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Liquid preparation containing Vonoprazan

A liquid preparation, the technology of vonoprazan fumarate, which is applied in the field of medicine, can solve the problems that the drug effect is not as obvious as the injection, and can not achieve good results, so as to achieve easy access to excipients, improved stability, stable and reliable process control effect

Inactive Publication Date: 2016-06-08
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Since the Vonorazan Fumarate Tablets developed and marketed by Takeda Corporation of Japan are routinely administered orally, the rapidity of the drug effect is not as obvious as that of injections. When dealing with some acute diseases, such as gastric ulcers caused by postoperative stress , duodenal ulcer, anastomotic ulcer, oral medication cannot achieve good results

Method used

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  • Liquid preparation containing Vonoprazan
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  • Liquid preparation containing Vonoprazan

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment one (anti-metal ion complexation-pH investigation)

[0021] prescription

[0022] Name of raw material

[0023] Prepare injections according to the above prescriptions, and investigate the anti-metal ion activity at different pHs. ), prescription 5 (pH8.0).

[0024] craft

[0025] The processes of prescription 1 to prescription 5 are all the same, only the difference in pH, the specific process is as follows:

[0026] Weigh the vinoprazan fumarate in a glass beaker, add water for injection, and stir the mixture with a stirrer to dissolve them. Add 1 mol / L sodium hydroxide aqueous solution, and adjust the mixture to the corresponding value of the prescription.

[0027] This experiment investigated the content precipitation of vinoprazan fumarate injection after 30 days storage.

[0028] prescription name

[0029] From the above results, it can be seen that the anti-metal ion activity of the preparations at pH 7.0 and pH 8.0 is higher t...

Embodiment 2

[0030] Embodiment two (anti-metal ion complexation-EDTA-Na dosage investigation)

[0031] prescription

[0032] Name of raw material

[0033] The process of prescription 6 to prescription 7 is the same, only the amount of EDTA-Na is different, the specific process is as follows:

[0034] Weigh vinorazan fumarate and EDTA-Na in a glass beaker, add water for injection, and stir the mixture with a stirrer to dissolve them. A 1 mol / L aqueous sodium hydroxide solution was added to adjust the mixture to 7.0.

[0035] This experiment investigated the content precipitation of vinoprazan fumarate injection after 30 days storage.

[0036] prescription name

[0037] As can be seen from the above results, when the pH was 7.0, the EDTA-Na dosage only needed 5 mg (0.1% w / v) to satisfy the anti-metal ion complexation, so the present invention adopts EDTA-Na dosage as 0.1% w / v.

Embodiment 3

[0038] Embodiment three (stabilizer-inorganic salt dosage investigation)

[0039] prescription

[0040]

[0041] Weigh vinorazan fumarate, EDTA-Na, and halides in a glass beaker, add water for injection, and stir the mixture with a stirrer to dissolve them. A 1 mol / L aqueous sodium hydroxide solution was added to adjust the mixture to 7.0.

[0042] This experiment investigated the changes of related substances in vinoprazan fumarate injection placed at 60°C for 30 days.

[0043]

[0044] As can be seen from the above results, the use of sodium bromide and sodium chloride has no significant impact on the stability of the preparation, and the amount of sodium chloride has a significant impact on the stability. When the amount of sodium chloride is 9mg (0.18%), good stability can be achieved. Effect, so the present invention adopts sodium chloride consumption to be 0.18%w / v.

[0045]The Wonorazan liquid preparation of the present invention, by investigating the high-temp...

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Abstract

The invention provides a liquid preparation containing Vonoprazan, relates to the field of medicines and in particular to a preparation method and stability study of multiple liquid preparations containing the Vonoprazan. The liquid preparation further contains a pH regulator, a metal ion complexing agent and inorganic salt except the active ingredient Vonoprazan. The relatively stable liquid preparation products are determined by studying the Vonoprazan liquid preparations prepared by adopting different prescriptions and processes.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a preparation method of various liquid preparations containing vonorazan, and its stability is investigated. technical background [0002] Vonoprazan fumarate is a potassium ion competitive acid blocker (P-CAB) developed by Japan's Takeda Corporation (Takeda). The in vitro activity test shows that the ability of the compound to inhibit the proton pump is superior to that of lansoprazole. 400 times, its selectivity to Na+, K+-ATPase is more than 500 times. In cultured rabbit gastric gland tissue, TAK-438 showed higher enrichment rate and slower clearance rate than lansoprazole, which made it have stronger potency and longer-lasting acid-suppressing effect in vivo. [0003] Vonoprazan fumarate has excellent gastric acid secretion inhibitory effect (especially proton pump inhibitory effect). Unlike conventional proton pump inhibitors (such as omeprazole, lansoprazole, etc., which form cova...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/19A61K31/4439A61K47/18A61K47/04A61P1/04
CPCA61K9/0019A61K9/08A61K9/19A61K31/4439A61K47/02A61K47/183
Inventor 陈勇曹焱
Owner FUKANGREN BIO PHARMA
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