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Presentation biopharmaceutical classification system
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BIOPHARMACEUTICAL CLASSIFICATION SYSTEM
MD. TAJUL ISLAMROLL – 23
BATCH – 10TH
• 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.
Concept
• 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.
BCS
• Aqueous solubility-Solubility in aqueous solvent (H2O, water miscible solvents)
• Partition-co-efficient-Fatty solvent (water immiscible)
Solubility
• Drugs molecules pass the biological membrane by
-Active transport-Passive transport
Simple diffusion
Osmosis/ Pore transport
-Carrier mediated facilitated diffusion-Vesicular transport
PhagocytosisPinocytosis
Permeability
• 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.
Objects
Class Solubility Permeability
Class - 1 High High
Class – 2 Low High
Class – 3 High Low
Class - 4 Low Low
Classification
• Drugs dissolved rapidly• Drugs absorbed rapidly• Rapid therapeutic action• Excellent property• Ideal for oral route• Ex - Metoprolol
Class - 1
Class - 2• Drugs dissolve slowly• Drugs absorbed rapidly• Controlled released drugs• Oral / IV route for administration• Ex. Glibenclamide, Ezetimibe
Class - 3• Dissolved rapidly• Absorbance is limited• Incomplete bioavailability• Oral / IV route for administration• Ex. Cimetidine
Class - 4• Low dissolution rate• Low permeability property• Slow or low therapeutic action• IV or other routes are required• Ex. Hydrochlorothiazide
?THANKS