PHARMACEUTICS-X(BIO PHARMACEUTICS & PHARMACEUTICS) PY-702
Introduction to biopharmaceutics & pharmacokinetics development and their role in drug formulation.
Bio pharmaceutics:
Definition,passage of drugs across biological barrier,Physio-chemical,Biological and Pharmaceutical factors influencing biopharmaceutical performance of drugs.
Bio pharmaceutics:
Definition,passage of drugs across biological barrier,Physio-chemical,Biological and Pharmaceutical factors influencing biopharmaceutical performance of drugs.
- 1.Gastrointestinal absorption of drugs: Passage of drugs across biological membranes, nature of biological membranes, gastrointestinal absorption mechanisms.
- 2. Factors affecting drug absorption : Physiological factors, dietary factors,physiochemical factors, pH partition hypothesis, dosage form factors.
- 3. Methods of studying gastrointestinal absorption: In vitro and in vivo methods.
- 4. Drug disposition: Distribution in blood, cellular distribution, plasma protein binding, tissue protein binding.Drug Excretion: Routes of drug excretion, renal excretion of drugs, factors affecting renal excretion, biliary and salivary excretion of drugs. Drug biotransformation: Pathways of drug metabolism, drug metabolizing enzymes, factors affecting drug metabolism and drug response, inhibition and stimulation of drug metabolism.
Pharmacokinetics
Absorbtion, distribution metabolism and excretion of drugs, fluid compartment and circulatory system, protein binding, significance of plasma drug concentration measurement.
Absorbtion, distribution metabolism and excretion of drugs, fluid compartment and circulatory system, protein binding, significance of plasma drug concentration measurement.
Compartment Models
Model selection criteria,alaika information criterian,one – compartment and two compartment models,
Wagner- Nelson and loo Riegelman methods for estimation of absorption constants. Curve fittings,regression procedure and area under blood level curves.
Clinical Pharmacokinetics:
Urinary excretions, computation of pharmacokinetic parameters from urine data, haepetic clearance,biliary excretion,excretion ratio,dosage regimen adjustment in patients with and without renal failure,pharmacokinetic drug interaction and their significance in combination therapy.
Urinary excretions, computation of pharmacokinetic parameters from urine data, haepetic clearance,biliary excretion,excretion ratio,dosage regimen adjustment in patients with and without renal failure,pharmacokinetic drug interaction and their significance in combination therapy.
Biovailability and Bioequivalance:
Biovailability and Bio-equivalance,Federal requirements,Methods of determination of bio- availability using blood level and urinary excretion data, design and evaluations, bioavailability assessment.
BOOKS RECOMMENDED :
- Gibaldi, M.and Perrier d, Pharmacokinetics, 4th edn. Pharma mid press, Hydrabad
- Notari, R.E., Biopharmaceutics and pharmacokinetics-An Introduction, marcel Decker New York.
- Jaiswal , Brahmankar Biopharmaquality and pharmacokinetics.
- Leepeter I.D., Pharmacokinetic analysis
- Niazi Textbook of Biopharmacokinetics and clinical pharmacokinetics.
- Venkaateshwaru v , Biopharmaceutics and pharmacokinetics, phared puss, Hydrabad.
- Wagner-pharmacokinetics for the pharmastudies.
- Dhachinamoorthi D: Biopharmaceutics and pharmacokinetics : A practical mannd
- Shargel : pharmacokinetics & Biopharmacokinetics & Biopharmaceutics
- Determine the percentage protein binding of the given drug.
- Determine oral bioavailability of the given drug/formulation by urinary excretion method using animal model.
- Perform bioequivalence study of two different brands of the marketed tablets of the given drug using animal model.
- Determine the rate of in-vitro absorption of the given drug using everted intestinal sack.
- Determine the effect of different pH condition on solubility of a weekly acidic or basic drug and study PH partition hypothesis.
- Establish IVIVC for the given sample of drug.
- Calculate elimination rate constant and elimination half life of given excretion data by sigma minus method.
- Calculate elimination rate constant and elimination half life of the given drug data administered by i.v. bolus injection represented by one compartment model.
- Calculate various pharmacokinetic parameters from the given data generated after single extra vascular administration of drug represented by one compartment model.
- Calculate various pharmacokinetic parameters from the given data obtained by using two compartment open model.
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