Biopharmaceutics & Pharmacokinetics (2 hrs Lecture+1 hr Practical)

  • College of Pharmacy |

Description

The course is concerned with the exploration and examination of the physicochemical properties of drugs in the physiological environment and their impact on product performance in vitro and in vivo. It explores the principles of biopharmaceutics and strategies for enhancing drug delivery and bioavailability in addition to specialized knowledge essential to understand the concept of bioequivalence. Also, it introduces the students to basic pharmacokinetic parameters and mathematical aspects. General principles of pharmacokinetic models are presented as they pertain to the process of absorption, distribution and elimination of drugs in humans and the significance of these processes in drug therapy. Topics also emphasize linear and nonlinear metabolic clearance kinetics, drug-drug interaction mechanisms and kinetics, in vitro-in vivo predictions, pharmacogenetics and other sources of inter-individual variability.

Program

Bachelor of Pharmacy - PharmD

Objectives

  • 1.1 Define different pharmacokinetic parameters including: clearance, apparent volume of distribution, elimination rate constant, and elimination half-life.

    1.2 Define different steps involved in drug dissolution in gut lumen, absorption, distribution and elimination.

    1.3 Recognize the various pharmacokinetic parameters that can be obtained following single and multiple intravenous and oral drug administration doses

    1.4 Define and differentiate between pharmacokinetics of non-potent drugs and narrow therapeutic index drugs.

    2.1 Interpret plasma concentration- time profiles following administration of drugs via different administration routes.

    2.2 Gain the mathematical skills for necessary calculations of different pharmacokinetic parameters.

    2.3 Interpret effect of formulation additives on in-vitro drug release profile and in-vivo performance of the drug product.

    3.1 Calculate the elimination half-life, elimination rate constant, absorption rate constant, apparent volume of distribution, and total body clearance from the plasma concentrations-time curve following administration of drug using different routes of administration.

    3.2 Determine the diffusion rate, dissolution rate and effect of acidity or alkalinity on drug ionization and solubility.

    3.3 Estimate the oral bioavailability of drugs from plasma concentration-time profile of drugs.

    4.4 Develop effective communication skills.

    3.5 Analyze different factors affecting drug absorption, distribution, metabolism and excretion from GIT.

    4.1 Gain problem solving skills related to pharmacokinetic parameters estimation.

    4.2 Extend information gained to understand pharmacokinetic aspects of different drug administration routes.

    4.3 Work individually to present the required tasks with effective time management skills.

    3.4 Applying problem solving skills and critical thinking to reach proper pharmaceutical decisions as dose initiation, maintenance and modification.

Textbook

Basic Pharmacokinetics. Author: Mohsen A. Hedaya. 2nd edition (2012). Publisher: CRC Press.

Course Content

content serial Description
1Introduction to biopharmaceutics and pharmacokinetics. (Lecture)
1Introduction to pharmacokinetic mathematical concepts.(Practical)
2Basic pharmacokinetics terminology, rate and orders of processes. (Lecture)
2Graphical representation of data. (Practical)
3Pharmacokinetic parameters following single I.V. bolus drug administration using plasma data (Part I). (Lecture)
3Practice problems to calculate pharmacokinetic parameters following I.V bolus administration of a single dose using plasma data (Part I). (Practical)
4Pharmacokinetic parameters following single I.V. bolus drug administration using plasma data (Part II). (Lecture)
4Practice problems to calculate pharmacokinetic parameters following I.V bolus administration of a single dose using plasma data (Part II). (Practical)
5Pharmacokinetic parameters following constant rate I.V. infusion drug administration using plasma data (Part I). (Lecture)
5Practice problems to calculate pharmacokinetic parameters following I.V infusion administration using plasma data. (Practical)
6Pharmacokinetic parameters following constant rate I.V. infusion drug administration using plasma data (Part II).(Lecture)
6Practice problems to calculate pharmacokinetic parameters following extravascular single dose administration using plasma data (Part I). (Practical)
7Pharmacokinetic parameters following single oral dose using plasma data (Part I).(Lecture)
7Practice problems to calculate pharmacokinetic parameters following extravascular single dose administration using plasma data (Part II). (Practical)
8Pharmacokinetic parameters following single oral dose using plasma data (Part II). (Lecture)
8Theoretical background related to dissolution rate of solids. (Practical)
9Pharmacokinetic parameters following multiple dose using plasma data.(Lecture)
9Practice problems to calculate dissolution rate of solids. (Practical)
10Physiological factors affecting drug absorption: membrane physiology. (Lecture)
10Practice problems about effect of pH on ionization and absorption. (Practical)
11Physiological factors affecting drug absorption: mechanisms of drug transport. (Lecture)
11Practice problems about effect of pH on solubility and precipitation.(Practical)
12Physiological factors affecting drug absorption: GIT characteristics. (Lecture)
12Practice problems related to partition coefficient of drugs. (Practical)
13Physico-chemical factors affecting oral drug absorption. (Lecture)
13Theoretical background related to drug permeability across the skin. (Practical)
14Formulation factors affecting oral drug absorption. (Lecture)
14Practice problems related to drug permeability kinetics across the skin. (Practical)
15Bioavailability and Bioequivalence. (Lecture)
15Effect of excipients on in-vitro drug release from semisolid dosage forms. (Practical)

Markets and Career

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