Bioequivalence and Bioavailability Forum

Dear Govardhan,

If your drug is a BCS class III so the permeability is the limitant factor for absorption. Some authors^1-3 have concluded that differences in dissolution rates observed earlier than 30 min have negligible consequences in vivo for BCS class III drugs. Moreover, you should evalute if excipients may influence either the permeability or solubility of the drug. Therefore, I should ensure if your formulation is BCS class III too.

Considering the issue about IVIVC for formulations with BCS class III drugs generally is possible to establish a nonlinear IVIV relationship. This relationship might ensure that your formulation has a BCS class III behaviour (http://www.dissolutiontech.com/DTresour/800Articles/800_art1.html) but this model is not applied to predict the in vivo disposition of the formulation.

Best regards,

Daniel Rossi de Campos

1. Polli JE. 1997. In vitro-in vivo relationships of several "immediate" release tablets containing a low permeability drug. Adv Exp Med Biol 423:191-
   198.
   
2. Cheng CL, Yu LX, Lee HL, Yang CY, Lue CS, Chou CH. 2004. Biowaiver extension potential to BCS Class III high solubility-low permeability drugs: Bridging evidence for metformin immediaterelease tablet. Eur J Pharm Sci 22:297-304.
   
3. Blume HH, Schug BS. 1999. The biopharmaceutics classification system (BCS): Class III drugs - Better candidates for BA/BE waiver? Eur J Pharm Sci 9:117-121.