Enteric-coated micropellet containing esomeprazole magnesium
A technology of esomeprazole magnesium and enteric-coated pellets, which is applied to medical preparations containing active ingredients, medical preparations without active ingredients, organic active ingredients, etc. Unable to maintain and other problems, to achieve the effect of uniform distribution of pellets and effective and uniform film coating
Active Publication Date: 2015-03-18
SICHUAN GOWELL PHARMA
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Problems solved by technology
Some of the methods disclosed in the prior art, such as the method disclosed in the above-mentioned Chinese patent application CN103127026A, can achieve a loss of less than 10% in the acid for 2 hours in long-term placement, and a release rate higher than 75% in the buffer for 30 minutes, and Esomeprazole magnesium enteric-coated pellets with a total impurity content of less than 2%, but because its acid resistance, release rate and other indicators are far lower than the measured values of the original research product, its onset time and clinical efficacy are different from those of the original research product. Compared with listed products, there is still a certain gap
However, the prescription of the original product on the market is only suitable for smaller pellet cores (0.1mm to 0.3mm). Compared with large pellet cores, the liquid droplets of small pellet cores are not easy to spread during coating spraying, which may easily lead to pill adhesion, making production difficult; at the same time , the specific surface area of the small pellet core is large, and it is easy to cause problems such as large amount of coating material and high production cost.
[0010] In view of the fact that it is difficult for the existing techn...
Method used
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Examples
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Embodiment 1
[0096]
[0097] In this example, the inert pellet core is a sucrose-type pellet core purchased from Hangzhou Gaocheng Bio-Nutrition Technology Co., Ltd.
Embodiment 2
[0099]
[0100] In this example, the inert pellet core is a microcrystalline cellulose pellet core purchased from Haining Weijing Pharmaceutical Excipient Technology Development Co., Ltd.
Embodiment 3
[0102]
[0103] In this example, the inert pellet core is a starch-type pellet core made by a centrifugal coating granulator.
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Abstract
The invention relates to an enteric-coated micropellet containing esomeprazole magnesium. The enteric-coated micropellet comprises an inert pellet core, a medicament-loaded layer, an isolation layer and an enteric-coated layer, wherein the enteric-coated layer contains a methacrylic acid/ethyl acrylate 1: 1 copolymer, glyceryl monostearate, Tween 80 and talcum powder, wherein the methacrylic acid/ethyl acrylate 1: 1 copolymer is preferably Eudragit L30D-55. The enteric-coated micropellet containing esomeprazole magnesium, provided by the invention, can give consideration to acid resistance, release rate and stability of a product for a long time in the placement process, can meet or exceed existing preparation quality standards; and furthermore, the enteric-coated micropellet is prepared by simple process steps, is suitable for a relatively large pellet core (0.3mm-1mm), has the characteristic of low production cost, and is more suitable for large-scale industrialized production.
Description
technical field [0001] The invention relates to pharmaceutical preparations, in particular to an enteric-coated pellet containing esomeprazole magnesium. Background technique [0002] Esomeprazole (Esomeprazole, 5-methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl-1H -benzimidazole) is a new generation of proton pump inhibitors (PPIs) that inhibit H + / K + -ATPase to reduce gastric acid secretion and prevent the formation of gastric acid. Esomeprazole is the L-isomer of the first generation PPI omeprazole. The effect is better, there is no obvious acid breakthrough phenomenon at night, 24 hours of continuous acid suppression, less individual differences, less interaction with other drugs and other advantages, it is the current treatment of acid-related diseases, such as peptic ulcer, gastroesophageal reflux disease , Zollinger-Ellison syndrome and other drugs of choice. [0003] The original manufacturer of esomeprazole magnesium salt is AstraZeneca, a Br...
Claims
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IPC IPC(8): A61K9/16A61K31/4439A61K47/12A61K47/32A61K47/14A61K47/26A61K47/04A61P1/04
Inventor 汪飞郭礼新郭晖
Owner SICHUAN GOWELL PHARMA
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