Bioequivalence and Bioavailability Forum

Hi everyone
In oral pharmaceutical formulations, combinations of methylparaben and propylparaben are applied with concentrations generally ranging from 0.015 to 0.2% for methylparaben and 0.02% to 0.06% for propylparaben.

Due to possible endocrine-disrupting effects in humans parabenes are no longer allowed for use as a food additive within the European Union and in pharmaceutical preparations wherever possible the use of parabens should be avoided, particularly in case of paediatric formulations and/or the concentration used should be at the lowest feasible level according to the reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use EMA/CHMP/SWP/272921/2012.

Does by chance anybody know if for a generic test formulation a difference in the content of parabens in comparison to an oral liquid reference formulation could have an influence on bioavailability/bioequivalence of a drug?

I am looking forward to your replies and a fruitful discussion.
Kind regards
Dr_Dan