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Method for producing freeze-dried preparation

A manufacturing method and drying technology, applied in freeze-drying conveying, powder conveying, inorganic inactive ingredients and other directions, can solve the problem of inaccurate content of active ingredients, and achieve the effect of accurate content of active ingredients

Inactive Publication Date: 2017-05-24
SAWAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this method, instead of buffering agent or aminocarboxylic acid chelating agent, piperacillin is used for pH adjustment, therefore, the final active ingredient content cannot be accurately

Method used

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  • Method for producing freeze-dried preparation
  • Method for producing freeze-dried preparation
  • Method for producing freeze-dried preparation

Examples

Experimental program
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Embodiment 1

[0063] Dissolve 2.4 kg of sodium hydroxide in 56.25L of water for injection, blow carbon dioxide into it, and adjust the pH to about 7.7. To the sodium hydroxide aqueous solution bubbled with carbon dioxide, the pH was slightly adjusted to 7.7 with 0.5 M hydrochloric acid aqueous solution, and while nitrogen was bubbled, 2.976 kg of trizobactam and 23.81 kg of piperacillin hydrate were added, and then further A 0.1M aqueous hydrochloric acid solution and water for injection were added to obtain 125L of an aqueous solution with pH 6.5. The prepared solution was sterilized by filtration and dispensed into sterile containers, and then freeze-dried according to a conventional method to obtain 0.25 g (titer) of tazobactam sodium and 2.0 g of piperacillin sodium in each container ( Titer), or 0.5 g of trizobactam sodium (titer), and 4.0 g (titer) of piperacillin sodium.

[0064] Hereinafter, the preparation of the present invention containing 0.25 g of tazobactam sodium (titer) and 2....

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Abstract

The present invention addresses the main problem of providing a novel method for producing a freeze-dried preparation (combination drug) for injection that comprises tazobactam sodium and piperacillin sodium. An example of the production method according to the present invention is as follows. A method for producing a freeze-dried preparation for injection, said method being characterized by comprising: (a) a step for blowing carbon dioxide gas into an aqueous sodium hydroxide solution; and (b) a step for dissolving tazobactam and piperacillin in the solution obtained in step (a). According to the present invention, a freeze-dried preparation showing good defoaming performance after redissolution can be obtained.

Description

Technical field [0001] The invention relates to a new manufacturing method of a freeze-dried preparation for injection containing Tazobactam Sodium and Piperacillin Sodium. Background technique [0002] The combination of Tazobactam and Piperacillin is widely used worldwide under the trade name "Zosyn" (registered trademark) in the form of a freeze-dried preparation for intravenous injection. [0003] In order to manufacture a freeze-dried preparation for injection containing the tazobactam and piperacillin, it is necessary to react the free forms of tazobactam and piperacillin with sodium ions in the solution before freeze-drying to produce tazobactam And the respective sodium salts of piperacillin. However, both trizobactam and piperacillin have low stability in alkaline solutions, and strong alkalis such as sodium hydroxide solutions used for pH adjustment or sodiumization in the manufacture of injections cannot be used. [0004] In order to solve the above-mentioned problems, i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K9/19A61K47/02A61P31/04
CPCA61K9/19A61K31/43A61K47/02
Inventor 春名诚司尾留川大贵
Owner SAWAI PHARMA
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