Delving into the Latest Updates on Etimicin Sulfate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Antibiotic 89-07, Etimicin, Etimicin Sulfate and Sodium Chloride

+ [7]

Target

30S subunit

Mechanism

30S subunit inhibitors(30S ribosomal subunit inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Bacterial InfectionsBronchiectasisPseudomonas aeruginosa infection

Inactive Indication-

Originator Organization

Hangzhou Aida Pharmaceuticals Co. Ltd.

Active Organization

Jiangxi Aishite Pharmaceutical Co., Ltd.

Wuxi Jemincare Shanhe Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (01 Jan 1999),

Bacterial Infections

Regulation-

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Structure

Molecular FormulaC21H45N5O11S

InChIKeyOEBISAUVQBGQKC-ZIZSAZPJSA-N

CAS Registry362045-44-1

View All Structures (2)

BACKGROUNDThis phase I clinical study aimed to assess the safety, tolerability, and population pharmacokinetic-pharmacodynamics (PK-PD) target attainment analysis of etimicin sulfate in healthy participants, and to provide scientific reference for further development of clinical breakpoints.METHODSA total of 24 healthy Chinese subjects were enrolled in this study and received an etimicin sulfate infusion. A population PK model was constructed for the estimation of the PK profiles of etimicin sulfate. The area under the concentration-time curve divided by the minimum inhibitory concentration (AUC_0-24h/MIC) and the peak concentration divided by the MIC (C_max/MIC) were selected as the PK/PD indices. The probability of target attainment (PTA) was calculated for each designed dosing regimen using Monte Carlo simulations. The minimum MIC value with a PTA ≥ 90% for each regimen was considered as the PK/PD cutoff values.RESULTSEtimicin sulfate demonstrated safety, tolerability, and predictable PK characteristics. No deaths or serious adverse events were reported. Seven treatment-emergent adverse events (TEAEs) were reported by five participants; all TEAEs were minor and were rapidly relieved. A two-compartment model was developed and validated for describing the PK features of etimicin sulfate among Chinese healthy participants. The diagnostic goodness-of-fit plots and visual predictive check plots showed that this developed model could describe these data well.CONCLUSIONSThe PTA results showed that etimicin sulfate provided clinical improvement against strains with an MIC of 0.5-1 mg/L and below, and antibacterial effect against strains with an MIC of 0.25 mg/L and below. However, etimicin sulfate had limited clinical efficacy for clinical isolates with MIC values > 1 mg/L.

01 Oct 2024·Journal of Pharmaceutical and Biomedical Analysis

Quantitative analysis of the impurities in Etimicin using hydrophilic interaction liquid chromatography coupled with charged aerosol detector

Article

Author: Gao, Jiarui ; Wang, Quan ; Zhu, Bingqi ; Wang, Jian ; Wang, Fan ; Wei, Xinyi

Etimicin is a typical aminoglycoside antibiotic (AG). High performance liquid chromatography-evaporation light scattering detector (HPLC-ELSD) method is a commonly used method for determining impurities in Etimicin. However, due to the poor reproducibility, low sensitivity and narrow linear range of the ELSD, high-throughput quantitative analysis of impurities in Etimicin currently poses a challenge. In this study, a sensitive method using hydrophilic interaction liquid chromatography coupled with charged aerosol detector (HILIC-CAD) was developed for the analysis of the impurities in Etimicin. The liquid phase conditions for determination impurities in Etimicin were optimized using Box Behnken design (BBD) and response surface methodology (RSM), resulting in satisfactory separation and optimal CAD output signal. We also studied the influence of CAD parameters on the signal-to-noise ratio and linearity of Etimicin and its impurities. This method has also been proven to be effective in separating impurities from two other typical AGs, Isepamicin and Amikacin. In the method validation, the coefficient of determination (R²) of Etimicin, Isepamicin and Amikacin and their impurities were all greater than 0.999, within the range of 0.5-50 μg/mL. The average recoveries of the impurities of three typical AGs were 99.03 %-101.22 %, RSDs all were less than 2.5 % for intra-day and inter-day precision, with good precision and accuracy. The developed HILIC-CAD quantification method was sensitive, accurate and highly selective for quantitative analysis of impurities in the AGs without need ion-pairing reagents, which is ensure the public medication safety. The method is first reported application of HILIC-CAD method for quantitative analysis of the impurities in AGs.

18 Jun 2024·Open Life Sciences

Rhodococcus equi and Brucella pulmonary mass in immunocompetent: A case report and literature review

Article

Author: Zhang, Lifang ; Li, Xicheng ; Zhang, Xuejuan ; Li, Pengfei

AbstractRhodococcus equi, predominantly recognized as an opportunistic pathogen affecting immunocompromised hosts, and Brucella, a widespread zoonotic bacterium, infrequently co-infect immunocompetent adults, thereby posing a distinctive diagnostic challenge. Here, we describe a case involving a 53-year-old male with a history of goat farming, who presented with persistent chest tightness, cough, and notable weight loss, absent fever. Radiological and bronchoscopic assessments showed a right hilar mass, extensive vertebral destruction, and bronchial lesions, deviating from the typical symptoms associated with either pathogen. Laboratory analyses confirmed a co-infection involving R. equi and Brucella. Initial therapy with levofloxacin and vancomycin proved ineffective; however, a subsequent treatment regimen comprising azithromycin, etimicin, minocycline, and moxifloxacin resulted in substantial clinical improvement. This case accentuates the intricacies involved in diagnosing and managing atypical co-infections in immunocompetent individuals and underscores the importance of careful microbiological testing to inform effective therapeutic strategies.

100 Deals associated with Etimicin Sulfate

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External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bacterial Infections	CN	Wuxi Jemincare Shanhe Pharmaceutical Co., Ltd.	01 Jan 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bronchiectasis	Phase 1	CN	Jiangxi Aishite Pharmaceutical Co., Ltd.	14 Jun 2024
Bronchiectasis	Phase 1	CN	Wuxi Jemincare Shanhe Pharmaceutical Co., Ltd.	14 Jun 2024
Pseudomonas aeruginosa infection	Phase 1	CN	Wuxi Jemincare Shanhe Pharmaceutical Co., Ltd.	14 Jun 2024
Pseudomonas aeruginosa infection	Phase 1	CN	Jiangxi Aishite Pharmaceutical Co., Ltd.	14 Jun 2024