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Effect of enantiomerism on the bioequivalence of a new ibuprofen 600‐mg tablet formulation obtained by roller compaction
Author(s) -
Matji Antonio,
Vargas Emilio,
Carvajal Luis,
Terleira Ana Isabel,
Portolés Antonio,
GarciaArieta Alfredo,
Torrado Juan J.,
Serrano Dolores R.
Publication year - 2020
Publication title -
chirality
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.43
H-Index - 77
eISSN - 1520-636X
pISSN - 0899-0042
DOI - 10.1002/chir.23148
Subject(s) - bioequivalence , ibuprofen , cmax , chemistry , enantiomer , crossover study , chromatography , pharmacology , pharmacokinetics , stereochemistry , medicine , alternative medicine , pathology , placebo
The bioequivalence of a new ibuprofen 600‐mg film‐coated tablet obtained by roller compaction was studied in a crossover study with 22 healthy volunteers. Bioequivalence was analyzed based on (a) the S ‐enantiomer, (b) the R ‐enantiomer, and (c) the sum of both enantiomers (representing the results of an achiral assay). The bioequivalence conclusion for ibuprofen products should be based not only on AUC and Cmax but also on tmax since tmax is related to the onset of action. However, it is not possible to ensure if bioequivalence has been demonstrated for tmax as regulators have not defined the acceptance range for the difference between medians of tmax in those cases, where tmax is clinically relevant. In this study, it was possible to conclude bioequivalence for tmax based on S ‐ibuprofen, though this conclusion might be questioned if the decision is based on R ‐ibuprofen or the achiral method.