Preparation and evaluation of fexofenadine hydrochloride orally disintegrating tablets using neem gum as binder

Journal Article
Wajid, Vamshi Vishnu Yamsani , Shiva Kumar Ravula , Krishna Reddy Togaru , Mamatha Reddy Peesari Mohamed N. Al-Arifi , Syed . 2014
Publication Work Type: 
Research paper
Tags: 
Fexofenadine hydrochloride, Neem gum, Aspartame, tartaric acid, ODT, Superdisintegrants
Magazine \ Newspaper: 
Journal
Issue Number: 
7
Volume Number: 
8
Pages: 
864-870
Publication Abstract: 

The purpose of this study is to mask the intensely bitter taste of Fexofenadine hydrochloride and to formulate an orally-disintegrating tablet (ODT)) of the taste-masked drug by using Neem gum as binder in wet granulation method. The methods commonly employed for achieving effective taste masking include various physical and chemical methods that prevent the drug substance from interaction with the taste buds. In this present study we have evaluate the Neem gum as the binder in wet granulation method to prepare ODT. Sodium starch glycolate, cross povidone and croscarmellose sodium are used as Superdisintegrants to prepare ODTs with better release. Granules of Fexofenadine hydrochloride are prepared by wet granulation method and evaluated for pre-compression parameters. Neem gum concentration is optimized to prepare ODT with the help of invitro evaluation studies. With the help of in-vivo taste evaluation the optimum combination (2:1:0.5) of the drug - tartaric acid – aspartame is determined. Fast dissolving tablets of diclofenac sodium are prepared using this ratio of drug – tartaric acid – aspartame and the Superdisintegrants (4-6%) and evaluated for post compression parameters. Effect of Superdisintegrants on wetting time, disintegrating time, drug content, in-vitro release, have been studied. Based on these tests the formulations containing 6% of cross povidone is selected as the optimum formulation. Short-term stability studies on promising formulations indicated that there are no significant changes.