Omadacycline: impurity studies of a new tetracycline antibiotic
Time:2024-06-25
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Omadacycline, a new antibacterial drug, is a new 9-aminomethylcycline antibiotic, the chemical structure of which differs only by one carbonyl group from that of tigecycline, and its main structural feature is the modification of the aminomethyl group at the C9 position on the basis of the structure of minocycline, which can help Omadacycline to overcome the bacterial drug resistance, expand the antimicrobial spectrum, and improve the pharmacokinetic properties. It is the first aminomethyl tetracycline for clinical application.
In clinical trials, omadacycline was found to be broad-spectrum and safe, with rapid onset of action, significant efficacy in empirical treatment of lung infections, comprehensive coverage of common pathogens in community-acquired infections, and significant efficacy against atypical pathogens. In 2018, its intravenous and oral tablets were approved for marketing by the U.S. Food and Drug Administration (FDA) for the treatment of adults with CABP and ABSSSI. omadacycline was no less efficacious than moxifloxacin and linezolid and had a favourable safety profile in three pivotal global studies.
In January 2020, omadacycline received support from the 2019 Implementation Plan of the Major New Drug Creation and Manufacturing Project, and was granted priority approval status by the National Drug Administration (NMPA) Drug Evaluation Centre in April as an innovative drug with obvious therapeutic advantages. (NMPA) Drug Evaluation Centre in April, as an "innovative drug with obvious therapeutic advantages".
Omadacycline advantage of a wide range of pathogens, can be used for a variety of well-defined pathogens caused by infections, in addition to the study of the pharmacological mechanism, in terms of quality control, the U.S. Pharmacopoeia (USP) and the European Pharmacopoeia (EP) are included in the omadacycline of the relevant substances, residual solvents, and other impurities in the limit requirements for the individual impurities are usually in the limit of 0.1 per cent to 0.2 per cent, and the total impurities controlled within 1.0/%.
More research and analysis of omadacycline is continuously exploring, SZEB has the advantage of supplying omadacycline impurity control/standard, go to the official website (ww.ex-biotech.com)to learn more about impurity information, we are at your service at any time!
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