Reduced Syllabus for M.

Pharm - Semester II (2024-25)

M. Pharm. Sem II (Pharmaceutics)
CBCS (R-2019)

MPH202T Advanced Biopharmaceutics & Pharmacokinetics

Chapter Description Time Proposed

and unit teaching
time
1 Drug Absorption from the Gastrointestinal Tract 12 10

1.1 The gastrointestinal tract, Mechanism of drug 3 3

absorption, Factors affecting drug absorption, pH– partition
theory of drug absorption (covered in UG)
1.2 Formulation and physicochemical factors: Dissolution rate, 4 4
Dissolution process, Noyes– Whitney equation and drug
dissolution, Factors affecting the dissolution rate

1.3 Gastrointestinal absorption: role of the dosage form: 1 0

Solution (elixir, syrup, and solution) as a
dosage form, Suspension as a dosage form, Capsule as a
dosage form, Tablet as a dosage form
1.4 Dissolution methods, Formulation and processing factors, 2 1.5
Correlation of in vivo data with in vitro
dissolution data
1.5 Transport model: Permeability-Solubility-Charge State 2 1.5
and the pH Partition Hypothesis,
Properties of the Gastrointestinal Tract (GIT), pH
Microclimate Intracellular pH Environment,
Tight-Junction Complex
2 Biopharmaceutic considerations in drug 12 8
product design and In Vitro Drug Product
Performance
2.1 Introduction, biopharmaceutic factors affecting drug 2 0
bioavailability, rate-limiting steps in drug absorption, (Covered in
physicochemical nature of the drug formulation factors chapter 1)
affecting drug product
performance
2.2 In vitro dissolution and drug release testing, 7 6
compendial methods of dissolution, alternative
methods of dissolution testing, meeting dissolution
requirements, problems of variable control in dissolution
testing performance of drug
products
2.3 In vitro–in vivo correlation, dissolution profile 3 2
comparisons, drug product stability, considerations in the
design of a drug product
3 Pharmacokinetics 12 12
3.1 Basic considerations, pharmacokinetic models, 2 2
compartment modeling
 Reduced Syllabus for M. Pharm - Semester II (2024-25)
M. Pharm. Sem II (Pharmaceutics)
CBCS (R-2019)

3.2 One compartment open model – IV bolus, IV 5 5

infusion, and EV
3.3 Multi-compartment model: two-compartment - model in 1 1
brief
3.4 Non-linear pharmacokinetics: cause of non- 2 2
linearity, Michaelis – Menten equation, estimation of
kmax and Vmax
3.5 Drug interactions: introduction, the effect of protein- 2 2
binding interactions, the effect of tissue- binding
interactions, cytochrome P450-based drug interactions,
drug interactions linked to transporters.
4 Drug Product Performance, In vivo: Bioavailability and 12 10
Bioequivalence
4.1 Drug product performance, purpose of 1 1
bioavailability studies, relative and absolute availability

4.2 Methods for assessing bioavailability, bioequivalence 4 3

studies, design and evaluation of bioequivalence studies,
study designs, crossover study designs, evaluation of the
data, bioequivalence example, study submission, and drug
review process
4.3 Biopharmaceutics Classification System, methods 2 2
4.4 Permeability: In-vitro, in-situ and In-vivo methods 2 2
4.5 Generic biologics (biosimilar drug products), the clinical 3 2
significance of bioequivalence studies,
special concerns in bioavailability and bioequivalence
studies, generic substitution
5 Application of Pharmacokinetics 12 8
5.1 Modified-Release Drug Products, Targeted Drug 3 3
Delivery Systems, and Biotechnological Products
5.2 Introduction to Pharmacokinetics and 3 2
pharmacodynamic drug interactions
5.3 Pharmacokinetics and pharmacodynamics of biotechnology 3 3
drugs
5.4 Introduction, Proteins and peptides, Monoclonal antibodies, 3 0
Oligonucleotides, Vaccines
(immunotherapy), Gene therapies
TOTAL 60 48

Note:

1. Topics in red are for self-study and no questions to be asked on them.

2. Topics highlighted in yellow are not to be covered in that chapter as they are being
covered elsewhere in the syllabus
3. Numerical to be asked on one compartment open model – iv bolus and ev ONLY
(Highlighted in green)