Bioequivalence and Bioavailability Forum

Dear Dr Dan,

❝ Since the formulation of a drug could influence the extend of sublingual absorptions and as you pointed out in your last sentence sublingual absorption is not always 100%

Agreed that SL absorption is not always 100%. But if we are in the debate of whether to consider emesis criteria for SL formulation, important thing is not SL absorption but oral bioavailability

(e.g. Say we are administrating 100mg SL tablet of Drug X and 80mg is going into GIT (20mg enters into systemic circulation via SL route) but oral bioavailability is 1%, then amount of drug entering from GIT (except SL) in systemic circulation will be 0.8 mg which will hardly matter when compared to 20mg which is absorbed Sublingually. In this case emesis criteria will not help pharmacokinetically and lead to loss of data).

I just wanted to confirm whether keeping emesis criteria for SL formulations solemly based on fraction of dose getting GI absorbed is scientifically correct and accepted by developed regulatories or not???

Regards,
Hiren