Biopharmaceutics

Course Code:

PHAR 414

Course Period:

Spring

Course Type:

Core

P:

2

Lab:

0

Credits:

2

ECTS:

3

Course Language:

English

Course Coordinator:

Çetin TAŞ

Courses given by:

Gülengül DUMAN

Course Objectives:

The major focus in biopharmaceutics will be concentrated on the various in vitro and in vivo factors that can affect drug performance in the body during the processes of liberation, absorption, distribution, metabolism and excretion of drug. The personalized medicine enhance healthcare by selecting treatments that are more efficient drug response or induce less adverse responses

Course Content:

Define the relative biopharmaceutic terminology, Identify all biologic, physiologic, and pathologic factors, which influence drugs’

absorption, disposition ant response in the body, Understand how physical and chemical drugs’ properties, dosage form and route of

administration can influence drug performance in the body.

Understand how those factors may affect drugs’ levels needed to reach site of action

Course Methodology:

1: Lecture, 2: Question-Answer, 3: Discussion, 4: Presentation, 5:Simulation, 6: Video, 7: Applications, 8:Case Study

Course Evaluation Methods:

A:Written exam, B: multiple chose , C:Filing the blank D:False and troth, E: Oral Exam F: Portfolio, G: Contrabution of course activities H:Homework

Vertical Tabs

Course Learning Outcomes

Learning Outcomes	Programme learning outcomes	Teaching Methods	Assessment Methods
Understand the requirements of the course, the routes of drug administration; Intravenous, intramuscular, subcutaneous, intraarterial, intraspinal, transdermal nasal and ocular routes. Discuss the advantages and limitation of each route of administration of drugs	1,2,3,4,5,6,7,8,9,10,11,12,13,14	1,2,3,4,5,6,7,8	A,B,C,D,E,F,G,H
Adequate knowledge in the requirements for performing bioequivalence studies; design, reference standard, evaluation of the data (analytical method, pharmacokinetic parameters, and statistical evaluation).	9,10,11,12,13,14	1,2,3,4,5,6,7,8	A,B,C,D,E,F,G,H
Personalized medicine and biopharmaceutics, Improvement studies of ‘Drug Delivery Systems’	1,2,3,4,5,6,7,8	1,2,3,4,5,6,7,8	A,B,C,D,E,F,G,H

Course Flow

COURSE CONTENT
Week	Topics	Study Materials
1	Introduction to Biopharmaceutics and its applications Relationship and relevance of course to dosage form design, general overview of course contents, expectations. Description of the assessment system and marks distribution. Physiological & physicochemical factors affecting absorption	Textbook, Course notes,
2	Definitions of commonly used terms biopharmaceutics and pharmacokinetics, absorption, distribution, metabolism, excretion. Overall scheme for pharmacokinetics of drugs.	Textbook, Course notes,
3	Physiological factors affecting drug absorption Membrane physiology and examples for some membranes, e.g. blood brain barrier, renal tubules. Transport mechanisms across membranes; carrier and non carrier mediated transport, vesicular transport and ion-pair mechanisms. Factors affecting each type of drug transport mechanism along examples of drugs will be discussed.	Textbook, Course notes,
4	Biopharmaceutic consideration of dosage forms Physicochemical properties of the drugs affecting absorption; solubility, partition coefficient, particle size, polymorphs,and excipients. Formulation effect on drug absorption; solutions, suspensions, tablets, capsules and modified-release dosage forms. Testing methods of different dosage forms and relevance to evaluation of product characteristics, e.g. disintegration, dissolution, particle size analysis, etc.	Textbook, Course notes,
5	Site specific drug delivery systems (DDS) General concepts and reasons for using such products. Rationale of using new drug delivery systems; drug properties, biopharmaceutical related parameters for drug performance, pharmacokinetics- and clinical-related factors. General requirements for drug delivery systems.	Textbook, Course notes,
6	Novel Drug delivery systems and Improvements studies and biopharmaceutics	Textbook, Course notes,
7	Presentations	Textbook, Course notes,
8	Liposomes as Drug Delivery systems (DDS), properties and advantages. Formulation of liposomal DDS, factors affecting half-life of the liposomes (particle size and mode of administration). DDS; properties, effect of site of administration on drug targeting, particle size & surface characteristics and its effect on drug targeting life.	Textbook, Course notes, Videos
9	Absorption from gastrointestinal tract (GIT) Factors affecting gastrointestinal absorption; gastric emptying, motility, enzymes and pH. First-pass effect and its influence on drug efficiency. Effect of diseases on absorption of orally administered drugs. Advantages and limitation of absorption by enteral routes other than oral; buccal, rectal.	Textbook, Course notes,
10	Midterm	Textbook, Course notes,
11	Absorption from different route of administration Characteristics and Advantages & limitation of different routes for administration of drugs; Intravenous, intramuscular, subcutaneous, intraarterial, intraspinal, oral, rectal, buccal, transdermal nasal and ocular routes.	Textbook, Course notes,
12	Personalized medicine and biopharmaceutics	Textbook, Course notes,
13	Bioavailability and bioequivalence Definition of bioavailability, relative bioavailability, pharmaceutical equivalents and bio-equivalents, therapeutic equivalents and substitutes.	Textbook, Course notes,
14	Bioequivalence studies of dosage forms and method of determination. Regulatory status governing the products required for bioequivalence testing.	Textbook, Course notes,
15	Presentations	Textbook, Course notes,

