Formulation and in-vitro evaluation of Levocetirizine dihydrochloride and Montelukast sodium bilayered tablet for bi-modal drug release
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2014, Vol 2, Issue 6
Abstract
The present study aims to formulate and evaluate Levocetirizine hydrochloride and Montelukast sodium bilayered tablet for treating nasal allergic rhinitis effectively. By combining Levocetirizine with Montelukast gives additional benefits in comparison with either drug alone and could be considered for patients whose quality of life is impaired by persistent allergic rhinitis. Bilayered tablet may be designed for one layer for the immediate release of the drug and second layer for extended release thus maintaining a prolonged blood level. To achieve patient compliance by reduced frequency of drug administration, and reduced side effects. Bilayer tablets were formulated using wet granulation method for Montelukast Sodium and direct compression method for Levoceterizine dihydrochloride. Preparation of sustained release layer Using Xanthum gum, HPMC k100 as polymers and pvp-k30, iso propyl alcohol as binders, microcrystalline cellulose and magnesium stearate as lubricants. By using both polymers drug release rate was retarded upto 12 hours and immediate release layer using sodium starch glycolate, croscarmellose sodium and povidone as superdisintegrants and diluents like mannitol, sodim stearyl fumarate, sodium saccharin, microcrystalline cellulose. By using croscarmellose sodium. Within 15 min 98 percent of drug was released. The powder blend was subjected for pre-compressional parameters such as bulk density and tapped density, angle of repose, compressibility index and hausner’s ratio. The prepared tablets are evaluated to post-compressional parameters such as hardness, friability, average weight, uniformity of weight and in-vitro dissolution studies. Drug compatibility with excipients was checked by FT-IR studies. The values of pre-compressional parameters evaluated were within prescribed limits and indicated good free flowing property. The values of post-compressional parameters evaluated were within acceptable limits. The dissolution profiles of all the formulations were evaluated. Amongst all the formulations, the release profile of formula f8, f5 gave optimum results. It was concluded that optimized bilayered Levocetirizine dihydrochloride F8 and Montelukast F5, is successful formulation and can be manufactured with reproducible characteristics from batch to batch. The optimized formulation f8, f5 was compared to the marketed product and hence found to be superior over the marketed product.
Authors and Affiliations
Syed Ashrafa, B. Pragati Kumar, MD. Siddiquie Ahmed Khan
Keywords
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