![]() Permeability class boundaries are based indirectly on the extent of absorption of a drug substance in humans and directly on the measurement of rates of mass transfer across human intestinal membrane. The volume estimate of 250 ml is derived from typical bioequivalence study protocols that prescribe administration of a drug product to fasting human volunteers with a glass of water. A drug is considered highly soluble when the highest dose strength is soluble in 250 ml or less of aqueous media over the pH range of 1 to 7.5. Solubility class boundaries are based on the highest dose strength of an immediate release product. The drugs are classified in BCS on the basis of solubility, permeability, and dissolution. Usually they are not well absorbed over the intestinal mucosa and a high variability is expected.
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