Biopharmaceutics (BCS)

• What is the focus of biopharmaceutics?

  Oral drug delivery processes
• What is the first step in oral drug delivery?

  Dosage form disintegrates within stomach
• What does drug dissolution depend on?

  Solubility and dissolution

  
• What is required for drug absorption into circulation?

  Permeability through the gastrointestinal tract
• What does the company need to consider for new drug A capsule formulation?

  Drug properties and BCS guidelines
• When are in vivo bioequivalence studies necessary?

  If the drug has a narrow therapeutic range
• What is a danger of drugs with a narrow therapeutic range?

  Risk of toxicity and ineffective therapy
• What types of administration require bioequivalence studies?

  Buccal and sublingual administration
• What is the purpose of the Biopharmaceutics Classification System (BCS)?

  To provide guidelines on in-vitro testing
• What are the benefits of the BCS guidelines?

  Reduce costs and increase speed to market
• What are the classes of the Biopharmaceutics Classification System (BCS)?

  • Class I: High solubility, high permeability
  • Class II: Low solubility, high permeability
  • Class III: High solubility, low permeability
  • Class IV: Low solubility, low permeability

  
• What is a Biowaiver in the context of BCS?

  A waiver for in-vivo testing based on formulation
• What conditions must be met for BCS bio-waivers?

  Immediate-release solid oral dosage forms
• What defines a drug as highly soluble according to the FDA?

  Soluble in 250 ml of aqueous media
• What is the definition of rapidly dissolving in the BCS?

  At least 85% dissolves within 30 minutes
• What media are used to define rapid dissolution?

  0.1 N HCl, pH 4.5 buffer, pH 6.8 buffer
• How is permeability defined in the BCS?

  Based on the extent of absorption
• What does BCS allow for predicting absorption in humans?

  Non-human systems for in-vitro correlations
• What is the definition of a highly permeable drug?

  85% absorption in humans
• What methods can be used to measure intestinal permeability?

  In-vivo and in-vitro permeation studies
• What formulation strategies can BCS guide for drug candidates?

  • Class I: Soluble and absorbable drugs
  • Class II: Nanoparticles, salts, solid dispersions
  • Class III: Mucoadhesion, absorption enhancers
  • Class IV: Liquid filled capsules with enhancers