Transcript Biopharmaceutics Considerations in Drug Product

Dr. Muslim Suardi, MSi., Apt.
Faculty of Pharmacy, University of Andalas
Biopharmaceutics
The study of the relationship of the physicochemical
characteristics and in vitro behavior of the drug and
drug product on the delivery of the drug to the body
under normal or pathologic conditions.
Biopharmaceutics Considerations
in Drug Product Design
 Pharmacodynamic considerations
 Drug considerations
 Drug product considerations
 Patient considerations
 Manufacturing considerations
Pharmacodynamic Considerations
- Therapeutic objective
- Toxic effects
- Adverse reactions
Drug Considerations
Chemical & physical properties of drug
 pKa & pH profile
 Particle size
 Polymorphism
 Hygroscopicity
 Partition coefficient
 Excipient interaction
 pH stability profile
 Solubility
Drug Product Consideration
 Pharmacokinetics of drug
 BA of drug
 RoA
 Desired dose of drug
 Dosing frequency
Patient Consideration
 Compliance & acceptability of drug product
 Cost
Manufacturing Considerations
 Cost
 Availability of raw materials
 Stability
 QC