Course

Practical: 3 Hrs./Week

1. Improvement of dissolution characteristics of slightly soluble drugs by some
2. Comparison of dissolution studies of two different marketed products of same
3. Influence of polymorphism on solubility and
4. Protein binding studies of a highly protein bound drug and poorly protein bound
5. Extent of plasma-protein binding studies on the same drug (i.e. highly and poorly protein bound drug) at different concentrations in respect of constant time.
6. Calculation of Ka, Ke, t1/2, Cmax, AUC, AUMC, MRT from blood profile data.
7. Calculation of bioavailability from urinary excretion data for two
8. Calculation of AUC and bioequivalence from the given data for two
9. In vitro absorption
10. Bioequivalency studies on the different drugs marketed e.g. Tetracycline, Sulphamethoxzole, Trimethoprim, Aspirin , on animals and human volunteers.
11. Absorption studies in animal inverted intestine using various
12. Effect on contact time on the plasma protein binding of
13. Studying metabolic pathways for different drugs based on elimination kinetics
14. Calculation of elimination half-life for different drugs by using urinary elimination data and blood level data.

This subject is designed to impart knowledge and skills of biopharmaceutics and pharmacokinetics and their applications in clinical practice, design of dose and dosage regimen and in solving the problems arised therein.Biopharmaceutics is the study of the relationship between the physicochemical properties of a drug, its formulation and route of drug administration on the behaviour of drug in the body. The principles underlying drug absorption, distribution, metabolism, excretion as well as factors influencing these processes are highlighted including use of AI. The course introduces Pharmacokinetics that deal with the quantitative study of drug movement within the body, by the understanding of pharmacokinetic parameters which aids in optimizing drug dosing and therapeutic efficacy. Dose calculation in special population such as obese, geriatrics, paediatric patients, pregnant and lactating mothers is also dealt in the course. The course also highlights the causes of pharmacokinetic variability in diseased conditions. The course enhances analytical and problem-solving abilities to interpret pharmacokinetic data. It also develops a patient-centered approach, encouraging critical thinking, problem solving and ethical practices in optimizing drug therapy and reducing adverse effects.

Upon successful completion of the course, the student shall be able to:

KNOWLEDGE

K1: Differentiate between biopharmaceutics, pharmacokinetics and pharmacodynamics K2: Outline the basic principles of biopharmaceutics and the use of AI to predict ADME K3: Describe the pharmacokinetics of drugs and its role in improving therapeutic outcomes K4: Explain bioavailability and bioequivalence and the design of BA/BE protocols.

K5: Calculate various pharmacokinetic parameters using compartment models in normal and diseased conditions.

K6: Employ the factors to be considered in dose calculation for Geriatrics, Paediatrics and obese population

SKILL

S1: Determine the order of reaction of the drug movement in the body using the given data S2: Estimate fraction of the administered dose (relative and absolute bioavailability) that enters systemic circulation

S3: Illustrate Compartment models (one and two) to give visual representation of drug disposition and rate process associated with it.

S4: Calculate pharmacokinetic parameters using the plasma concentration time profile

S5: Demonstrate metric measures conversions, milli-equivalent to milligram and vice versa S6: Calculate drug dosing in hepatic and renal failure

ATTITUDE

A1: Cooperate and work effectively in groups.

A2: Communicate effectively through presentations.

A3: Follow emerging trends in the field of pharmaceutical sciences

A4: Appreciate all the efforts to improve the knowledge

A5: Cultivate empathy and compassion.

A6: Embrace lifelong learning during professional development

TEXT BOOKS:

1. Gibaldi Biopharmaceutics and Clinical Pharmacokinetics, 4^theditionPharmaMed Press, Hyderabad, 2005

2.Shargel L and Yu AB, Applied biopharmaceutics and pharmacokinetics, 7^th edition McGraw Hill, 2016.

3. Brahmankar DM, JaiswalSB.Bio pharmaceutics and Pharmacokinetics-A Treatise, 3rd edn, VallabhPrakashan,Pitampura, Delhi, 2019.

REVIEW ARTICLE:

Sadybekov, A.V., Katritch, V. Computational approaches streamlining drug discovery. Nature 616, 673–685 (2023).

REFERENCE BOOKS:

1. Remington JP, Gennaro Remington’s Pharmaceutical Sciences, 18^th edition, Mack Publishing Company, Pennsylvnia, 1990.
2. Gibaldi M and Perrier Pharmacokinetics, 2nd edition, Marcel Dekker Inc., New York, 1982

RECOMMENDED JOURNALS:

1. European Journal of Pharmaceutics and Biopharmaceutics, Elsevier
2. Journal of Pharmacokinetics and Pharmacodynamics, Springer
3. Drug Metabolism and Pharmacokinetics,