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Course Code: 
PHAR 414
Course Period: 
Spring
Course Type: 
Core
P: 
2
Lab: 
0
Credits: 
2
ECTS: 
3
Course Language: 
English
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, excretion and achievement therapeutic of response. İlacın etki bölgesine ulşma hızı ve miktarına bu faktörlerin etkisinin anlaşılması
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

  1. 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

  1. 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

  1. 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

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

Presentatations

Textbook, Course notes,

8

Liposomes as DDS, properties and advantages. Formulation of liposomal DDS, factors affecting half-life of the liposomes (particle size and mode of administration). Microparticles as 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

 2

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

No

Program Learning Outcomes

Contribution

1

2

3

4

5

1

Acquire skills needed to practice the profession of pharmacy in either a Turkish or an English language setting.

 

 

 

 

2

Being equipped to access current theoretical and applied knowledge, keeping abreast of new developments, and possessing the critical faculties enabling an accurate and reliable interpretation and assessment of this information.

 

 

 

 

3

Having the capacity to apply the skills acquired in the field of pharmaceutical science. Possessing the ability to harness his/her acquired knowledge in order to function as a highly accessible health counsellor, providing a ready source of clinically relevant, health-related information to the general public.

 

 

 

 

4

Keeping abreast of and being equipped to apply the fundamental pharmaceutical and health science principles which guide future developments in modern technology, and being able to share these experiences and skills with colleagues through participatation in professional development education seminars.

 

 

 

 

5

Knowing how to assess risks arising from the use of drugs and other chemicals and those risks potentially encounterd during laboratory practice.

 

 

 

 

6

Acquiring the skills and knowledge needed to interpret findings obtained through quantative and qualitative measurements, and thus reach valid, scientific conclusions based on this data. 

 

 

 

 

7

Being able to compound pharmaceutical products while being knowledgable about their clinical application, interactions, side effects and risks  and apply in proper manner .

 

 

 

 

8

Being competent to conduct and manage research and development projects, and share experimental outcomes.

 

 

 

 

9

Be competent to accurately and intelligibly communicate clincally relevant information to patients concerning prescription items and other pharmaceutical products.  

 

 

 

 

10

Being able to function in a multidisciplinary environment. Possessing the skill to collaborate and establish lines of communication with other professionals, while developing their own professional competency through participation in relevant continuing education activities.

 

 

 

 

11

Being able to play a role in projects which fulfills the profession’s societal responsibilities. Participating in professional activities and undertaking duties in a manner which reflects an awareness of and sensitivity to environmental issues.

 

 

 

 

12

Being capable of opening a community pharmacy, practicing in a hospital pharmacy setting, and offering service in any field related to drugs, cosmetics, medical  and/or plant-derived products. Able to play an active role in his/her own personal professional development, as well as that of colleagues and pharmaceutical students.

 

 

 

 

13

Able to play a role in issues related to public health as a member of the health care team while being cognizant of and able to fulfill legal and professional requirements and maintain ethical standards. 

 

 

 

 

14

Is knowledgable of and equipped to manage the planning, development, compounding and quality control analysis of naturally occuring and synthetic medicines, while also being aware of the processes related to these products’ absorption, distribution, metabolism and excretion from the body.

 

 

 

 

 

 

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