KING KHALID UNIVERSITY COLLEGE OF PHARMACY DEPARTMENT OF PHARMACEUTICS COURSE SPECIFICTION FOR PHARMACEUTICAL SCIENCES/PHARM-D

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1 KING KHALID UNIVERSITY COLLEGE OF PHARMACY DEPARTMENT OF PHARMACEUTICS COURSE SPECIFICTION FOR PHARMACEUTICAL SCIENCES/PHARM-D BY Mohammed Mahmoud Academic Session st Semester (Semester No 71) September January 2017

2 Course Specification Course Name Biopharmaceutics Course code PHT- 05 Section No: Credit hours (+0) Theory/week Program(s) in which the course is offered BACHELOR OF PHARMACEUTICAL SCIENCES, &PHARM D Programs College of Pharmacy Name of faculty member responsible for the course Name of faculty member responsible for the course (FEMALE SECTION) Lecture Timings Theory Dr. Ismail M.Mahmoud Phone Office: Mobile : Dr. Ismail M.Mahmoud Phone Office: Mobile Ph. Sunday, Tuesday, 9:00 am 10:00 am Thursday, 8.00 am 9: 00 am Lecture Timings Practical Level/year at which this course is offered Pre-requisites for this course (if any) Co-requisites for this course (if any) Location if not on main campus Total number of teaching weeks Total number of lectures Theory Total number of Practical Hours Not applicable Level 6 / Year PHT-202 Not Applicable 15 Weeks 45 Hours Not applicable Course Description This course provides a basic understanding of the principles of biopharmaceutics with a view for students to use this basic knowledge in understanding pharmacokinetics. A major focus in the understanding of how dosage form factors influence the drug bioavailability and pharmacological/toxicological actions THE MAIN LEARNING OUTCOMES FOR STUDENTS ENROLLED IN THE COURSE

3 Objectives Identify biopharmaceutics and its impact on patients treatment outcomes. Classify routes of drug administration and different dosage forms and understand their effect on drug bioavailability. Outline the complex and dynamic drug's journey in the body beginning by the processes of drug liberation from the dosage form ending by drug elimination from the body. Differentiate between pharcokinetics and pharmacodynamics. Classify pharmacokinetics parameters including absorption, distribution, metabolism and execretion(adme). Describe the mechanisms and factors involved in drug absorption. Understand the influence of different physicochemical, physiological and dosage form design on the drug bioavailability. Define certain definitions like, bioequivalents, pharmaceutical equivalents,drug generics, pharmaceutical alternatives and pharmacological alternatives. Outline and understand the use of in-vitro official methods as dissolution and in-vivo body fluid sampling in bioavailability and bioequivalent studies. Record,tabulate, draw and calculate different pharmacokinetic experimental data to interpret different drug kinetic orders. Evaluate bioequivalence and bioavailability parameters involved to attain the most safe and TEXT BOOK FOR REFERENCE SCHEDULE OF ASSESSMENT TASKS Quiz -I Exam 10marks

4 Mid Term Theory Exam Quizes Assignments Final Exam Total 0 Marks 10 Marks 10 Marks 50 Marks 100 Marks Examination protocol Quiz-I Quiz-I will consist 20 multiple choice questions for 10 marks Topics for Quiz-I Topics covered to date Date for Quiz- Examinations will be announced through Black Board as per the agreement with group Leader MID-TERM EXAM Mention the pattern of exam and type of questions for Midterm Topics for Mid-term exam Topics covered to date 20% of questions will be writing

5 FOR MID TERM EXAMINATION, DATE, TIME AND PLACE OF EXAMINATION WILL BE INFORMED BY ACADEMIC OFFICE Assignments through E-Learning Activity It will be given individually to the students from the topics of the course to do some online activities in the black board (E-assignments, Discussion Board and Forums) it will carry 10 marks END SEMSTER EXAM Final exam will consist of 80 multiple choice questions for 50 marks. Duration of the examination is 2 Hour 15 minutes FOR END SEMESTER EXAMINATION, DATE, TIME AND PLACE OF EXAMINATION WILL BE INFORMED BY ACADEMIC OFFICE

6 TEACHING SCHEDULE FOR Theory Topics to be Covered week List of Topics No. of Lecturer lectures 1 Introduction to biopharmaceutics. Concepts and definitions; biopharmaceutics, bioavailability, pharmacokinetics. LADME (liberation, absorption, distribution, metabolism and excretion) system. Nature of cell membranes 2 2. Drug passage across membranes Transport mechanisms Factors affecting passive diffusion; concentration gradient, partition coefficient, degree of ionization. Fick s law and pressure diffusion. ph-partition theory. Active transport. Facilitated diffusion. Vesicular transport. Ion-pair formation. Combined absorption model.

7 &4 -Gastrointestinal absorption of drugs o Physicochemical factors affecting drug absorption from GIT. o Rate-limiting steps in drug absorption. o Factors affecting drug dissolution rate in the GIT; Physiological factors; viscosity of GIT fluids, degree of agitation, volume of GIT fluids, rate of absorption Physicochemical factors affecting drug dissolution in the GIT o Effect of particle size. o Solid dispersions. o Crystal form. o Salt form. o Complexation. 6 5-Dosage form factors influencing drug absorption from the gastrointestinal tract Influence of excipients; diluents, surfactants, viscosity enhancing agents Influence of the type of dose form

8 7 6-In-vitro dissolution testing o Noyes Whitney equation. o Official methods of dissolution Bioequivalence criteria Bioequivalence parameters Bio and Pharmaceutical equivalence Pharmaceutical alternatives Generics Pharmacological equivalence Pharmaceutical alternatives 9&10 8-Drug distribution and protein binding. Body compartments modelling schematic representations different models: Physiological factors affecting drug distribution. Body fluids, diffusion and hydrostatic pressure. Tissue perfusion and initial drug distribution. Drug accumulation, permeability of cell and capillary membranes, Apparent volume of distribution and plasma drug-protein binding 6

9 11 & 12 9 Drug Elimination a-drug metabolism Biotransformation Different phases of drug metabolism First pass effect Enzymes involved in drug metabolism Hepatic elimination of drugs; enzyme kinetics, kinetics of enzyme inhibition. Factors affecting biotransformation. Enzyme Induction Enzyme inhibition Prodrugs 6 1& Dug excretion Drug excretion Renal excretion of drugs; anatomic consideration of the kidney, glomerular filtration, active renal secretion, tubular re-absorption. Mechanisms of clearance and ph dependency Hepatic secretion. Intestinal, pulmonary, salivary excretion. Excretion into mammary and sweat glands. Factors affecting excretion 6

10 15 11-Rates and order of kinetic parameters Zero order kinetics of drug disposition Fist order kinetics of drug disposition Calculating rate of drug elimination and t1/2