Therapeutic Potential of Antileukotriene drug-Camellia sinensis extract co-formulation on Histamine induced Asthma in Guinea Pigs.

OBJECTIVE To study therapeutic potential of Antileukotriene drug- Camellia sinensis extract co-formulation on histamine induced asthma in guinea pigs. METHOD SRSD of Montelukast sodium was prepared by solvent evaporation method. Lyophilized aqueous extract of Camellia sinensis leaves and SRSD mixture was filled in capsule and capsule shell was coated to achieve initial release lag time. In vitro and pharmacokinetic study of capsules was done and compared with commercial tablets. 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 serum of control and experimental animals. RESULTS The drug release from commercial tablet was immediate and rapid but capsule has shown initial 3.5 hr lag time followed by sustained action up to 8 hr. Pharmacokinetic results shows that studied formulations are bioequivalent with respect to Cmax and AUC, while rest parameters showed significance difference. Mast cells count in lung tissue were increased (p<0.001) in experimental group along with glycoprotein deposition in asthmatic bronchioles. Level of SOD and GPX were decreased (p<0.05) while CAT is increased (p<0.04) in asthma group in comparison to control. CONCLUSION In the experimental animal model, co-formulation was effective in modulating allergic inflammation and contributing to a 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.