In Vitro Comparative Quality Attributes of Selected Brands of Fexofenadine Hydrochloride Tablets Marketed in UAE and India

Abstract

The quality of pharmaceutical formulations has become a global concern due to the widespread counterfeit and substandard products that are available in the global market. Therefore, it is mandatory for the drug manufacturers to assess the quality standards of their formulations. Fexofenadine hydrochloride is a piperidine derivative indicated for various seasonal allergic rhinitis conditions such as rhinorrhea, sneezing nose, throat and itchy eyes. The aim of the present work was to evaluate the quality attributes of different brands of fexofenadine hydrochloride tablets having a strength of 180 mg using pharmacopeial and non-pharmacopeial methods. Two brands were bought from a retail pharmacy in India and the remaining two were bought from a local pharmacy in the Emirate of Ajman, UAE. The results of physical and chemical analyses were statistically evaluated using one tail t-test, when appropriate, to compare between different fexofenadine hydrochloride products with the innovator product. Identification, weight variation, disintegration and friability results were met by all the brands as per the British Pharmacopoeia 2018 specifications. However, brands from Indian market showed percentages of dissolved fexofenadine hydrochloride less than the allowed pharmacopeial lower limit of 80.0% after 45 min, while brands from UAE market represented dissolved concentrations laid within the acceptable range (≥80.0%). Additionally, brands from Indian market showed percentage contents of active ingredient range from 75.1 to 80.5% for brand I and 91.4–97.8% for brand II. Brands from UAE market showed percentages of fexofenadine hydrochloride ranges from 93.2 to 100.0% for brand III and from 96.5 to 102.3% for brand IV. Brand I and II showed significant differences with the originator brand IV.