Recommended Sources

Textbook	Ansel, H.C., Pharmaceutical dosage forms and drug delivery systems. Lea and Febiger, Philadelphia
Additional Resources	Video, Notes

Material Sharing

Documents	Course Notes, Textbook
Assignments	Projects and Presentations
Exams	Midterms (I)

Assessment

IN-TERM STUDIES	NUMBER	PERCENTAGE
Midterm Exam	1	50
Presentation	1	50
Total		100
CONTRIBUTION OF FINAL EXAMINATION TO OVERALL GRADE		60
CONTRIBUTION OF IN-TERM STUDIES TO OVERALL GRADE		40
Total		100

COURSE CATEGORY

√Compulsary/Elective

Course’s Contribution to Program

COURSE'S CONTRIBUTION TO PROGRAM
No	Program Learning Outcomes	Contribution
No	Program Learning Outcomes	1	2	3	4	5
1	Has national and international up-to-date, theoretical and applied knowledge in the field of pharmacy.				√
2	Defines problems related to the profession, collects data, evaluates its accuracy and reliability, develops evidence-based solutions, shares them with healthcare professionals, makes necessary explanations to other people.				√
3	Communicates accurately and effectively in accordance with cultural and ethical values with all relevant professional groups, especially those working in the field of health, and all segments of society, using information and communication technologies.				√
4	Takes into account the rules of law and ethics in subjects concerning public health.				√
5	Acts as a pharmacist with high career awareness, self-confidence, leadership spirit, who is prone to teamwork, entrepreneurial, productive and able to manage financial resources.				√
6	Acts as an easily accessible health consultant with a patient-oriented approach by centering the principle of pharmaceutical care and plays an active role in constantly informing the society.			√
7	Improves his/her knowledge by participating in in-service training and activities in line with the needs of the century and society, takes part in the professional development of colleagues and adopts the lifelong learning principle.				√
8	Suggests and manages multidisciplinary / interdisciplinary research and development projects related to pharmaceuticals, cosmetics, medical devices and shares their results.			√
9	Applies knowledge and skills for the benefits of society by taking part in social responsibility projects.			√
10	Fulfills the requirements of quality management systems while using the theoretical and applied knowledge acquired in the field.			√

ECTS

Activities	Quantity	Duration (Hour)	Total Workload (Hour)
Course Duration (Including the exam week: 16x Total course hours)	16	2	32
Hours for off-the-classroom study (Pre-study, practice)	16	1	16
Midterm Exam	1	6	5
Homework	1	6	6
Final	1	6	6
Total Work Load			65
Total Work Load / 25 (h)			2,6
ECTS Credit of the Course			3

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