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. Definitions [ ] The drugs are classified in BCS on the basis of solubility, permeability, and dissolution. 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. Solubility class boundaries are based on the highest dose strength of an immediate release product. Usually they are not well absorbed over the intestinal mucosa and a high variability is expected.

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