GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
KINETIC PRINCIPLES AND STABILTY-PRACTICE/FTE-1041
Course Title: KINETIC PRINCIPLES AND STABILTY-PRACTICE
Credits 2 ECTS 7
Semester 1 Compulsory/Elective Elective
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Prof. Füsun Acartürk, Assoc.Prof. Dr. Tuba İnceçayır, Assoc.Prof. Dr. Sibel İlbasmış Tamer
 -- WEB SITE(S) OF LECTURER(S)
  http://websitem.gazi.edu.tr/site/acarturk, http://www.websitem.gazi.edu.tr/site/tincecayir, http://www.websitem.gazi.edu.tr/site/ilbasmis
 -- EMAIL(S) OF LECTURER(S)
  acarturk@gazi.edu.tr, tubaincecayir@gmail.com, ilbasmis@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Experimentally learn the active ingredients/drug degradation mechanism, degradation kinetics, half life and shelf life calculations of the active ingr
Gain the ability to follow the published guidelines of the health authorities(FDA,EMA,ICH,WHO) and the official reference boks
Learn the interpretation and statistical evaluation of the stability test results and how to practically apply them






 -- MODE OF DELIVERY
  The mode of delivery of this course is face to face
 -- PREREQUISITES AND CO-REQUISITES
  There is no prerequisite or co-requisite for this course.
 -- RECOMMENDED OPTIONAL PROGRAMME COMPONENTS
  There is no recommended optional programme component for this course
 --COURSE CONTENT
1. Week  Stability and the basic concepts
2. Week  Basic reactions (Zero, first and second reactions)
3. Week  Complex reactions-Reversible and paralel reaction calculations
4. Week  Complex reactions-Consecutive reaction calculations
5. Week  The calculations of the half life and shelf life
6. Week  Photostability tests
7. Week  Accelerated stability tests
8. Week  Stress tests
9. Week  Long term stability tests
10. Week  Isothermal stability tests
11. Week  Nonisothermal stability tests
12. Week  The stabilty tests design for the different type of drug products
13. Week  The stabilty test protocols
14. Week  The statistical evaluation of the stability tests
15. Week  
16. Week  
 -- RECOMMENDED OR REQUIRED READING
  Alfred Martin,Physical Pharmacy, Williams & Wilkins, Maryland, USA Remington: The Science and Practice of Pharmacy, Ed: AR Gennaro, 20th Ed., Lippin
 -- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
  Lecture, Question & Answer, Demonstration, Drill - Practise
 -- WORK PLACEMENT(S)
  Labrotory studies
 -- ASSESSMENT METHODS AND CRITERIA
 
Quantity
Percentage
 Mid-terms
0
0
 Assignment
1
10
 Exercises
0
0
 Projects
0
0
 Practice
1
50
 Quiz
0
0
 Contribution of In-term Studies to Overall Grade  
60
 Contribution of Final Examination to Overall Grade  
40
 -- WORKLOAD
 Efficiency  Total Week Count  Weekly Duration (in hour)  Total Workload in Semester
 Theoretical Study Hours of Course Per Week
0
 Practising Hours of Course Per Week
14
3
42
 Reading
10
3
30
 Searching in Internet and Library
12
2
24
 Designing and Applying Materials
10
2
20
 Preparing Reports
10
3
30
 Preparing Presentation
3
4
12
 Presentation
2
3
6
 Mid-Term and Studying for Mid-Term
1
5
5
 Final and Studying for Final
1
6
6
 Other
0
 TOTAL WORKLOAD: 
175
 TOTAL WORKLOAD / 25: 
7
 ECTS: 
7
 -- COURSE'S CONTRIBUTION TO PROGRAM
NO
PROGRAM LEARNING OUTCOMES
1
2
3
4
5
1Posesses extensive knowledge accumulation on the field of Pharmaceutical Technology, learns pre-formulations of all pharmaceutical dosage forms, formulation designs and in vitro/in vivo evaluations of formulations.X
2Gains the capability of following up novalities in technology, and posesses the capability of literature search, evaluation and interpretation on the fields of Pharmacy.X
3Gains the capability of patent search and evaluation and patenting regarding the formulations of active drug ingredient, dosage forms and preparation technologies.X
4Learns sufficient knowledge on the the field of laboratory, pilot batch and industrial scale productions, quality controls, quality assurance system, good manufacture practice (GMP) and stability assurance of all dosage forms.X
5Learns the knowledge satisfying the capability level for designing original and generic drugs, evaluating process validation and quality assurance.X
6Learns the interpretation, statistical evaluation and practical application of the research results.X
7Posesses the knowledge on new drug delivery systems and posesses the knowledge and capacity on targetting these systems at a level of an expert.X
8Learns designing, formulations, preparation techniques, physical and chemical stabilities of biotechnological products.X
9Gains the capability of finding solutions to the problems encountered during research. He/she gains the capability of analytical thinking. He/she gains the capability of publishing the experimental results in the national/international journals.X
10Gains the capability of following and interpretion of important wold health organizations (FDA, EMA, ICH and WHO) and official reference books (pharmacopoeia etc.). As a result, he/she transfers his/her knowledge to the field of Pharmaceutical Technology, and develops new approaches.X