Formulation and Characterization of Mouth Dissolving Tablet of Levocetrizine Hydrochloride

Mouth dissolving tablets one of the novel approaches in improving patient compliance. Levocetrizine hydrochloride the non-sedative antihistamine drug commonly used for the treatment of allergic rhinitis. Tablet containing levocetrizine with Doshion P54 (C) resin and different superdisintegrants like Sodium starch glycolate, crospovidone, and polacrilin potassium were used for the manufacturing of tablet. Direct compression technique is used for manufacturing of tablet. Combinations of excipients were incorporated to formulate the tablet. Effect of the combinations were studied to optimize the formulation. Compatibility between the drug and excipients were performed with the help of FTIR spectral analysis. The tablets were evaluated for their hardness, wetting time, disintegrating time and dissolution parameters. It was concluded that the tablets having the combination of drug with Sodium Starch Glycolate  and Polacriline Potassium  met all the evaluation parameters and thus selected as the optimized formulation. The optimized formulation was undergone for stability studies in predicting the shelf-life as per ICH guidelines and proved  for its adequate shelf-life. Key words: Mouth dissolving tablet , Levocetrizine hydrochloride, FTIR, ICH guidelines.