A Comparative Study of the Quality Attributes of Innovator and Generic Doxycycline Tablets

Abstract

Doxycycline is a well-known broad-spectrum antibiotic that has been artificially derived from the very well-known Oxytetracycline. The activity of Doxycycline is reported to be against a diverse range of microbes comprising of gram-negative bacteria, gram positive bacteria, anaerobic bacteria and parasites. Doxycycline is proved to be beneficial in managing RTIs, UTIs, skin and soft tissue infections. Five generic Doxycycline Hyclate 100 mg tablets from different manufacturer have been evaluated to assess their bioequivalence using in-vitro tests. Other general quality assessments of these tablets like assay, weight variation, hardness, friability, disintegration time were also determined and all these generic tablets passed compendial specifications. There were no significant differences (p < 0.05) in the percentage dissolution of drug from generic tablets at 15 minutes with the same from innovator brand tablet at the same time point. To compare the dissolution profiles of all the tablet formulations and the innovator brand, a model independent approach of difference factor (f1) and similarity factor (f2) was employed with all time-points included in the dissolution studies. These results indicated that all generic Doxycycline Hyclate tablets included in this investigation were bioequivalent with the chosen innovator brand and may be used interchangeably.