In Vitro Evaluation of the Bioequivalence of Different Brands of Doxycycline Marketed in Burkina Faso, Africa

Background: Post-marketing quality control of drugs is an essential activity for local health authorities.This study aimed to determine the physicochemical quality and compare the dissolution profile of four different brands of doxycycline tablets (100 mg) (as hyclate and monohydrate forms) marketed in Burkina Faso, Africa.Methods: Parameters such as mass uniformity, disintegration, active pharmaceutical ingredient (API) identification, assay, and dissolution were assessed according to the monograph of United States Pharmacopoeia.A bioequivalence test was performed in vitro, and comparative dissolution testing was performed in pH 1.2, 4.5, and 6.8 media according to ICH specifications.Results: All brands of doxycycline met the required specifications for physicochemical parameters.API content ranged from 92.49% ( 0.27%) to 101.00% ( 1.43%), and cumulative drug release ranged from 88.57% ( 0.74%) to 100.15% ( 3.84%) within 60 minutes.Only one brand of doxycycline hyclate tablet was considered not interchangeable with the comparator according to the difference factor (f1 = 14.83) and similarity factor (f2 = 43.63) in pH 6.8 medium.Conclusion: Despite the low level of doxycycline registered in Burkina Faso, quality control needs to be intensified to ensure the quality of the products marketed.