Biopharmaceutics Classification System


Biopharmaceutics Classification System

The Biopharmaceutics Classification System is a guidance for predicting the intestinal drug absorption provided by the U.S. Food and Drug Administration [http://www.fda.gov/] . The fundamental basis for the BCS was established by Dr. Gordon Amidon who was presented with a Distinguished Science Award at the August 2006 International Pharmaceutical Federation (FIP) congress in Salvador, Brazil.Fact|date=February 2007

This system allows to restrict the prediction using the parameters solubility and intestinal permeability. The solubility classification is based on a United States Pharmacopoeia (USP) aperture. The intestinal permeability classification is based on a comparison to the intravenous injection. All those factors are highly important, since 85% of the most sold drugs in the USA and Europe are orally administered.

According to the Biopharmaceutics Classification System (BCS (disambiguation)), drug substances are classified as follows:

*Class I - High Permeability, High Solubility
** Example: Metoprolol
** Those compounds are well absorbed and their absorption rate is usually higher than excretion.
*Class II - High Permeability, Low Solubility
** Example: Glibenclamide
** The bioavailability of those products is limited by their solvation rate. A correlation between the in vivo bioavailability and the in vitro solvation can be found.
*Class III - Low Permeability, High Solubility
** Example: Cimetidine
** 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: Hydrochlorothiazide
** Those compounds have a poor bioavailability. Usually they are not well absorbed over the intestinal mucosa and a high variability is expected.

ee also

*ADME
**Partition coefficient
**Bioavailability
**Drug metabolism
**First pass effect
*Polar surface area

References

* H. Waterbeemd, H. Lennernäs, P. Artursson (editors), "Drug bioavailability: estimation of solubility, permeability, absorption and bioavailability", Wiley-VCH, Weinheim, Germany, 2003. ISBN 3-527-30438-X

External links

* [http://www.fda.gov/cder/OPS/BCS_guidance.htm BCS guidance] of the U.S. Food and Drug Administration


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