Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study

Table 1

Comparative pharmacokinetic parameters of serum and lung of both formulations azithromycin-based assayed.

PK parameter	AZM reference	AZM generic
Serum
𝐶max (µg/mL)	2.40±0.10	2.60±0.23
𝑇max (h)	1.00±0.00	2.50±0.00
AUC (μg⋅h/mL)	34.5±2.50	33.3±1.50
SDP (h)	0.5–2.4	0.5–24
Lung
𝐶max (µg/mL)	45.0±3.00	101±10.4 ***
𝑇max (h)	0.50±0.00	0.50±0.00
AUC (μg⋅h/mL)	1022±53.0	60.6±5.00 ***
LDP (h)	0.5–2.5	0.5–24

PK Values are showed as the average of the 3 different assays.
***Values statistically different to the Reference group at 𝑃<0.001.
𝐶_max: maximum serum concentration peak, 𝑇_max: time at 𝐶_max; AUC: area under the concentration versus time curve; SDP: Serum Detection Period; LDP: Lung Detection Period.