Syllabus
Unit 1
Drug Absorption: 15 hrs
A) Overview of oral absorption 5hr:
Rate limiting steps in drug absorption. Mechanism of drug absorption Determinants of the fraction of the dose absorbed.
B) Skin Absorption pathways 2 hr: Transport across intact stratum corneum,Permeability
C) Drug absorption in the lung 2 hrs: Factors affecting drug absorption and disposition.
D) Oral mucosal absorption 2 hr: Mechanism involved in oral mucosal absorption
E) Nasal Drug absorption 2 hrs: Factors affecting nasal absorption. Transport route of nasal epithelial barrier. Relevance of blood brain barrier.
F) Transcorneal drug absorption into the eye 2 hrs: General routes and physicochemical properties
Unit 2
Biopharmaceutic considerations in drug product design and Invitro Drug Product Performance (8 hrs)
· Biopharmaceutical factors affecting drug bioavailability, factors affecting drug product performance. (3hrs)
· Noyes Whitney equation: Meeting dissolution requirements Dissolution profile Comparisons.Pharmacodynamic considerations in the design of drug product and drug product stability.(3hrs)
· In vitro–in vivo correlation.(2hrs)
Unit 3
: Pharmacokinetics10 hrs
· Pharmacokinetics of an IV bolus injection in One Compartment Model: Basic pharmacokinetic equations. Duration of action
· Pharmacokinetics of an IV bolus injection in Two Compartment Model: Basic pharmacokinetic equations.
· Pharmacokinetics of Intravenous Infusion: Basic pharmacokinetic equation and its applications .Steady State plasma concentration and factors controlling Steady State plasma concentration. Loading dose.
· Pharmacokinetics of Extravascular administration: Basic pharmacokinetic equations to derive PK parameters. Absorption Lag time, Flip-Flop mode l
Non Compartmental Analysis: Benefits over Compartmental Analysis.Mean residence Time,applications.
Unit IV Drug Product Performance In Vivo: Bioavailability and Bioequivalence
· Bioequivalence studies,Design and evaluation of bioequivalence studies, study designs, crossover study designs, evaluation of the data, bioequivalence example,study submission and drug review process.,
· Clinical significance of bioequivalence studies, special concerns in bioavailability and bioequivalence studies, generic substitution. Biowaivers,Generic biologics (biosimilar drug products).
Unit 4
Application of Pharmacokinetics
· Pharmacokinetics and pharmacodynamics of novel drug delivery Systems
Modified-Release Drug Products, Targeted Drug Delivery Systems
· Pharmacokinetics and pharmacodynamics of
Biotechnological Products
Introduction, Proteins and peptides and Monoclonal antibodies, Oligonucleotides, Vaccines(immunotherapy), Gene therapies
Scope
This course is designed to impart knowledge and skills necessary to relate the physicochemical properties of the drug in a dosage form, physiological conditions and formulation related factors with the drug product performance. It also emphasizes on the study of theories related to drug dissolution and requirements of dissolution testing. It also gives an overview of distribution and elimination stages of the drug which can impact drug perfrormance. It provides an insight into the different types of metabolism based drug interactions linked to transporters.
The subject discusses on basic theoretical principles of pharmacokinetics and pharmacokinetic models to understand the concepts and to apply the in practical problem-solving. The course deals with in vivo performance of drug product as well as bioavailability and bioequivalence studies which is crucial in ensuring the safety and efficacy of pharmaceutical products. It also gives information about the PK-PD of novel drug delivery systems, biotechnological products and imaging of dosage forms.
Objectives and Outcomes
Upon successful completion of the course, the student shall be able to;
KNOWLEDGE
K1: Discuss the principles of drug absorption by various routes.
K2: Apply the biopharmaceutic considerations in dosage form design.
K3: Assess the factors affecting drug absorption.
K4: Elaborate bioavailability and bioequivalence methods and protocol
K5: Illustrate the applications of pharmacokinetic equations K6: Examine the PK PD of novel and biotechnological products SKILL
S1: Evaluate the diffusion coefficient of drugs
S2: Identify the effect of protein binding of drugs
S3: Determine the kinetics of the drug movement in the body
S4: Estimate the pharmacokinetic parameters for drug following compartment models.
S5: Examine the types of pharmacokinetic models and kinetics
S6: Assess the absorption mechanism of drugs in the body.
ATTITUDE
A1: Follow responsible learning attitude
A2: Communicate effectively
A3: Appreciate emerging trends to improve knowledge
A4: Cultivate critical thinking
A5: Foster adaptability
A6: Exhibit professionalism.
