Biopharmaceutical classification system
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This document discusses biopharmaceutics, which is the study of how drugs are absorbed in the body. It describes the key properties of solubility and permeability that determine a drug's absorption. Drugs are classified into four categories based on whether they have high or low solubility and permeability. Drugs with both high solubility and permeability are absorbed rapidly, while those with low values in both properties are poorly absorbed and may require alternative routes of administration.
Biopharmaceutical classification system
- 2. • Drug is any substance that is capable of altering physiological activity. • Biopharmaceutics is the study of physical and chemical properties of drugs and their proper dosage relating onset, duration and integrity of drugs.
- 3. • They are on the basis of – Solubility – Permeability – Dissolution Solubility is the ability of the drugs to be solution after dissolution. Permeability of the drug to pass the biological membrane which is lipophilic.
- 4. • Aqueous solubility -Solubility in aqueous solvent (H2O, water miscible solvents) • Partition-co-efficient -Fatty solvent (water immiscible)
- 5. • Drugs molecules pass the biological membrane by -Active transport -Passive transport Simple diffusion Osmosis/ Pore transport -Carrier mediated facilitated diffusion -Vesicular transport Phagocytosis Pinocytosis
- 6. • To assess the relationship between in vitro dissolution characteristics and in vivo absorption performance of immediate-release (IR) products • To evaluate the feasibility and appropriateness of an extension of the biowaiver concept.
- 7. Class Solubility Permeability Class - 1 High High Class – 2 Low High Class – 3 High Low Class - 4 Low Low
- 8. • Drugs dissolved rapidly • Drugs absorbed rapidly • Rapid therapeutic action • Excellent property • Ideal for oral route • Ex - Metoprolol
- 9. • Drugs dissolve slowly • Drugs absorbed rapidly • Controlled released drugs • Oral / IV route for administration • Ex. Glibenclamide, Ezetimibe
- 10. • Dissolved rapidly • Absorbance is limited • Incomplete bioavailability • Oral / IV route for administration • Ex. Cimetidine
- 11. • Low dissolution rate • Low permeability property • Slow or low therapeutic action • IV or other routes are required • Ex. Hydrochlorothiazide