Process for the preparation of lyophilized piperacilline sodium with improved stability after reconstitution

A technology for drying piperacillin sodium and piperacillin is applied in the field of preparing freeze-dried piperacillin sodium, and can solve problems such as danger, serious patient and the like

Active Publication Date: 2008-11-05
SANDOZ LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Without treatment, these microorganisms can multiply and grow unhindered, with serious and dangerous consequences for patients

Method used

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  • Process for the preparation of lyophilized piperacilline sodium with improved stability after reconstitution
  • Process for the preparation of lyophilized piperacilline sodium with improved stability after reconstitution
  • Process for the preparation of lyophilized piperacilline sodium with improved stability after reconstitution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0146] Into a 1 L stirred reactor was charged 109 mL of water, 60.00 g of piperacillin monohydrate (equivalent to 58.00 g of anhydrous acid; 11.2 cMol) and 7.25 g (2.4 cMol) of tazobactam (piperacillin with tazoba Tan ratio is 8:1). With good stirring, 11.43 g of sodium bicarbonate (13.6 cMol) were added in portions over 1 hour. Stirring was continued for 30 minutes while applying a vacuum of 20-30 mBar absolute. Determination of CO 2 Less than 75 mg / L (if higher, continue stirring under vacuum for another 30 minutes), adjust pH to 5.5-7.0 by adding piperacillin monohydrate (PIP) or sodium bicarbonate (BIC) if necessary. The solution was then lyophilized.

[0147] initial pH

Embodiment 2

[0149] To a 1 L stirred reactor was added 109 mL of water and 11.43 g of sodium bicarbonate (13.6 cMol). Lower the temperature to 6-9°C. Under good stirring, 60.00 g of piperacillin monohydrate (equivalent to 58.00 g of anhydrous acid; 11.2 cMol) and 7.25 g (2.4 cMol) of tazobactam (piperacillin and tazobactam) were added in portions within 1 hour. Tan ratio is 8:1). Stirring was continued for 30 minutes while applying a vacuum of 20-30 mBar absolute. Determination of CO 2 Less than 75 mg / L (if higher, continue stirring under vacuum for another 30 minutes), adjust pH to 5.5-7.0 by adding piperacillin monohydrate (PIP) or sodium bicarbonate (BIC) if necessary. The solution was then lyophilized.

[0150] initial pH

Embodiment 3

[0152] To a 1 L stirred reactor was added 109 mL of water and 11.43 g of sodium bicarbonate (13.6 cMol). Lower the temperature to 6-9°C. Under good stirring, 72.90 g (13.6 cMol) of piperacillin monohydrate was added in portions over 1 hour. Stirring was continued for 30 minutes while applying a vacuum of 20-30 mBar absolute. Determination of CO 2 Less than 75 mg / L (if higher, continue stirring under vacuum for another 30 minutes), if necessary, adjust the pH to 5.5-7.0 by adding piperacillin monohydrate (PIP) or sodium bicarbonate (BIC). The solution was then lyophilized.

[0153] initial pH

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PUM

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Abstract

The invention discloses an improved process for the production of lyophilized Piperacillin alone or in combination with Tazobactam with improved pH adjustment, by degassing the solution of products to a controlled low carbon dioxide content prior to lyophilization.

Description

technical field [0001] The invention relates to a method for preparing freeze-dried piperacillin sodium and a method for preparing freeze-dried piperacillin sodium and tazobactam sodium. [0002] Piperacillin alone or in combination with tazobactam administered intravenously as an antibiotic can be used in hospitalized patients with severe infections. [0003] In particular, the present invention relates to methods that also include controlling the carbon dioxide content prior to lyophilization. The products obtained in this way have increased pH stability, thus avoiding the formation of particulates in solutions for parenteral administration without the need for additional addition of other ingredients such as buffers or chelating agents. Background technique [0004] Piperacillin sodium alone or in combination with tazobactam sodium as an antibiotic for the treatment of moderate to severe infections caused by microbial strains such as hospital-acquired pneumonia caused by...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19
CPCA61K31/496A61K9/19A61K31/43A61P31/04Y02A50/30A61K2300/00
Inventor J·迪亚戈J·卡布里J·萨尔瓦多P·略韦拉斯I·科西勒克N·拉特茨尔
Owner SANDOZ LTD
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