Applied Biopharmaceutics and Pharmacokinetics Detailed Syllabus for Pharmaceutics / Pharmaceutical Technology M.Pharm first year first sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course.
The detailed syllabus for Applied Biopharmaceutics and Pharmacokinetics M.Pharm 2017-2018 (R17) first year first sem is as follows.
M.Pharm. I Year I Sem.
Course Objective: The student shall learn about bioavailability, bioequivalence and factor affecting bioavailability. They also learn the pharmacokinetic parameter like drug disposition, absorption, nonlinear and time dependant pharmacokinetics. They also understand about the drug interactions & problems, practice associated in pharmacokinetic parameters calculations.
Course Outcome: students will be able to express factors affecting the bioavailability and stability of dosage form; they also learn the bioequivalence studies and protocols for bioequivalent studies. They also evaluate the parameters for the disposition, absorption and Michaelis-Menton constants for nonlinear kinetics.
UNIT – I
- Biological and metabolic factors affecting bioavailability, complexation, dissolution – techniques of enhancing dissolution.
- Formulation factors affecting bioavailability of drugs in dosage forms of tablets, capsules, parenterals, liquid orals and topical dosage forms.
- Bioavailability: Importance, dose dependency, AUC, rate and extent, assessment, blood and urine samples, single dose and multiple dose studies, Invitro Invivo Correlation analysis and Levels of Correlations.
- Bioequivalence: Importance equivalency concepts, biowaivers, study designs, protocol, transformation of data, Statistical Criteria as per the Regulations.
UNIT – II : Pharmacokinetics – Drug Disposition: compartment models: One, two and non-compartmental approaches to pharmacokinetics. Recent trends, merits and limitations of these approaches. Application of these models to determine the various pharmacokinetic parameters pertaining to:
- Distribution: Apparent volume of distribution and its determination. factors affecting.
- Metabolism: Metabolic rate constant, Factors affecting Metabolism
- Elimination: Over all apparent elimination rate constant, and half life.
- All the above under the following conditions:
- Intravenous infusion
- Multiple dose injections
- Noninvasive methods of estimating pharmacokinetics parameters with emphasis on salivary and urinary samples.
- Concept of clearance: organ, total clearance, hepatic clearance, lung clearance and renal clearance.
UNIT – III : Pharmacokinetics – Absorption: Rate constants – Zero order, first order, Models of experimental study of absorption (in silico, in vitro, in situ and in vivo) – Absorption half lives, method of residuals, Wagner – Nelson method, Loo – Reigleman method, Analysis of kinetics from urine samples. Pharmacokinetic parameters determination pertaining to: Multiple dosage oral administration
UNIT – IV : Non-linear pharmacokinetics: Concepts of linear and non-linear pharmacokinetics, Michaelis Menton kinetics characteristics. Basic kinetic parameters, possible causes of non-induction, nonlinear binding, and non-linearity of pharmacological responses.
Clinical Pharmacokinetics: Altered kinetics in pregnancy, child birth, infants and geriatrics. kinetics in GI disease, malabsorption syndrome, liver, cardiac, renal and pulmonary disease states.
UNIT – V : Time dependent pharmacokinetics: Introduction, classification, physiologically induced time dependency: Chronopharmacokinetics – principles, drugs– (amino glycosides, NSAIDS, antihypertensive drug) chemically induced dependency.
Drug Interactions: Kinetics of drug interaction, study of drug-drug interaction mediated through absorption, distribution, metabolism and elimination, mechanisms of interaction and consequence. Numerical problems associated with all units, if any.
TEXT BOOKS:
- Biopharmaceutics and Clinical Pharmacokinetics by MiloGibaldi.
- Learn Shargel and ABC yu, Applied Biopharmacokinetics and
- Biopharmaceutics and Pharmacokinetics by C.V.S. Subrahmanyam, Vallabh Prakashan. 2010.
- Basic biopharmaceutics, Sulnil S. Jambhekar and Philip J Brean.
- Text book of Biopharmaceutics and Clinical Pharmacokinetics by Niazi Sarfaraz
RECOMMENDED BOOKS:
- Bio-Pharmaceutics and Pharmacokinetics by V. Venkateshwarlu.
- Pharmacokinetics. Biopharmaceutics and Clinical pharmacy by Robert E. Notari.
- Biopharmaceutics and Clinical Pharmacokinetics – An Introduction by Robert E. Notari.
- Drug drug interactions, scientific and regulatory perspectives by Alber P. G
For all other M.Pharm 1st Year 1st Sem syllabus go to JNTUH M.Pharm Pharmaceutics / Pharmaceutical Technology 1st Year 1st Sem Course Structure for (R17) Batch.
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