Presentation 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