Investigation of the bioequivalence of montelukast chewable tablets after a single oral administration using a validated LC-MS/MS method

Figures & data

Figure 1 Chemical structure of montelukast.

Figure 2 Plasma montelukast geometric mean concentration (ng/mL) versus time (hr) curves and log plasma montelukast geometric mean concentration versus time (hr) curves following a single oral dose of 5 mg chewable tablets.

Note: Triangle represents montelukast (test) and circle represents Singulair^® pediatric (reference).
Abbreviation: hr, hour.

Table 1 Summary of calculated PK parameters

PK parameters	Geometric mean	Minimum	Median	Maximum
Test formulation: montelukast containing montelukast 5 mg chewable tablets (batch number 1303111)
Cmax(ng/mL)	253.034	146.687	257.286	360.264
AUC0→last (ng·hr/mL)	1,449.910	713.579	1,522.708	2,735.068
AUC0→inf (ng·hr/mL)	1,516.558	776.492	1,590.272	2,885.412
Tmax(hr)	2.36	1.50	2.50	3.25
t1/2 (hr)	3.84	2.11	3.89	6.62
MRTinf (hr)	6.34	4.03	6.35	9.35
Residual area (%)	4.067	2.205	3.570	10.093
Reference formulation: Singulair^® pediatric containing montelukast 5 mg chewable tablets (batch number 322559)
Cmax (ng/mL)	257.920	133.041	261.842	409.845
AUC0→last (ng·hr/mL)	1,431.903	702.402	1,328.291	2,652.547
AUC0→inf (ng·hr/mL)	1,493.326	731.565	1,390.724	2,747.167
Tmax (hr)	2.48	1.50	2.38	5.00
t1/2 (hr)	3.75	2.77	3.61	6.15
MRTinf (hr)	6.24	4.63	6.03	10.44
Residual area (%)	3.895	2.012	3.837	8.563

Abbreviations: PK, pharmacokinetic; AUC, area under the curve; C_max, peak plasma concentration; T_max, time of peak plasma concentration; t_1/2, elimination half-life time; hr, hour; MRT, mean residence time.