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Ilaprazole enteric-coated tablets and preparation method thereof

A technology of ilaprazole and ilaprazole calcium, which is applied in the direction of pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of poor reproducibility of enteric-coated effects, changes in drug release behavior of preparations, Affect the clinical efficacy and other issues, to achieve the effect of improving drug bioavailability, eliminating irritation, and releasing rapidly and stably

Inactive Publication Date: 2012-07-04
LIVZON PHARM GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Enteric-coated tablets are a single-dose drug, and the reproducibility of the enteric-coated effect is not good, which may easily cause intestinal irritation due to high local concentration, and errors or defects in the preparation of individual tablet products will lead to the drug release behavior of the overall preparation Changes that affect clinical efficacy

Method used

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  • Ilaprazole enteric-coated tablets and preparation method thereof
  • Ilaprazole enteric-coated tablets and preparation method thereof
  • Ilaprazole enteric-coated tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1: Preparation of pellets coated with ilaprazole sodium drug-loaded layer by centrifugal granulation

[0038] Table 1 Prescription of micropills containing ilaprazole sodium

[0039] material

amount (g)

Blank pellet core (0.2-0.3mm)

500

Ilaprazole Sodium

29

Potassium hydroxide

29

Polyvinylpyrrolidone (PVP K30)

50

water

[0040] Preparation of 5% (m / m) polyvinylpyrrolidone aqueous solution: weigh 50 g of PVP and dissolve in 25% (v / v) ethanol aqueous solution. Weigh 400 g of 5% (m / m) PVP solution, add the prescribed amount of sodium hydroxide, weigh ilaprazole sodium and dissolve it therein. Weigh 500 g of blank pellet cores (sucrose pellet cores) and pour them into the feed pot, turn on the host, adjust the host speed, air volume, jet pressure, and liquid spray rate, and spray the prepared drug-containing solution. After spraying the liquid medicine, continue to spray the blank P...

Embodiment 2

[0043] Example 2: Preparation of pellets coated with ilaprazole magnesium drug-loaded layer by centrifugal granulation

[0044] Table 3 Prescription of pellets containing ilaprazole magnesium

[0045] material

[0046] Processing of raw materials and auxiliary materials: Magnesium hydroxide and lactose are sieved through 100 meshes, and the prescription amount of micropowder silica gel is weighed and mixed with magnesium hydroxide, lactose and CMS-Na evenly for later use. Preparation of adhesive: preparation of 10% (m / m) PVP solution: weigh appropriate amount of PVP and dissolve in 95% (v / v) ethanol aqueous solution. Weigh the ilaprazole magnesium and magnesium hydroxide of prescription quantity, add in certain amount 10% (m / m) PVP solution, stir and dissolve. Weigh the prescribed amount of blank pellet cores (microcrystalline cellulose pellet cores) and pour them into the pot, turn on the host, adjust the host speed, air volume, jet pressure, and liquid spray rate,...

Embodiment 3

[0047] Example 3: Preparation of pellets coated with ilaprazole zinc drug-loaded layer by centrifugal granulation

[0048] Table 4 Prescription of pellets containing ilaprazole zinc

[0049] material

[0050] Processing of raw materials and auxiliary materials: sieve magnesia through 100 meshes, weigh the prescribed amount of sucrose and starch and mix evenly for later use. Preparation of adhesive: preparation of 1% HPMC solution: soak HPMC in hot water at 70° C. for 45 minutes, then stir evenly to prepare a 1% solution. Weigh the prescribed amount of ilaprazole zinc and magnesium oxide, add to a certain amount of 1% HPMC solution and stir to dissolve. Weigh the prescribed amount of blank pellet cores (microcrystalline cellulose pellet cores) and pour them into the pot, turn on the host, adjust the host speed, air volume, jet pressure, and liquid spray rate, and spray the prepared drug-containing solution. Pour the mixed excipient powder into the hopper. After the ...

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Abstract

The invention provides ilaprazole enteric-coated tablets and a preparation method thereof. Each enteric-coated tablet contains an enteric-coated pellet and pharmaceutically acceptable tablet excipients, wherein the enteric-coated pellet contains a pellet layer, a medicine loading layer, an isolation layer and an enteric coating layer; and the medicine loading layer contains ilaprazole or pharmaceutically acceptable salt thereof and a stabilizer. The enteric-coated pellet tablets prepared from the ilaprazole have good acid resistance; barrier substances such as an antiacid, a surfactant, an organic solvent, a hydrophobic substance and the like are not contained in the prescription, so that the enteric-coated pellet tablets have health benefits and are safe; the preparation method is easy to operate, the organic solvent is not used, and an active substance is quickly and stably released; and in addition, the pellets in the tablets can be widely and uniformly distributed in an intestinal tract after being taken, the dose dumping is dispersed, and the distribution area of a medicine on the surface of the intestinal tract is increased, so the irritation of the medicine to the intestinal tract can be reduced or eliminated, and the bioavailability of the medicine can be improved.

Description

technical field [0001] The invention relates to an enteric-coated tablet containing a proton pump inhibitor and a preparation method thereof, in particular to an enteric-coated tablet containing ilaprazole or a pharmaceutically acceptable salt thereof and a preparation method thereof. Background technique [0002] Ilaprazole is the latest generation of proton pump inhibitor developed by Ilyang Pharmaceutical Co., Ltd. and Livzon Pharmaceutical Co., Ltd. in Korea. It is widely used in various acid-related gastrointestinal diseases, such as duodenal Ulcers, gastric ulcers, reflux esophagitis, etc. Compared with other PPIs, ilaprazole has the strongest antacid activity, no individual differences in treatment, and stronger acid control ability at night, etc., and is expected to become the core product in the PPI market. [0003] Ilaprazole is not stable in acidic and neutral media, and is easily destroyed in gastric acid. Therefore, enteric-coated tablets are currently used dom...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4439A61K47/26A61K47/32A61K47/34A61K47/36A61K47/38A61K47/46A61P1/04
Inventor 侯雪梅金鑫陈乔柏张丽
Owner LIVZON PHARM GRP INC
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