Formulation and evaluation of montelukast sodium and levocetirizine dihydrochloride sublingual tablets
Abstract
Objective: The objective of the current study was to develop and optimize sublingual tablets of montelukast sodium and levocetirizine dihydrochloridewhich are effective drugs in the treatment of asthma.Methods: The sublingual tablets of montelukast sodium and levocetirizine dihydrochloride were prepared by direct compression method usingsodium starch glycolate, crospovidone (CP), and croscarmellose sodium (CCS) as superdisintegrants. The tablets were evaluated for physicalproperties including hardness, weight variation, thickness, friability, drug content, wetting time, water absorption ratio, in vitro disintegration time,and in vitro dissolution study.Results: The hardness, weight variation, thickness, friability, and drug content of tablets were within pharmacopoeial limits. An optimized tabletformulation F8 was found to have short wetting time of 18.36 seconds, water absorption ratio of 94.42 and in-vitro disintegration time of 45.42 seconds.The results indicated that the amount of super disintegrants such as CP and CCS significantly affected the dependent variables like wetting time, waterabsorption ratio and in-vitro disintegration time. The in-vitro drug release was found to be higher for formulation F8 with 94.59% for montelukastsodium and 95.48% for levocetirizine dihydrochloride within 60 minutes. The drug release improved by 1.88 times for montelukast sodium and1.82 times for levocetirizine dihydrochloride compared to oral marketed immediate release tablet…
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