Abstract

FORMULATION AND EVALUATION OF ORAL FAST DISSOLVING FILMS OF LEVOCETIRIZINE

Mohammed Asadullah Jahangir, Dr.M.A.Saleem*, Hasham Rizwan Patel, Imran Kazmi, Abdul Muheem, Kamran Ahmad

ABSTRACT

Levocetirizine is a selective, long acting peripheral H1receptor antagonist. Allergic rhinitis is a symptomatic disorder of the nose induced by inflammation mediated by immunoglobulin E (IgE) in the membrane lining the nose after allergen exposure. Thus, formulating Levocetirizine into a fast dissolving dosage form would provide fast relief. Levocetirizine is bitter in taste so ß-cyclodextrin was used to mask the taste. Inclusion complexes of drug ß-cyclodextrin were prepared by kneading method in 1:1 molar ratios. The prepared inclusion complexes were characterized by FTIR spectroscopy suggesting no interaction. The oral fast dissolving films were prepared by using different polymers like HPMC, PVA, PVP and carbopol 934P with super disintegrants like sodium starch glycolate and croscarmellose sodium. The prepared films evaluated for folding endurance, swelling index, surface pH, in vitro disintegration time, drug content, FTIR Study, Scanning electron microscopy and in vitro drug release. The physical appearance and folding endurance properties were found to be good and electron microscopy shows that films are clear, colourless with smooth surface without any scratches. The average folding endurance time found within the range of 121 to 198 times. The drug content found to be 93.33% to 98.68% shows uniform mixing of drug in all prepared fast dissolving films. The in vitro disintegration time found to be in the range of 15 to 48sec and the surface pH of the all formulations was in the range of 6.06 to 6.83. The in vitro drug release showed 77.77 to 96.80 % drug release within 10 minutes. The formulations F7 to F12 showed highest drug release which contains croscarmellose as superdisintegrant, among these formulations F7, F8 and F11 showed highest drug release.

Keywords: Levocetirizine, ß-cyclodextrin, Hydrophilic Polymers, Superdisintegrants, oral fast dissolving films.