Abstract
Objective: The aim of the present research work was to prepare and evaluate taste-masked oral disintegrating tablets (ODT) of Fexofenadine hydrochloride. Methods: In the present work, Eudragit EPO, a taste masking agent and Karaya gum (GK) (natural), Sodium starch glycolate, and Croscarmellose sodium (CCS) (semi-synthetic) super disintegrants in three ratios (3, 6,9%) were used. Taste masked granules were prepared by different ratios of the drug: Eudragit EPO (1:1, 1:1.5, 1:2) by wet granulation method. The optimized taste-masked granules (1:2) were selected by sensory evaluation test to prepare 9 Fexofenadine ODT (FH1-FH9) formulations. These were evaluated for different parameters. Then desirability function (DF) was calculated for all formulations using disintegration time (DT), time taken for the tablet to release 90% of the drug (t 90%), and % drug dissolved in 10 min (Q10) as significant parameters. Results: The best formulation (FH6) showed the highest DF value due to less DT and 100% in vitro drug release within 15 min. Thus, FH6 formulation containing 9% CCS was selected as the best among the prepared formulations to which in vivo studies were performed on rabbits to find maximum plasma concentration (Cmax), time taken to reach maximum concentration (tmax), area under the curve (AUC), rate of elimination (Kel), absorption rate (Ka) and half-life(t1/2) and compared with Fexofenadine (Allegra) marketed tablets. Total bioavailability was increased for the test formulation compared to the reference formulation. Conclusion: Fexofenadine was successfully prepared as ODT with increased AUC and decreased tmax to which stability studies were conducted which were found to be stable.
Highlights
The most widely used dosage forms are tablets and capsules
As Oral disintegrating tablets (ODT) disintegrate in the oral cavity within a matter of few seconds, these are very much useful for patients who are suffering from dysphagia [4, 5]
The taste of taste-masked granules prepared with different ratios of the drug: Eudragit E100 (TFH1, TFH2, TFH3) was evaluated by taste scores of bitter intensity scale given by six volunteers
Summary
The most widely used dosage forms are tablets and capsules. Oral disintegrating tablets (ODT) represent a rapidly emerging drug delivery system with better patient compliance and are very helpful for patients who have difficulty in swallowing [1,2,3]. As ODTs disintegrate in the oral cavity within a matter of few seconds, these are very much useful for patients who are suffering from dysphagia [4, 5]. These orally disintegrating tablets release the medicament in the mouth for absorption through local oromucosal tissue and through pre-gastric (oral cavity, pharynx, and esophagus), gastric (stomach) and post-gastric (small and large intestine) segments of the GastroIntestinal Tract. Oral disintegrating dosage forms are suitable for patients who have difficulty swallowing traditional tablets with a glass of water
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