SVKM’s Narsee Monjee Institute of Management Studies

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, Mumbai

School of Pharmacy & Technology Management, Shirpur
School of Pharmacy & Technology Management, Hyderabad

Program: B. Pharm. Semester : VI

Course : Biopharmaceutics and Pharmacokinetics - Theory Code: BP 604 T

Teaching Scheme Evaluation Scheme

Lecture Practical Term End

Tutorial Internal Continuous
(Hours (Hours Examinations (TEE)
(Hours Credit Assessment (ICA)
per per (Marks- 75
per week) (Marks - 25)
week) week) in Question Paper)
3 0 1 4 Marks Scaled to 25 Marks Scaled to 75
Pre-requisite: Knowledge of mathematics, pharmaceutics, dosage form design, human anatomy
and physiology

Scope: This subject is designed to impart knowledge and skills of biopharmaceutics and
pharmacokinetics and their applications in pharmaceutical development, design of dose and
dosage regimen and in solving the problems raised therein.

Objectives: This course will provide an understanding of biopharmaceutical aspects and

pharmacokinetic parameters along with practical applications.

Outcomes:
After completion of the course, students would be able to :
1. Explain absorption, drug disposition and protein binding mechanism for the drug & predict
its Pharmacokinetics.
2. Understand physicochemical, pharmaceutical and patient related parameters, and correlate
this knowledge to the ADME of drug and differentiate the processes in linear and nonlinear
type.
3. Explain compartment models and Compute pharmacokinetic parameters form given data.
4. Design BABE study for given formulation based on data given.

Detailed Syllabus: ( per session plan )

Unit Description Duration

in hours
1. Introduction to Biopharmaceutics : 10
Absorption, Mechanisms of drug absorption through GIT, factors influencing
drug absorption through GIT, absorption of drug from Non per oral extra-
vascular routes, distribution, factors affecting drug distribution (Tissue
permeability of drugs), apparent volume of drug distribution, plasma and
tissue protein binding of drugs, factors affecting protein-drug binding.
Kinetics of protein binding, clinical significance of protein binding of drugs.

2. Elimination: Drug metabolism and basic understanding metabolic pathways 8

renal excretion of drugs, hepatic clearance and extraction ratio, relation of
 SVKM’s Narsee Monjee Institute of Management Studies
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, Mumbai
School of Pharmacy & Technology Management, Shirpur
School of Pharmacy & Technology Management, Hyderabad

bioavailability with clearance, factors affecting renal excretion of drugs, renal

clearance, non-renal routes of drug excretion of drugs.
3. Pharmacokinetics: Definition and introduction to pharmacokinetics, 12
compartment models, non-compartment models, physiological models, one
compartment open model.
(a) Intravenous Injection (Bolus), (b) Intravenous infusion and (c) Extra
vascular administrations. Pharmacokinetics parameters -Ke, t 1/2, Vd, AUC, Ka,
ClT and ClR- definitions methods of eliminations, understanding of their
significance, derivation of PK parameters and hands on PK data analysis using
one compartment model.
4. Multicompetent models: Two compartment open model. IV bolus 4
Kinetics of multiple dosing, steady state drug levels, calculation of loading and
maintenance doses and their significance in clinical settings.
5. Nonlinear Pharmacokinetics: Introduction, Factors causing Non-linearity, 11
Michaelis-Menten method of estimating parameters, Explanation with
example of drugs.
Bioavailability and Bioequivalence:
Definition and Objectives of bioavailability, calculation of absolute and relative
bioavailability, measurement of bioavailability, in-vitro drug dissolution
models, in-vitro-in-vivo correlations, bioequivalence studies, design of parallel
and cross-over BE study, estimation of AUC for BE calculation using MS Excel,
methods to enhance the dissolution rates and bioavailability of poorly soluble
drugs.

6. Tutorials 15
Total 60
Text Books:
1. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi, 4th edition, 2011 (Reprint),
PharmaMed Press, Hyderabad, India.
2. Biopharmaceutics and Clinical Pharmacokinetics-An introduction, by Rebort F Notari 4th
Edition, 2017, Revised and expanded, Marcel Dekker Inn, New York and Basel.
3. Applied biopharmaceutics and pharmacokinetics, By Leon Shargel and Andrew B.C.YU, 8th
edition, 2022, McGraw Hill, LLC, USA
4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil
B.Jaiswal, 3rd edition, 2019 (Reprint),Vallabh Prakashan, Pitampura, Delhi

Reference Books:
1. Pharmacokinetics, By Milo Glbaldi & Donald Perrier, 2nd Edition, 2013 (e Book), Mercel
Dekker Inc., USA.
2. Biopharmaceutics and Clinical Pharmacokinetics An Introduction, By Notari, 4th Edition,
1986, Marcel-Dekker Inc., USA
 SVKM’s Narsee Monjee Institute of Management Studies
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, Mumbai
School of Pharmacy & Technology Management, Shirpur
School of Pharmacy & Technology Management, Hyderabad

Any other information:

Total Marks of Internal Continuous Assessment (ICA) : 25 Marks

Distribution of ICA Marks :

Description of ICA Marks
Sessional Examination 15
Term Work 10
Total Marks : 25

Saritha Shetty
____________ ____________
Signature Signature
(Prepared by) (Approved by)
Dr. Saritha Shetty Dr. Bala Prabhakar
Section Head- Pharmaceutics Dean, SPPSPTM