In Vitro Pharmaceutical equvalence of fexofenadine tablets

Abstract

Introduction: the differnce in the production process applied in pharmaceutical companies can affect the quality of phramaceutical products. Hence, the Alignment of pharmaceutical products with their innovators is most importance. Purpose: The aim of this study is to align domestic trade tablets of Fexofenadine with their foriegn counterpart,Telfast 120 mg. Fexofenadine contains chiral carbon and its powder is in the form of racemic. the plasma concentration of R enantiomer is more than S enantiomer in case that the affinity of S enantiomer towards P-glycoprotein is more. Pharmacokinetic of Fexofenadine is the result of stereoselection P-glycoprotein(efflux) in the small intestine. Method: In the current study, 6 domestic brands of fexofenadine tablets ,along with a foreign brand, have been experimented in vitro, including assay, weight variation, content uniformity,Dissolution test and Enantiomers separation of Fexofenadine by HPLC method Results: Given assay and content uniformity , the experimented products are in acceptable range of pharmachopia.In the dissolution test,in 30 minutes 60 percent of the active ingredients were released from each pharmaceutical product but products 3 and 4 which had a release percentage of 50 percent.Regarding the percentage of enantiomers, only the domestic product No. 2 had a similar rate of dissolution to its foreign counterpart. In terms of friability percentage, The tablets of all tested brands had friability percentage of less than 0.1%. Comparing the percentage of enantiomer in pills only the drug product 2 was in the close proximity of the reference product and there was a significant difference in the rest of the products. Conclusion: The drug number 2 was the most similar to Telfast 120 mg in terms of the amount of effective drug, solubility and percentage of enantiomers.