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AKTU Biopharmaceutics and Pharmacokinetics (Theory) (BP602T) Syllabus PDF – B.Pharm 6th Semester
Biopharmaceutics and Pharmacokinetics (Theory) BP602T
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Official AKTU syllabus of Biopharmaceutics and Pharmacokinetics (Theory) (BP602T) for B.Pharm 6th Semester – 3 credits, L-T-P 3-0-0. Read the unit-wise course content, course outcomes, evaluation pattern and recommended books online, or download the PDF.
Syllabus — Biopharmaceutics and Pharmacokinetics (Theory)
Download PDFBP602T · 3 credits · L-T-P 3-0-0
Course Objectives
- Describe fundamental biopharmaceutics and pharmacokinetic principles governing drug absorption, distribution, metabolism, and excretion.
- Analyze the physicochemical and biological factors that determine drug bioavailability, protein binding, and elimination pathways.
- Illustrate compartmental pharmacokinetic models, and their evaluations through application of mathematical equations to calculate key parameters.
- Design, conduct, and interpret bioavailability, bioequivalence, and in vitro in vivo correlation studies.
- Apply pharmacokinetic principles to optimize dosing regimens including loading and maintenance doses and steady-state kinetics and utilize software tools to analyze both linear and non-linear drug kinetics.
Course Outcomes
| CO | Upon successful completion of this course, the students will be able to |
| No. | |
| 1 | Interpret fundamental pharmacokinetic and pharmacodynamic principles and apply them to patient-centered clinical scenarios. |
| 2 | Evaluate the impact of physicochemical and biological variables on drug absorption, distribution, and protein binding in clinical practice. |
| 3 | Differentiate among bioavailability classifications and develop bioequivalence study protocols that comply with international regulatory standards. |
| 4 | Solve pharmacokinetic problems using compartment models by employing numerical techniques |
| 5 | Design optimal dosing regimens, interpret non-linear pharmacokinetic behaviors, and utilize simulation software for PK/PD analysis. |
Course Content
| Unit | Topics | No. of |
|---|---|---|
| I | Introduction to Biopharmaceutics and pharmacokinetics: Introduction to various Pharmacokinetic parameters (using Plasma drug Concentration vs Time curve) and Pharmacodynamic parameters and drug delivery index. Absorption; Mechanisms of drug absorption through GIT, Physicochemical, Biological and Dosage form related factors influencing drug absorption though GIT, methods of Assessment of GIT absorption, Distribution Tissue permeability of drugs, binding 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. | 10 hours |
| II | Elimination (Metabolism and Elimination): Drug metabolism and basic understanding of metabolic pathways renal excretion of drugs, factors affecting renal excretion of drugs, renal clearance, non renal routes of drug excretion of drugs Bioavailability and Bioequivalence: Definition and Objectives of bioavailability, absolute and relative bioavailability, Introduction to BCS and biopharmaceutical drug disposition classification system, methods of measurement of bioavailability (Plasma data, Urinary excretion data), Protocol for assessment of bioavailability and bioequivalence studies. in-vitro drug dissolution methods (test apparatus I-VII), biorelevant dissolution mediums, in-vitro in-vivo correlations: Concept and Applications, Biowaivers, Methods of enhancement of bioavailability. | 10 hours |
| III | Pharmacokinetic Models: Compartment Models: Definition, Basis of classification, Properties of compartment, Advantages and disadvantages of compartment modelling. Kinetic considerations of One compartment open model. (a). Intravenous Injection (Bolus/rapid) (b). Intravenous infusion and (c) Extra-vascular administration. (with emphasis on Curve Fitting, Wagner Nelson, Loo Riegelman) Introduction to non - compartment model: Principles, estimation of PK parameters (AUC, AUMC, MRT, MAT statistical moment theory). | 10 hours |
| IV | Multicompartment models: Multiple dosage regimen: dosing interval, drug accumulation, loading dose, maintenance dose, PK Parameters Kinetic consideration of two compartment open model (a) Intravenous Injection (Bolus/rapid) and (b) Extra vascular administrations (oral administration). Kinetics of multiple dosing, steady state drug levels, calculation of loading and maintenance doses and their clinical significance. Multiple dosage regimen. Introduction to pharmacokinetic consideration of Modified release drug products. | 9 hours |
| V | Nonlinear Pharmacokinetics: Introduction, Reasons for Non-linearity, Michaelis-menton method of estimating parameters, Explanation with example of drugs. Application of PK software: Introduction of various in -silico methods for calculating various PK parameters. | 6 hours |
Recommended References
- Shargel, L. and Yu, A. B. C. Applied Biopharmaceutics and Pharmacokinetics. McGraw-Hill Education.
- Gibaldi, M. Biopharmaceutics and Clinical Pharmacokinetics. Lea & Febiger.
- Rowland, M. and Tozer, T. N. Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications. Wolters Kluwer.
- Bonate, P. L. Pharmacokinetic-Pharmacodynamic Modeling and Simulation. Springer.
- Brahmankar, D. M. and Jaiswal, S. B. Biopharmaceutics and Pharmacokinetics: A Treatise. Vallabh Prakashan.
- Eddy, D. M. Modeling and Simulation in the Medical and Health Sciences. Springer.
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