4/13/2019

Bcs Class I

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  • Whenever a new drug moiety is discovered, one of the 1st questions a pharmaceutical company asks is….whether or not the drug can be effectively administered by the oral route, for its intended use
    Biopharmaceutical Classification System (BCS) is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability
  • Biopharmaceutical Classification System (BCS) is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability
  • BCS was originally used to grant biowaivers for scale-up and post-approval changes for drug products, but was later extended to the approval of new generic products.
  • FDA suggests as a potential internal standard
  • (Determination in Caco II cells only applicable to passively absorbed substances)
  • A drug substance is considered “highly soluble” when the highest clinical dose strength is soluble in 250 mL or less of aqueous media over a pH range of 1–7.5 at 37 °C

  • when the dissolution rate is much greater than the gastric emptying, dissolution is not likely to be rate-limiting
  • BCS Can be used to obtain a biowaiver
  • It has been estimated that the application of BCS can result in annual savings of $35 million for
    the pharmaceutical industry
  • Reference: Particle size; Drug development services; Technical Brief 2011 Volume 9
    • Bcs
    College of Pharmacy, University of Michigan, Ann Arbor, Michigan 48109-1065, Department of Pharmacy and Technology, University of Valencia, Valencia, Spain, Faculty of Pharmaceutical Sciences, Setsunan University, Osaka, Japan, and Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857

    Abstract

    Orally administered, immediate-release (IR) drug products in the top 200 drug product lists from the United States (US), Great Britain (GB), Spain (ES), and Japan (JP) were provisionally classified based on the Biopharmaceutics Classification System (BCS). The provisional classification is based on the aqueous solubility of the drugs reported in readily available reference literature and a correlation of human intestinal membrane permeability for a set of 29 reference drugs with their calculated partition coefficients. Oral IR drug products constituted more that 50% of the top 200 drug products on all four lists, and ranged from 102 to 113 in number. Drugs with dose numbers less than or equal to unity are defined as high-solubility drugs. More than 50% of the oral IR drug products on each list were determined to be high-solubility drugs (55−59%). The provisional classification of permeability is based on correlations of the human intestinal permeabilities of 29 reference drugs with the calculated Log P or CLogP lipophilicity values for the uncharged chemical form. The Log P and CLogP estimates were linearly correlated (r2 = 0.79) for 187 drugs. Metoprolol was chosen as the reference compound for permeability and Log P or CLogP. A total of 62−69.0% and 56−60% of the drugs on the four lists exhibited CLogP and Log P estimates, respectively, greater than or equal to the corresponding metoprolol value and are provisionally classified as high-permeability drugs. We have compared the BCS classification in this study with the recently proposed BDDCS classification based on fraction dose metabolism. Although the two approaches are based on different in vivo processes, fraction dose metabolized and fraction dose absorbed are highly correlated and, while depending on the choice of reference drug for permeability classification, e.g., metoprolol vs cimetidine or atenolol, show excellent agreement in drug classification. In summary, more than 55% of the drug products were classified as high-solubility (Class 1 and Class 3) drugs in the four lists, suggesting that in vivo bioequivalence (BE) may be assured with a less expensive and more easily implemented in vitro dissolution test.

    Bcs Class Ii And Iv

    Keywords: BCS; solubility; dose number; permeability; partition coefficient; WHO essential drugs; top-selling US, European, Japanese drugs; BDDCS

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