Pharmacodynamics of nine generic products of amikacin compared with the innovator in the neutropenic mouse thigh infection model

BMC Research Notes

Omar Vesga¹  Maria Agudelo¹  Carlos A. Rodriguez²  Andres F. Zuluaga² 

[1] Infectious Diseases Unit, Hospital Universitario San Vicente Fundación, Medellín, Colombia;Department of Pharmacology and Toxicology at Medical School, Universidad de Antioquia, Calle 70 No. 52-21, Medellín, Colombia

关键词: Antimicrobial resistance;    Therapeutic equivalence;    Generics;    Animal models;    Amikacin;   

Others  :  1229616
DOI  :  10.1186/s13104-015-1507-z

 received in 2015-06-02, accepted in 2015-09-21,  发布年份 2015

【 摘 要 】

Background

Previously, we validated the mouse thigh infection model to test the therapeutic equivalence of generic antibiotic products. Here, our aim was to compare the in vivo efficacy of amikacin products in clinical use in Colombia using this animal model.

Results

All except one generic product had the same in vitro potency, judging by the lack of differences on MIC and MBC compared with the innovator. However, eight of nine generic products failed in the neutropenic mouse thigh infection model to achieve the innovator’s maximum effect (E _max  ≤ 5.65 for the generics vs. 6.58 log ₁₀CFU/g for the innovator) against Escherichia coli SIG-1, after subcutaneous treatment every 6 h with doses ranging from 1.5 to 3072 mg/kg per day.

Conclusion

As we demonstrated previously with other antibiotics such as vancomycin, gentamicin and oxacillin, the generic products of amikacin failed the in vivo efficacy testing. The therapeutic equivalence should be assessed in vivo before clinical approval of generic products.

【 授权许可】

   
2015 Zuluaga et al.

【 图 表 】

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