Background/Objective: To study the therapeutic potential of Antileukotriene drug-
Camellia sinensis extract co-formulation on histamine induced asthma in guinea pigs.
Methods: SRSD of Montelukast sodium was prepared by the solvent evaporation method. Lyophilized
aqueous extract of Camellia sinensis leaves and SRSD mixture was filled in capsule and the
capsule shell was coated to achieve initial release lag time. In vitro and pharmacokinetic study of
capsules was performed and compared with commercial tablets. A further role of green tea, as an
antioxidant adjunct for asthma management, has been analyzed by lung histology, mast cell count
and oxidative stress assay in the serum of control and experimental animals.
Results: The drug release from the commercial tablet was immediate and rapid, but capsule has
shown an initial 3.5 hr lag time followed by sustained action up to 8 hr. Pharmacokinetic results
show that studied formulations are bioequivalent with respect to Cmax and AUC, while rest parameters
showed asignificant difference. Mast cells count in lung tissue were increased (p<0.001) in
the experimental group along with glycoprotein deposition in asthmatic bronchioles. Levels of
SOD and GPX were decreased (p<0.05) while CAT was increased (p<0.04) in the asthma group in
comparison to control.
Conclusion: In the experimental animal model, co-formulation was effective in modulating allergic
inflammation and contributing to better control of the inflammatory response. Our findings
suggest that Camellia sinensis leaves extract may be used as an adjunct for future improvements in
asthma treatment and prevention.