Enteric-coated tablet containing pantoprazole and preparation method thereof

A technology of pantoprazole and enteric-coated tablets, which is applied in the field of enteric-coated tablets containing pantoprazole and its preparation, can solve the problems of poor stability, cumbersome preparation process, decreased acid resistance and release rate, and achieve Ease of industrial production, simple production process, and improved stability

Active Publication Date: 2015-07-08
LIAONING NIRVANA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Due to the poor stability of pantoprazole, the enteric-coated tablets prepared by the existing formulation technology all need to be stored in a cool condition (less than 20°C). Improper storage conditions will cause discoloration in appearance, decrease in acid resistance and release rate, decrease in content, and increase in related substances within the validity period, which will affect the safety and effectiveness of the drug.
At the same time, the preparation of existing pantoprazole enteric-coated tablets mostly adopts the technology of wet granulation and then tablet coating, the formula composition is complicated, and the preparation process is loaded down with trivial details, which is unfavorable for industrialized production

Method used

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  • Enteric-coated tablet containing pantoprazole and preparation method thereof
  • Enteric-coated tablet containing pantoprazole and preparation method thereof
  • Enteric-coated tablet containing pantoprazole and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A kind of enteric-coated tablet containing pantoprazole

[0022] S11. Weigh 40 parts of pantoprazole; 20 parts of sodium carbonate; 1 part of sodium citrate; 0.1 part of vitamin E; 20 parts of filler, 1 part of lubricant; 5 parts of xylitol;

[0023] S12. Dissolve the sodium carbonate and sodium citrate weighed in step S11 in purified water and set aside

[0024] S13, dissolving the pantoprazole and vitamin E weighed in step S11 in absolute ethanol for subsequent use;

[0025] S14. Disperse the solution prepared in step S12 in the solution prepared in step S13 under stirring conditions, dry the mixed solution under reduced pressure, pulverize and sieve to obtain pantoprazole complex powder;

[0026] S15. Mix the powder obtained in step S14 with an appropriate amount of xylitol, a filler and a lubricant, and then directly compress the tablet to obtain a tablet core;

[0027] S16. Using hydroxypropyl methylcellulose as a film-forming material, polyethylene glycol as a p...

Embodiment 2

[0030] S21. Weigh 40 parts of pantoprazole sodium; 80 parts of sodium carbonate; 10 parts of sodium citrate; 1 part of vitamin E; 40 parts of filler, 5 parts of lubricant; 10 parts of xylitol;

[0031] S22. Dissolve the sodium carbonate and sodium citrate weighed in step S21 with purified water and set aside

[0032] S23, dissolving the pantoprazole and vitamin E weighed in step S21 in absolute ethanol for subsequent use;

[0033] S24. Disperse the solution prepared in step S22 in the solution prepared in step S23 under stirring conditions, dry the mixed solution under reduced pressure, pulverize and sieve to obtain pantoprazole complex powder;

[0034] S25, mixing the powder obtained in step S24 with an appropriate amount of xylitol, a filler and a lubricant, and then directly compressing the tablet to obtain a tablet core;

[0035] S26, using hydroxypropyl methylcellulose as film-forming material, polyethylene glycol as plasticizer, talcum powder as anti-adhesive agent, wat...

Embodiment 3

[0038] S31. Weigh 40 parts of pantoprazole; 50 parts of sodium carbonate; 5.5 parts of sodium citrate; 0.55 parts of vitamin E; 30 parts of filler, 3 parts of lubricant; 7.5 parts of xylitol;

[0039] S32, dissolving the sodium carbonate and sodium citrate weighed in step S31 with purified water, and set aside

[0040] S33, dissolving the pantoprazole and vitamin E weighed in step S31 in absolute ethanol for subsequent use;

[0041] S34. Disperse the solution prepared in step S32 in the solution prepared in step S33 under stirring conditions, dry the mixed solution under reduced pressure, pulverize and sieve to obtain pantoprazole complex powder;

[0042] S35, mixing the powder obtained in step S34 with an appropriate amount of xylitol, a filler and a lubricant, and then directly compressing into tablets to obtain tablet cores;

[0043] S36. Using hydroxypropyl methylcellulose as a film-forming material, polyethylene glycol as a plasticizer, talcum powder as an anti-adhesive ...

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Abstract

The invention discloses an enteric-coated tablet containing pantoprazole and a preparation method thereof. The enteric-coated tablet is prepared by wrapping a tablet core successively by an isolation coating and an enteric coating. The tablet core is prepared from following raw and auxiliary materials, by weight: 40 parts of the pantoprazole or a sodium salt thereof, 20-80 parts of sodium carbonate, 1-10 parts of sodium citrate, 0.1-1 part of vitamin E, 5-10 parts of xylitol, 20-40 parts of a filling agent and 1-5 parts of a lubricant. The enteric-coated tablet is quickly-released in intestinal juice, is higher than 90% in release rate after 30 min, is significantly improved in stability, and can be stored for 6 months at 40 DEG C under the humidity of 75% without different change in various quality indexes when compared with the quality indexes of a tablet just has been prepared. Meanwhile, the preparation method and the formula composition of the enteric-coated tablet are simple, so that industrial production of the tablet is easy to carry out.

Description

technical field [0001] The invention relates to the field of pharmaceutical formulations, in particular to an enteric-coated tablet containing pantoprazole and a preparation method thereof. Background technique [0002] Pantoprazole is a new generation of proton pump inhibitors following omeprazole and lansoprazole. Its main pharmacological effect is to inhibit gastric acid secretion through the H+ / K+-ATPase of gastric parietal cells. It mainly treats duodenal ulcer, Gastric ulcers, Zoe-Elser syndrome, and reflux esophagitis. Pantoprazole is one of several common proton pump inhibitors (PPI) on the market at present, according to literature reports, the bioavailability of pantoprazole is 7 times higher than omeprazole, and the selectivity to parietal cells is more dedicated. Pantoprazole is a dialkoxypyridylbenzimidazole compound with good target specificity and acid stability, and daily oral standard dose (40mg) of pantoprazole can inhibit 98% of gastric acid secreted, f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/4439A61K47/26A61K47/38A61P1/04
Inventor 王瑞杰魏兆龙张国峰李春茹杨学富沈桂丹邱卫华张晓燕杜世坤
Owner LIAONING NIRVANA PHARMA
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