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Pharmaceutical composition containing sulbactam and avibactam and application of pharmaceutical composition

A composition and medicine technology, applied to a pharmaceutical composition comprising avibactam and sulbactam, the application field in the treatment of bacterial infections, can solve the problem of less clinical application experience, high probability of adverse reactions, and low bacterial drug resistance Clinical efficacy and other issues

Pending Publication Date: 2021-10-29
TENNOR THERAPEUTICS (SUZHOU) LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are problems such as little clinical application experience and high probability of adverse reactions, and the sharp rise in bacterial drug resistance means that the existing clinical therapies have lower and lower clinical efficacy for patients with bacterial infections (China Bauman No. Expert consensus on the diagnosis, treatment and prevention of Acinetobacter infection, Chinese Journal of Medicine, 2012, 92, 76-85

Method used

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  • Pharmaceutical composition containing sulbactam and avibactam and application of pharmaceutical composition
  • Pharmaceutical composition containing sulbactam and avibactam and application of pharmaceutical composition
  • Pharmaceutical composition containing sulbactam and avibactam and application of pharmaceutical composition

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Experimental program
Comparison scheme
Effect test

Embodiment approach

[0217] 1. A pharmaceutical composition comprising sulbactam or a pharmaceutically acceptable salt thereof and avibactam or a pharmaceutically acceptable salt thereof, wherein the sulbactam or a pharmaceutically acceptable salt thereof The unit dose ratio of the avibactam or its pharmaceutically acceptable salt is about 8:1 to about 4:1, and the unit dose of the sulbactam or its pharmaceutically acceptable salt is about 1- 4g, the unit dose of the avibactam or its pharmaceutically acceptable salt is about 0.125-1g, and optionally a pharmaceutically acceptable carrier.

[0218] 2. The pharmaceutical composition according to embodiment 1, wherein the unit dosage ratio of sulbactam or a pharmaceutically acceptable salt thereof and avibactam or a pharmaceutically acceptable salt thereof is about 4:1.

[0219] 3. The pharmaceutical composition according to any one of embodiments 1-2, wherein the unit dose of sulbactam or a pharmaceutically acceptable salt thereof is about 1-3 g.

...

Embodiment 1

[0346] Example 1 Minimal inhibitory concentration test of sulbactam sodium and avibactam sodium to the first series of Acinetobacter baumannii clinical strains

[0347] The minimum inhibitory concentration (MIC) was determined based on the requirements of Clinical and Laboratory Standards Institute (CLSI) M07 (for aerobic bacteria).

[0348] 1. Test drug (combination):

[0349] Table 1 Test Drugs (Combinations)

[0350] compound (combination) Maximum concentration (μg / mL) Minimum Concentration (μg / mL) Sulbactam Sodium 64 0.06 Avibactam Sodium 32 0.5

[0351] 2. Test strains:

[0352] Table 2 Test strains (10 clinical strains in total)

[0353] Bacteria name Strain number culture medium Acinetobacter baumannii ATCC 19606 a Acinetobacter baumannii TNP041702 a Acinetobacter baumannii TNP041703 a Acinetobacter baumannii TNP041704 a Acinetobacter baumannii TNP041705 a Acinetobacter baumann...

Embodiment 2

[0369] Example 2 Sulbactam sodium and avibactam sodium are tested for the minimum inhibitory concentration of the second series of Acinetobacter baumannii

[0370] The minimum inhibitory concentration (MIC) was determined based on the requirements of Clinical and Laboratory Standards Institute (CLSI) M07 (for aerobic bacteria).

[0371] 1. Test drug (combination):

[0372] Table 5 Test Drugs (Combinations)

[0373] compound (combination) Maximum concentration (μg / mL) Minimum Concentration (μg / mL) Sulbactam Sodium 128 0.125 Avibactam Sodium 128 0.125 Sulbactam Sodium / Avibactam Sodium=1:1 64+64 0.063+0.063 Sulbactam Sodium / Avibactam Sodium=2:1 64+32 0.063+0.031 Sulbactam Sodium / Avibactam Sodium=4:1 64+16 0.063+0.016 Tigecycline 32 0.031 polymyxin 32 0.031

[0374] 2. Test strains:

[0375] Table 6 Test strains (20 strains in total)

[0376]

[0377]

[0378] Medium: a, CAMHB (cation adjusted Mueller-Hint...

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Abstract

The application relates to a pharmaceutical composition comprising sulbactam or a pharmaceutically acceptable salt thereof and avibactam or a pharmaceutically acceptable salt thereof. The unit dose ratio of the sulbactam or the pharmaceutically acceptable salt thereof to the avibactam or the pharmaceutically acceptable salt thereof is from about 8: 1 to about 4: 1, the unit dose of the sulbactam or the pharmaceutically acceptable salt thereof is about 1-4 g, the unit dose of the avibactam or the pharmaceutically acceptable salt thereof is about 0.125-1 g, and a pharmaceutically acceptable carrier is included optionally. The present application also relates to methods of treating bacterial infections using the pharmaceutical composition.

Description

technical field [0001] The present application relates to the field of biomedicine, in particular to a pharmaceutical composition comprising avibactam and sulbactam, and its application in treating bacterial infections. Background technique [0002] Bacterial infections (such as Acinetobacter baumannii) cause hospital-acquired pneumonia, bloodstream infection, abdominal infection, central nervous system infection, urinary system infection, skin and soft tissue infection, etc. With an increasing trend year by year, this problem has become a challenge in the field of global anti-infection. [0003] Due to the serious problem of drug resistance, there are very limited safe and effective drugs for the treatment of drug-resistant bacterial infections. For example, the drugs currently used to treat drug-resistant Acinetobacter baumannii include polymyxin, tigecycline, and sulbactam And a few drugs such as the compound preparation of β-lactamase inhibitor containing sulbactam and ...

Claims

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Application Information

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IPC IPC(8): A61K31/439A61K31/43A61K45/06A61K38/12A61K31/65A61P31/04A61P11/00A61P7/00A61P17/00A61P13/00A61P25/28
CPCA61K31/439A61K31/43A61K9/0019A61K45/06A61K38/12A61K31/65A61P31/04A61P11/00A61P7/00A61P17/00A61P13/00A61P25/28A61K2300/00A61K31/4188A61K31/546
Inventor 马振坤徐悦刘宇王唤贺世杰张燕顾振兴徐向毅
Owner TENNOR THERAPEUTICS (SUZHOU) LTD
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