Biopharmaceutics Drug Disposition Classification System BDDCS

Recently, Wu and Benet (2005) have proposed classification of drugs that differs from the BCS classification system by using the major route of elimination rather than permeability as the criteria. The categories for BDDCS is as shown below:

BDDCS CLASS I BDDCS CLASS II

High solubility Low solubility

Extensive metabolism Extensive metabolism

BDDCS CLASS III BDDCS CLASS IV

High solubility Low solubility

Poor metabolism Poor metabolism

Wu and Benet (2005) propose that it is easier and less ambiguous to determine BDDCS assignments based on the extent of metabolism rather than BCS assignments using permeability (i.e., extent of absorption). Also, they propose that BDDCS will facilitate predictions and expand the number of class I drugs eligible for waiver of in vivo bioequivalence studies.

References

Chen JZ, Xie M, Bao L et al (2006) Characterization of rat stomach pH following famotidine and pentagastrin pre-treatment. AAPS J 8(S2): Abstract T2301

Davies B, Morris T (1993) Physiological parameters in laboratory animals and humans. Pharm Res 10:1093-1095 Lentz KA, Quitko M, Morgan DG et al (2007) Development and validation of a preclinical food effect model. J Pharm Sci 96:459-472 Lui CY, Amidon GL, Berardi RR et al (1986) Comparison of gastrointestinal pH in dogs and humans: implications on the use of the beagle dog as a model for oral absorption in humans. J Pharm Sci 75:271-274 Rowland M, Tozer TN (2011) Clinical pharmacokinetics and pharmacodynamics: concepts and applications. Wolters Kluwer/Lippincott Williams & Wilkins, Baltimore, MD Wu CY, Benet LZ (2005) Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a bio-pharmaceutics drug disposition classification system. Pharm Res 22:11-23

Additional Readings

Amidon GL, Lennernas H, Shah VP et al (1995) A theoretical basis for a biopharmaceutical drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 12:413-420 Ehrhardt C, Kim KJ (2008) Drug absorption studies: in situ, in vitro and in silico models. Springer Science and Business Media, LLC, New York, NY Gu C-H, Li H, Levons J et al (2007) Predicting effect of food on extent of drug absorption based on physicochemical properties. Pharm Res 24:1118-1130

Horter D, Dressman JB (2001) Influence of physicochemical properties on dissolution of drugs in the gastrointestinal tract. Adv Drug Deliv Rev 46:75-87

Sugano K, Okazaki A, Sugimoto S et al (2007) Solubility and dissolution profile in drug discovery. Drug Metab Pharmacokinet 22:225-254

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