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Multilayer coating system enteric preparation for dexlansoprazole

A technology of dexlansoprazole and multi-layer coating, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, digestive system, etc., and can solve problems such as insufficient time for acid suppression.

Active Publication Date: 2014-08-06
SHANGHAI SUNTECH PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the enteric-coated preparations prepared by the conventional enteric-coating technology in the above-mentioned patents are still insufficient in terms of acid suppression time, and the challenge of patient compliance still exists

Method used

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  • Multilayer coating system enteric preparation for dexlansoprazole

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] 1. Drug layer Ⅰ:

[0046] The ratio of each substance is as follows:

[0047] components

%(w / w)

Weight (g)

Cane sugar core

50.00

300.0

Dexlansoprazole

30.00

180.0

hypromellose

5.00

30.0

meglumine

10.00

60.0

Sodium dodecyl sulfate

5.00

30.0

purified water

1200

[0048] The preparation steps are as follows:

[0049] 1) Dissolve hypromellose, meglumine and sodium lauryl sulfate in 1200g of purified water;

[0050] 2) Add dexlansoprazole to the above solution, stir and disperse evenly, and set aside;

[0051] 3) The mixed solution in step 2) is coated on the surface of the sucrose core with a GPCG2.0 fluidized bed to prepare the drug layer I. The temperature of the product during the preparation process is 35-37°C, and the ventilation volume is 1.2-1.4m 3 / min / kg, the spray speed is 10-12g / min / kg. After the preparation is completed, use a fluidized bed to...

Embodiment 2

[0102] Different isolation layer formulations have different water vapor permeability, and the isolation layer is prepared according to the following isolation layer formulation, and the water vapor permeability is tested with a W3 / 230 water vapor transmission rate tester.

[0103] The ratio of each material in the isolation layer is as follows:

[0104]

[0105] The preparation steps are as follows:

[0106] 1) Add sodium carboxymethyl cellulose to 3g of purified water and stir to dissolve;

[0107] 2) Add talcum powder to the remaining water and disperse evenly;

[0108] 3) Add the dispersion in step 2) to the solution in step 1), and stir to form a uniform suspension;

[0109] 4) Cut a 11cm square air-permeable membrane, fix the four corners, apply the suspension in step 3) on the air-permeable membrane, and dry while coating, and prepare a 50 mg / cm2 isolation layer after coating membrane.

[0110] 5) Use the W3 / 230 water vapor transmission rate tester to test the wa...

Embodiment 3

[0112] Prepare the isolation layer according to the following isolation layer prescription, and use the W3 / 230 water vapor transmission rate tester to test the water vapor permeability.

[0113] The ratio of each material in the isolation layer is as follows:

[0114]

[0115] The preparation steps are as follows:

[0116] 1) Add sodium carboxymethyl cellulose to 30g of purified water and stir to dissolve;

[0117] 2) Add talcum powder to the remaining water and disperse evenly;

[0118] 3) Add the dispersion in step 2) to the solution in step 1), and stir to form a uniform suspension;

[0119] 4) Cut a 11cm square air-permeable membrane, fix the four corners, apply the suspension in step 3) on the air-permeable membrane, and dry while coating, and prepare a 50 mg / cm2 isolation layer after coating membrane.

[0120] 5) Use the W3 / 230 water vapor transmission rate tester to test the water vapor transmission rate, and the measured result is 198 g / m2 / day.

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Abstract

The invention provides a novel multilayer coating system enteric preparation for dexlansoprazole. The preparation comprises a drug layer I, a drug layer II, enteric coating layers IV and isolating layers III, wherein the isolating layers III are arranged among the drug layer I or II and the enteric coating layers IV, the drug layer I and the drug layer II are respectively composed of dexlansoprazole, a filler, a binder, a stabilizing agent and a lubricant, and the preparation comprises, from interior to exterior, the drug layer I, the isolating layer III-1, the enteric coating layer IV-1, the isolating layer III-2, the drug layer II, the isolating layer III-3 and the enteric coating layer IV-2. The novel multilayer coating system enteric preparation for dexlansoprazole provided by the invention can improve the acid inhibition effect of dexlansoprazole and prolongs action time of dexlansoprazole, the isolation effect of the isolating layers in the whole preparation system is optimized, and stability of product quality is ensured; and a preparation method provided by the invention is applicable to industrial production and has a great application value.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a novel preparation of a proton pump inhibitor, in particular to an enteric-coated preparation of a multilayer coating system of the proton pump inhibitor D-lansoprazole released in multiple stages in the body. Background technique [0002] Proton pump inhibitors such as lansoprazole, which reduce gastric acid secretion through a specific targeted mechanism of action, are specific inhibitors of proton pumps in gastric parietal cells. For the treatment of gastroesophageal reflux disease, erosive reflux esophagitis, long-term maintenance therapy to prevent recurrence of cured patients with esophagitis, symptom control of gastroesophageal reflux disease, and for appropriate antimicrobial therapy combination It is used to eradicate Helicobacter pylori, and is used to heal duodenal ulcers associated with Helicobacter pylori infection, prevent recurrence of peptic ulcers associated with ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/00A61K31/4439A61K47/38A61P1/04
Inventor 何平钱晓明
Owner SHANGHAI SUNTECH PHARMA
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