BCS and IVIVC Based Biowaivers

This work was to suggest the biowaiver potential of biopharmaceutical classification system (BCS) Class II drugs in self-microemulsifying drug delivery systems (SMEDDS) which are known to increase the solubility, dissolution and oral absorption of water-insoluble drugs. Cyclosporine was selected as a representative BCS Class II drug. New generic candidate of cyclosporine SMEDDS (test) was applied for the study with brand SMEDDS (reference I) and cyclosporine self-emulsifying drug delivery systems (SEDDS, reference II). Solubility and dissolution of cyclosporine from SMEDDS were critically enhanced, which were the similar behaviors with BCS class I drug

  • BCS biowaivers
  • Preclinical and clinical testing for oral drug delivery
  • Waiver for In vivo Bioavailability or Bioequivalence
  • Consideration of Biowaiver extensions for BCS class III drugs
  • In vitro diffusion cells for dissolution testing in formulation development
  • Dissolution testing in drug formulation
  • In vitro preclinical ADME/BCS testing
  • In vitro drug product research
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