Faculty : Pharmacy Department: Pharmaceutical Sciences and Pharmaceutics Academic Year: Semester : Second ( Course Syllabus )

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1 APPLIED SCIENCE PRIVATE UNIVERSITY (A.S.U) AMMAN - JORDAN جامعة العلوم التطبيقية الخاصة ( ج.ع.ت( عمان األردن فلنجعل من أردن العرب جامعة للعرب Faculty : Pharmacy Department: Pharmaceutical Sciences and Pharmaceutics Academic Year: Semester : Second ( Course Syllabus ) Subject Name Credit Hours Course No. Prerequisite Concurrent course Biopharmaceutics Coordinator Name Lecturer/s Room No. Course website Office Hours o/index.jsp Ahmad Aljaberi, Ph.D. Ahmad Aljaberi, Ph.D. 205 aljaberi@asu. edu.jo Sun: Mon:11-1 Tues: Wed: 11-1 Course Description: This course introduces students to the concepts of Biopharmaceutics including the processes of absorption, distribution, metabolism, and excretion of drugs. The basic principles and concepts of biopharmaceutics that affect the absorption and distribution of drugs in the body will be discussed. This course will also cover the routes of administration and effect of the physicochemical properties of drugs and drug products on the bioavailability of these drugs. In addition, diffusion and drug release following drug administration will constitute a major part of the course. The ability to communicate effectively the physicochemical properties of the drug product and the relevant physiology leading to the optimization of drug delivery by any route of administration will be emphasized. Course objective: This course aims to establish the terminology, fundamental concepts, and principals of biopharmaceutics that determine the drug release and absorption of different drug products after administration via various routes. Intended Learning Outcomes: Following the successful completion of this course, the student should be able to: A. Knowledge and understanding: A1. Understand the basic concepts of biopharmaceutics as well as their role in pharmaceutical drug development. A2. Understand the rule of partition coefficient during preformulation studies in the development of pharmaceutical dosage forms. A3. Describe diffusion principles such as Fick's laws of diffusion and permeability, and the application of such principles in drug transport through various barriers and absorption. 1

2 A4. Recognize drug release and dissolution basics with emphasis on methods and apparatus for measuring dissolution of solid dosage forms, methods for improving dissolution of medicinal substances, and its rule in the biopharmaceutical classification system. A5. Define various terms related to bioavailability and bioequivalence. B. Subject specific skills: B1. Identify the physiological, physicochemical and dosage form-related factors that affects drug absorption from different dosage forms. B2. Appreciate the food effect on the absorption and the subsequent therapeutic outcome of an orally administered drug. B3. Recognize the role of the biopharmaceutical classification system in developing generic drug product from therapeutic equivalence point of view. C. Cognetive and Intellectual skills: C1. Identify patient factors which require a modification of the regular posology and administration of prescribed drugs. C2. Qualitatively and quantitatively determine the physicochemical properties of active pharmaceutical ingredient that may propose a challenge for drug product development. C3. Evaluate and predict the effect of dosage form type and formulation on drug release and the subsequent therapeutic response. D. Transferable Skills: D1. Consult patients about the proper way to administer oral drugs based on sound biopharmaceutical justification. D2. Trouble shoot for issues that may arise during generic drug development at industrial level Teaching and Learning Methods: Development of ILOs is promoted through the following teaching and learning methods: ILOs Learning Methods Evaluation Methods A1 A5 Lectures (to explain the theoretical B1 B3 knowledge for each topic) C1 and D1 Case discussion: to apply the knowledge to predict drug absorption in real life situations (e.g. food, disease, and other drugs effects on drug absorption and therapeutic outcome) C2, C3, and D2 Case discussion: to apply the knowledge to predict drug absorption for different drugs that have different physicochemical properties, formulation, and route of administration Multiple choice exams Multiple choice exams Multiple choice exams 2

