tablet and a preparation method thereof. The esomeprazole enteric-coated tablet is taken orally, wherein the esomeprazole is loaded by a plurality of pellets, and the pellets are loaded with esomeprazole and then wrapped with an isolation layer and an enteric layer. In addition, the present invention also designs a preparation method of the preparation. The preparation method can improve the pressure resistance of the pellets during the tableting process and avoid the enteric coating layer from being damaged. Background technique [0002] Gastroesophageal reflux disease (GERD)-treatment of erosive reflux esophagitis-long-term maintenance treatment for patients with cured esophagitis to prevent recurrence-control of symptoms of gastroesophageal reflux disease (GERD) and appropriate antibacterial therapy The combination medication era...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/36A61K31/4439A61P1/04
Inventor 梁屹刘燕平毕华
Owner 北京华禧联合科技发展有限公司
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