Evaluation of Orally Disintegrating Tablet Formulations in The Treatment of Oral Mucositis

Abstract

Aim: Orally disintegrating tablets (ODT) are widely used dosage forms with high patient compliance, which preferred in the treatment of many diseases currently. In this study we aimed to develop an orally disintegrating tablet formulation can be preferred in the treatment of oral mucositis, which often occurs after chemotherapy during cancer treatment. Methods: Lidocaine hydrochloride, which is a local anesthetic substance, was used as active pharmaceutical ingredient to obtain ODT formulation for the treatment of oral mucositis. ODTs were prepared by direct compression technique and crospovidone was used as super-dispersant Results: The method developed for lidocaine determination was validated. Characterization of powder mixtures conducted; angle repose was found to be as 25.78°±0.810, flow time was 4.18±0.772 s, compressibility index was 9.591±0.774% and Hausner’s ratio was calculated as 1.106±0.014. The uniformity of weight and content for the ODT formulation was 493.705±3.583 g, 78.89+2.546 mg, respectively. The tablets had a diameter of 12.031 ±0.015 mm while thickness was 4.420 ±0.021 mm. The hardness was calulated as 28.7±1.123 N, while percent friability value was 0.76%. Disintegration time of the tablets were 31.55±0.354 sec., and approximately 90% of the prepared formulation dissolved in around 20 minutes according to dissolution testing. Conclusions: The prepared formulation was evaluated through powder and tablet controls, it was found to comply with the limits specified in the European Pharmacopoeia. The developed ODT formulation for the treatment of oral mucositis, is planned to be evaluated through in vivo tests to complete the assessment of the formulation.