A comparative in vitro dissolution study of generic moxifloxacin immediate-release film coated tablets and referent pharmaceutical product

Abstract

Dissolution testing of generic immediate release solid dosage forms represents a valuable tool to obtain dissolution profiles and to establish the similarity/dissimilarity between tested dosage forms. In this study, the in vitro dissolution profiles of generic immediate-release moxifloxacin (MOX) film coated tablets and a referent pharmaceutical product were compared and evaluated. The dissolution behavior of the generic product was investigated in three different dissolution media (pH=1.2, 4.5 and 6.8). The amount of dissolved MOX was determined using validated UV spectrophotometric method. For comparison of the dissolution behavior, the similarity factor, f2, was used. The dissolution profile of the generic product showed a release of >85 % MOX in the time frame of 30 min, in all the tested dissolution media. The similarity factor, f2, calculated from the comparison of the dissolution profiles of the generic and the referent pharmaceutical product in pH=1.2 dissolution medium was 50, 58, thus the products were established as similar. Based on the results of our study, the dissolution similarity between the generic MOX immediate-release film coated tablet and the referent product could be successfully used as a part of the approach to ensure their in vivo bioequivalence. Keywords: moxifloxacin, immediate-release solid dosage forms, dissolution, in vitro similarity

Therapeutic Equivalence Evaluated Through In Vitro Studies of Multi-Source Drugs: A Moxifloxacin Case Study in Lima, Peru

“…A study carried out in Pakistan in 2019 evaluated four different brands of multi-source moxifloxacin tablets (400 mg), finding f2 values of 77.20, 69.56, 76.98, and 82.17 respectively, which indicated that there was similarity in the release profile of the four brands compared to the reference brand (10). An investigation carried out in Macedonia in 2018, evaluated a generic drug of moxifloxacin tablets (400 mg), determining the f2 value of 50.85 at pH 1.2, concluding that the similarity of dissolution in vitro could be used as an important part of the approach to ensure bioequivalence in vivo and therapeutic equivalence (11).…”