The BCS classification categorizes drugs based on their solubility and permeability, which influence absorption and bioavailability. It helps in designing formulations and regulatory strategies.
Classification of Biopharmaceutics:
Class | Solubility | Permeability | Examples |
I | High | High | Metoprolol, Propranolol |
II | Low | High | Ibuprofen, Ketoprofen |
III | High | Low | Cimetidine, Ranitidine |
IV | Low | Low | Furosemide, Hydrochlorothiazide |
Significance of BCS:
Guides Formulation Strategies:
Class I: Focus on stability rather than solubility or permeability issues.
Class II: Enhance solubility through particle size reduction, salt formation, or solid dispersions.
Class III: Focus on permeability enhancers.
Class IV: Complex approaches involving both solubility and permeability enhancement.
Waiver of Bioequivalence Studies (Biowaivers):
BCS Class I drugs can receive biowaivers, simplifying generic drug development.
Improves Drug Delivery Systems:
Focuses on enhancing solubility and permeability during formulation.