3 Course Content: Week Date Lecture number Topic s Details Introduction and distribution phenomenon Ionization and ionization constants of drugs, Lipophilicity, distribution phenomenon, the partition coeffiect Diffusion Definitions, Thermodynamic Basis of Diffusion, Diffusion Driving Forces, Fick s Laws of Diffusion, sink condition, Permeability, Multilayer Diffusion, Zero and first order release FIRST EXAM Drug release and dissolution Dissolution, the Noyes-Whitney model, Factors affecting the dissolution rate, Dissolution and Release from Oral Drug Products, Dissolution Methods and Apparatus Transport of Drugs Across Biological Membranes Biological membranes and drug transport, Transport Mechanisms, Membrane Structure and Composition, Permeability and the ph partition hypothesis, Problems in the quantitative application of the ph partition hypothesis SECOND EXAM Increasing the Permeability and Absorption of Drugs The Biopharmaceutical Classification System, Predicting low drug absorption, Barriers to drug absorption, Strategies to overcome the barriers to drug absorption The gastrointestinal tract - physiology and drug absorption Physiological factors influencing oral drug absorption, Physiology of the gastrointestinal tract, The transit of Pharmaceuticals in the gastrointestinal tract Exams/ quizes/ holidays Main Reference (chapter) ILOs achieved 9 (Ref-A1) A1, A2 11 (Ref-A1) A3 13 (Ref-A1) 14 (Ref-B1) A4, C3 11 (Ref-A1) 9 (Ref-B2) A2, B1 11 (Ref-A1) 9 (Ref-B2) B3, C2 19 (Ref-A2) B1, B2, C1, D1 3

4 Bioavailability - physicochemical and dosage form factors Physicochemical factors influencing bioavailability, Dosage form factors influencing bioavailability, Influence of the type of dosage form, Influence of excipients for conventional dosage forms Assessment of biopharmaceutical properties Measurement of key biopharmaceutical properties, Stability in physiological fluids, Assessment of bioavailability, Absolute and relative bioavailability FINAL EXAM 20 (Ref-A2) 21 (Ref-A2) C2, C3, D2 A1, A5 Grade Distribution: Your course grade will be determined by the following: Assessment Method % of Final Grade Due Date - First Exam 25 * - Second Exam 25 * - Final Exam 50 * * Exam dates will scheduled by the examination committee according to the university calendar. Distribution of examination material (may vary depending on material included): Example: 35% - Introduction and distribution phenomenon, diffusion principles 35% - Drug release and dissolution, Transport of Drugs Across Biological Membranes 30% - Increasing the Permeability and Absorption of Drugs, The gastrointestinal tract - physiology and drug absorption, Bioavailability - physicochemical and dosage form factors, Assessment of biopharmaceutical properties. 23. Course Policies: A- Attendance policies: Attendance: Mandatory. First warning with 4 absences Last warning with 5 absences Failing in the subject with 6 absences B- Absences from exams and handing in assignments on time: Will result in zero achievement unless health report or other significant excuse is documented. C- Health and safety procedures: NA D- Honesty policy regarding cheating, plagiarism, misbehavior: The participation, the commitment of cheating will lead to applying all following penalties together 1. Failing the subject he/she cheated at 4

5 2. Failing the other subjects taken in the same course 3. Not allowed to register for the next semester. The summer semester is not considered as a semester E- Grading policy: Exams and Quizzes. First Exam: Second exam: Projects (Quiz/assignment): Final Exam: Total: 25 points 25 points N/A 50 points 100 points F- Available university services that support achievement in the course: Classrooms 24. Required equipment: Computers, data show and internet connection Make-up Exam Policy: Make-up exams will be offered for valid reasons. They may be different from regular exams, both in content and format. References: A- Required book (s), assigned reading and audio-visuals: 1- Martin s Physical Pharmacy and Pharmaceutical Sciences. Patrick J. Sinko. Sixth Edition, Aulton's Pharmaceutics: The Design and Manufacture of Medicines. Michael E. Aulton and Kevin M.G. Taylor. Fourth edition B- Recommended books, materials, and media: 1- Applied Biopharmaceutics & Pharmacokinetics. Leon Shargel, Susanna Wu-Pong, and Andrew Yu. Sixth edition, Physicochemical Principles of Pharmacy. Alexander. T. Florence and Dvaid Attwood. Fifth Edition, Additional information: No side talks during lecture No mobile phones during lecture Entering the lecture theatre after the instructor is not permitted. Homework should be done by students independently and will be asked at the exams 5

6 Course Material and Announcements Students need to use the e-learning page at the ASU website in order to get all lecture hand-outs and guidelines which will be uploaded there. In addition, course related announcements and exam results will be posted on the ASU online AND/OR course website and is the responsibility of each student to check the sites regularly. Name of Course Coordinator: Head of curriculum committee: Head of Department: Dean: Signature: Date: Signature: Signature: Signature: Copy to: Head of Department Head of curriculum committee Course File C 26 / version 3 Date: رقم اجراء الخطة الدراسية 6