Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study
- Rivulgo, Virginia Margarita
- Sparo, Mónica
- Ceci, Mónica
- Fumuso, Elida
- Confalonieri, Alejandra
- Delpech, Gastón
- Sanchez Bruni, Sergio Fabian
DOIAbstract
Azithromycin(AZM)therapeutic failure and relapses of patients treated with generic -35 formulations have been observed in clinical practice.The main goal of this research was 36 to compare in a pre-clinical study the serum exposure and lung tissue concentrationof 37 two commercial formulations AZM-based in murine model. The current study involved 38 264 healthy Balb-C.Mice were divided in two groups (n=44): Animals of Group A 39 (Reference Formulation ?R-) were orally treated with AZM suspension at 10 mg/kg of 40 b.w.Experimental animals of Group B (Generic formulation ?G-) received identical 41 treatment than Group A with a generic formulation AZM-based.The study was repeated 42 twice as Phase II and III. Serum and lung tissue samples were...
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