Formulation and Evaluation of Ketorolac Tromethamine Mouth Dissolving Tablets

Abstract

Due to more versatility and comfort, mouth dissolving tablets are the most advanced type of oral solid dosage forms. Compared to conventional tablets, it increases the effectiveness of APIs by dissolving within a minute in the oral cavity after contact with less saliva, without chewing and without the need for water for administration. Mouth Dissolving Tablets of Ketorolac tromethamine were prepared by direct compression method using various superdisintegrants like crospovidone, Croscarmellose sodium, and Sodium starch glycolate in different concentrations. Prepared tablets were evaluated for hardness, friability, weight variation, disintegration time, wetting time and in vitro drug release. Results of pre-compression and post-compression studies of all formulations were found within the standard limits. The tablets of all the batches were found to release more than 80% of drug in 5 minutes, which is the desired quality of mouth dissolving tablets that helps in faster absorption of the drug and quick onset of therapeutic effect. The the order of dissolution of various disintegrants was found to be Crospovidone˃ SSG˃ CCS. There was no significant variation in drug content of drug during stability studies for selected batch F3 in accelerated conditions over three months. It was concluded from the study that fast release of Ketorolac tromethamine from formulation F3 may reduce onset of drug action with better patient compliance.
 Keywords: Crospovidone, Croscarmellose sodium, Ketorolac tromethamine, Mouth dissolving tablets, Sodium starch glycolate, superdisintegrants.