Table 3b.

Proposed relevant bioperformance dissolution methodology (apparatus and media).

BCS sub-classification	Gastric medium	Consider gastric compartment?	Intestinal luminal medium	Consider absorption compartment?a
I	250 ml PGBe	Nob	900 ml PIBc	No
IIa		Yesd	100 ml PIB	Yes
IIb		Yesd	100 ml PIB	Yes
IIc		Yesd	100 ml PIB + bile acids/lipid	Yes
III		Nob	100 ml PIB	No
IVa		Yesd	100 ml PIB	Yes
IVb		Yesd	100 ml PIB	Yes
IVc		Yesd	100 ml PIB + bile acids/lipid	Yes

^aAn organic medium (such as 1-octanol) can be used for the absorption compartment when logD_pH6.5 > than about 0.5–1 (Mudie et al., 2012). Otherwise, an alternative such as an artificial or caco2 membrane (Kataoka et al., 2003, 2006, 2012, 2013) may be used. Surface area of organic medium (or membrane) to volume ratio of luminal medium (A/V) must be chosen properly (Mudie et al., 2012).

^bPretreat dosage form with gastric medium for 15 min and subsequently transfer dosage form + gastric medium to intestinal luminal medium. Determine contribution of gastric emptying rate to delay in onset of appearance in plasma computationally.

^cPhysiological intestinal buffer (PIB), which should be pH 6.5 bicarbonate buffer with a buffer concentration between about 5–15 mM, or an aqueous buffer with an equivalent buffer capacity.

^dEmpty gastric contents in a first order manner with a rate coefficient of 2.8 h⁻¹ (half-emptying time of 15 min).

^ePhysiological gastric buffer (PGB), which is 0.01 N HCl.