Pantoprazole and its sodium salt enteric sustained-release pellet preparation

A technology of pantoprazole and sustained-release pellets, which is applied in the field of pharmaceutical preparations to achieve the effects of beautiful appearance, large distribution area and good fluidity

Inactive Publication Date: 2009-05-13
ZHEJIANG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there are sustained-release tablets on the market in foreign countries. Recently, it has been reported that the US FDA has approved the dosage form of sustained-release suspension, but there is no report of the sustained-release dosage form of this drug in China.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Embodiment 1: the preparation of pantoprazole sustained-release pellets

[0040] Blank pellet core: 25-30 mesh sucrose blank pellet core

[0041] Sustained release layer coating: Eudragit RS: Eudragit RL=1:1

[0042] 5% EudragitRS, RL Alcohol in water, which also contains 1.25% magnesium stearate, 1.25% diethyl phthalate.

[0043] Isolation layer: 1% HPMC alcohol aqueous solution, which also has 1% propylene glycol, 1% talc.

[0044] Enteric layer: 15% EudragitL100-55 alcohol aqueous solution, which also contains 4% micropowder silica gel, 4% triethyl citrate

[0045] Preparation Process:

[0046] Weigh the blank ball core and put it in the fluidized bed, configure the pantoprazole alcohol aqueous solution, stir, and apply the medicine. A 50% weight gain of the pellets was made. Dry overnight at 40°C, perform the same operation, use acrylic resin to coat the slow-release film, increase its weight by 20%, dry at 40°C overnight, perform the same operation, use an app...

Embodiment 2

[0048] Blank pellet core: 25-30 mesh sucrose blank pellet core

[0049] Sustained release layer coating: Eudragit RS: Eudragit RL=1:4

[0050] 5% Eudragit RS, RL aqueous alcohol solution, which also contains 1.25% magnesium stearate, 1.25% diethyl phthalate. ,

[0051] Isolation layer: 1% HPMCL-50 alcohol aqueous solution, which also has 1% propylene glycol, 1% talc.

[0052] Enteric layer: 15% EudragitL100-55 alcohol aqueous solution, which also contains 4% micropowder silica gel, 4% triethyl citrate

[0053] Preparation Process:

[0054] Weigh the blank ball core and put it in the fluidized bed, configure the pantoprazole alcohol aqueous solution, stir, and apply the medicine. A 50% weight gain of the pellets was made. Dry overnight at 40°C, do the same thing, use acrylic resin to coat the slow-release film, make it increase in weight by 30%, dry at 40°C overnight, do the same thing, use an appropriate amount of 1% HPMC aqueous solution for outer coating, and use acryli...

Embodiment 3

[0056] Blank pellet core: 30-40 mesh microcrystalline cellulose blank pellet core

[0057] Sustained release layer coating: Eudragit RS: Eudragit RL=1:1

[0058] 5% EudragitRS, RL Alcohol in water, which also contains 1.25% magnesium stearate, 1.25% diethyl phthalate.

[0059] Isolation layer: 1% HPMC alcohol aqueous solution, which also has 1% propylene glycol, 1% talc.

[0060] Enteric layer: 15% EudragitL100-55 alcohol aqueous solution, which also contains 4% micropowder silica gel, 4% triethyl citrate

[0061] Preparation Process:

[0062] Weigh the blank ball core and put it in the fluidized bed, configure the pantoprazole alcohol aqueous solution, stir, and apply the medicine. A 40% weight gain of the pellets was made. Dry overnight at 40°C, perform the same operation, use acrylic resin to coat the slow-release film, increase its weight by 20%, dry at 40°C overnight, perform the same operation, coat the outer layer with an appropriate amount of 1% HPMC aqueous soluti...

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Abstract

The invention discloses pantoprazole and the sodium salt enteric sustained-release micropill preparation thereof. The preparation comprises pantoprazole-containing micropills, an isolation layer, a sustained-release layer, another isolation layer and an enteric layer from inside to outside in sequence; the weight of the first isolation layer is 0.5% to 40% of that of the pantoprazole-containing micropills, the weight of the sustained-release layer is 5% to 100% of that of the pantoprazole-containing micropills, the weight of the second isolation layer is 0.5% to 40% of that of the pantoprazole-containing micropills, and the weight of the enteric layer is 20% to 200% of that of the pantoprazole-containing micropills. The pantoprazole enteric sustained-release micropills can stably release the drug.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to pantoprazole and its sodium salt enteric-coated sustained-release pellet preparation. Background technique [0002] Digestive system diseases are one of the common frequently-occurring diseases, among which peptic ulcer is the main one. The incidence of gastrointestinal diseases is still increasing year by year, leading to the continuous expansion of the drug market for anti-digestive system diseases. The concept of "no acid, no ulcer" has been recognized for many years. Therefore, inhibiting gastric acid secretion is the main measure for treating peptic ulcer. At present, this type of drug has become one of the best-selling drugs in the world. [0003] PAZ-Na is a class of drugs with better effect on gastric acid secretion. It can irreversibly inhibit the H+ / K+-ATPase of gastric parietal cells, namely the proton pump, thereby inhibiting gastric acid secretion and tre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4439A61P1/04
Inventor 金一王远飞王成润
Owner ZHEJIANG UNIV
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