To the Question of Interchangeability of Original and Generic Parenteral Antimicrobials | CMAC

To the Question of Interchangeability of Original and Generic Parenteral Antimicrobials

Clinical Microbiology and Antimicrobial Chemotherapy. 2010; 12(1):31-40

​ Nikulin A.A., Tzuman Yu.P., Martinovich A.A., Edelstein M.V., Kozlov R.S.
meropenem generic high performance liquid chromatography
Section
Antimicrobials
Type
Journal article
Publication
Clinical Microbiology and Antimicrobial Chemotherapy. 2010; 12(1):31-40

Introduction.

In the conditions of dramatic rising of antibacterial resistance of gram-negative nosocomial pathogens, carbapenems plays a leading part as empiric antibacterial therapy, particularly in severe infections. Carbapenems on Russian pharmaceutical market presented by the original products and the number of generics from the India and other countries.

Objective.

The aim of the study was to compare the quality of original meropenem product and one of the generics.

Materials and Methods.

A total of 30 vials of «Meronem» (10 vials from 3 distinct series) and 20 vials of «Meropenem Spencer» were assayed. The stability of meropenem after reconstitution of vial’s content with water was assayed at 12 and 24 hours of storage at room temperature in darkness. For the determination of concentration and stability of active compound, and spectrum and quantity of soluble impurities, high performance liquid chromatography was used. The analysis of insoluble particulate contamination was performed by vials contents vacuum-filtering through 0.45-µm analytical filters after complete reconstitution in water and with following digital microscopy of the filters.

Results.

The «Meronem» (AstraZeneca UK Ltd.) samples contained from 96.53% to 102.73% (mean+SD: 99.61±1.74%), and the «Meropenem Spencer» (Cooper Pharma Ltd.) samples contained from 95.02% to 101.97% (mean+SD: 98.19±1.96%) of the claimed meropenem content. The contents of all «Meronem» vials had dissolved completely in less than 5 min, while the time required for dissolution of «Meropenem Spencer» varied from 20 min to 3 hours, and vials of «Meropenem Spencer» contained visible solids even after 4 hours of reconstitution with continuous agitation. The sampled vials of «Meronem» (AstraZeneca UK Ltd.) were free of noticeable particulate contaminations. At the same time, the sampled vials of «Meropenem Spencer» (Cooper Pharma Ltd.) contained different amounts of insoluble contaminants.

Conclusions.

Though samples had no significant discrepancies in concentration and stability of the active compound, the «Meropenem Spencer» samples characterized by inadmissible long time required for dissolution of vial contents and contained different amounts of insoluble contaminants that can adversely affect the effectiveness of therapy.

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