• NEELAM SINGH Department of Pharmaceutics, ITS College of Pharmacy, NH-58, Ghaziabad - 201 206, Uttar Pradesh, India.
  • Giriraj T Kulkarni Amity Institute of Pharmacy, Amity University Uttar Pradesh, Sector 125, Noida 201303, India
  • Yatendra Kumar I.T.S College of Pharmacy, NH-58, Delhi Meerut road, Ghaziabad, 201206, India
  • GIRIRAJ T KULKARNI Department of Pharmaceutics, Amity Institute of Pharmacy, Amity University Uttar Pradesh, Sector 125, Noida - 201 303, Uttar Pradesh, India.


Objective: Pharmacokinetic evaluation of montelukast sodium chronomodulated capsules (sustained-release solid dispersion of drug enclosed in pH-sensitive film-coated hard gelatin shell) and marketed tablets has been carried out in this study.

Methods: A single oral dose of prepared capsules and marketed conventional tablets was administered in healthy male Dunkin-Hartley albino guinea pigs. Blood samples were collected at different time intervals and plasma concentration of drug was determined by reversed-phase high-performance liquid chromatography. Different pharmacokinetic parameters were assessed from plasma drug concentration-time profile by one-compartment model, first-order kinetics.

Results: Pharmacokinetic parameters such as time to reach maximum concentration, elimination rate constant, elimination half-life, and mean residence time data indicates that drug release from chronomodulated capsules is significantly prolonged with initial release lag time of 3.5–4 h in comparison with marketed conventional tablets. However, maximum drug plasma concentration, area under the concentration-time curve, and apparent volume of distribution values show non-significant difference between capsules and marketed tablets.

Conclusion: The findings specified that capsules were providing time controlled delivery of drug at a desired rate for prolonged time, which may be helpful for the prevention of episodic attack of asthma in early morning hours.

Keywords: Montelukast sodium, Pharmacokinetics, High-performance liquid chromatography, Guinea pig plasma, Sustained-release solid dispersion, pH-sensitive coating.

Author Biography

NEELAM SINGH, Department of Pharmaceutics, ITS College of Pharmacy, NH-58, Ghaziabad - 201 206, Uttar Pradesh, India.



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How to Cite
SINGH, N., G. T. Kulkarni, Y. Kumar, and G. T KULKARNI. “PHARMACOKINETIC COMPARISON OF MONTELUKAST SODIUM FORMULATIONS AFTER A SINGLE ORAL DOSE IN HEALTHY GUINEA PIGS”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 12, no. 2, Jan. 2019, pp. 165-9, doi:10.22159/ajpcr.2019.v12i2.29279.
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