1. Bcs Class 2 Drug List

Contents • • • • • • BCS classes [ ] According to the Biopharmaceutical Classification System (BCS) drug substances are classified to four classes upon their solubility and permeability: • Class I - high, high • Example: • Those compounds are well absorbed and their absorption rate is usually higher than excretion. • Class II - high permeability, low solubility • Example:,,,, • The of those products is limited by their solvation rate.

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Bcs Class 2 Drug List

Absorptive Flux (J). “If two drug products, containing the same drug. BCS Classification. P e rme a bility.

A correlation between the bioavailability and the solvation can be found. • Class III - low permeability, high solubility • Example: • The absorption is limited by the permeation rate but the drug is solvated very fast. If the formulation does not change the permeability or gastro-intestinal duration time, then class I criteria can be applied. • Class IV - low permeability, low solubility • Example: • Those compounds have a poor bioavailability. Usually they are not well absorbed over the intestinal mucosa and a high variability is expected. Definitions [ ] The drugs are classified in BCS on the basis of solubility, permeability, and dissolution. Solubility class boundaries are based on the highest dose strength of an immediate release product.

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. 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. 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. Alternatively non-human systems capable of predicting drug absorption in humans can be used (such as in-vitro culture methods). Ni mate crack.