Formulation and in vitro Evaluation of Taste-Masked Orodispersible Tablets of Levocetirizine Dihydrochloride

Abstract

The main aim was to formulate and evaluate and optimize taste- masked orodispersible tablets of Levocetirizine Dihydrochloride, a drug used in Allergic Rhinitis was prepared by direct compression method. The study involved different excipients which were used for the formulation and tested for their compatibility with Levocetirizine Dihydrochloride by the FT-IR studies. Based on the results of FT-IR studies, most of the excipients were found to be compatible with Levocetirizine which was used for the preparation of Levocetirizine oral disintegrating tablets. Levocetirizine Dihydrochloride is bitter in taste so the Tulsian-339 (ion exchange resin) was used to mask the taste to formulate an orodispersible dosage formulation using drug resin complex. Nine batches (F1-F9) of oro dispersible tablets of Levocetirizine Dihydrochloride were prepared by using super disintegrants like Sodium starch glycolate, Avicel PH102 and Low Hydroxy Propyl Cellulose in variable concentrations along with excipients for the development of optimized formulation. All formulations were subjected to evaluation studies of drug content, weight variation, water absorption ratio, wetting time, in vitro disintegration, dispersion time, hardness, friability and thickness uniformity. The tablets were disintegrated in vitro within 28-38 seconds, the complete drug was released from the tablets within 15 min. The results showed that Levocetirizine dihydrochloride was successfully formulated into an orodispersible dosage form.