Formulation and Evaluation of Fexofenadine Hydrochloride Orally Disintegrating Tablets for Pediatric Use

Abstract

Allergic rhinitis is a common disease in children which has considerable negative effects on the quality of life. Fexofenadine hydrochloride (FFH) is a second-generation oral antihistamine which has been widely perscribed for alleviating symptoms of AR in children. The aim of this study was to take the advantage of convenient direct compression method for preparation of Orally Disintegrating Tablets (ODTs) containing 30 mg FFH per tablet. Six ready-to-use commercial tablet excipients (F-Melt (R), Pearlitol (R) Flash, Pharmaburst (R) 500, Prosolv (R) Easytab SP, Ludiflash (R), Parteck (R) ODT (R)) were used for direct compression and suitability of these excipients were evaluated. ODTs could be successfully compressed with all the investigated excipients and all of the formulations exhibited acceptable crushing stregth, low friability and remarkably short disintegration time. The ODTs which were able to possess a disintegration time below 30 s were considered eligible for further studies. In vitro dissolution studies showed a complete release of the drug from ODTs made from Pharmaburst (R) 500 within 15 min. Short term stability results exhibited no significant change of the drug in tested formulations. In conclusion, FFH containing ODTs formulated with Pharmaburst (R) 500 were determined explicitly the most promising formulation when compressed at a force of 1000 kg.