GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
KINETIC PRINCIPLES AND STABILITY/FTE-1130
Course Title: KINETIC PRINCIPLES AND STABILITY
Credits 3 ECTS 8
Semester 1 Compulsory/Elective Compulsory
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Prof. Füsun Acartürk, Assoc.Prof. Tuba İnceçayır, Assoc.Prof. Sibel İlbasmış Tamer
 -- WEB SITE(S) OF LECTURER(S)
  http://www.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
Learning and discussion of basic concepts of stability
Learning of degradation mechanism and kinetics, shelf life and half-life calculations of active substances
Gaining the ability to follow the guidelines and official reference books published by the health authorities (FDA, EMA, ICH, WHO) in relation to stab
Interpretation of the stability test results, statistical evaluation and practical applications





 -- 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 basic concepts
2. Week  Reaction kinetics
3. Week  Simple reactionkinetics (Zero, first end second order reactions)
4. Week  Simple reactionkinetics (Zero, first end second order reactions)
5. Week  Complex reactions
6. Week  Calculations of half-life and shelf life
7. Week  The factors affected reaction kinetics
8. Week  Degradation mechanism
9. Week  Stability guidelines
10. Week  Isothermal stability tests
11. Week  Non-isothermal stability tests
12. Week  Statistical assessment of stability test results
13. Week  The influence of packing on the stability of drug dosage forms
14. Week  The stability tests for different dosage forms
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 Handbook of Stability Testing in Pharmaceutical Development, Kim Huynh-Ba, Springer, 2009.
 -- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
  Lecture, Question & Answer, Demonstration,
 -- WORK PLACEMENT(S)
  -
 -- ASSESSMENT METHODS AND CRITERIA
 
Quantity
Percentage
 Mid-terms
1
10
 Assignment
0
0
 Exercises
0
0
 Projects
1
30
 Practice
0
0
 Quiz
0
0
 Contribution of In-term Studies to Overall Grade  
40
 Contribution of Final Examination to Overall Grade  
60
 -- WORKLOAD
 Efficiency  Total Week Count  Weekly Duration (in hour)  Total Workload in Semester
 Theoretical Study Hours of Course Per Week
14
3
42
 Practising Hours of Course Per Week
0
0
0
 Reading
10
3
30
 Searching in Internet and Library
10
3
30
 Designing and Applying Materials
10
2
20
 Preparing Reports
10
4
40
 Preparing Presentation
3
7
21
 Presentation
1
3
3
 Mid-Term and Studying for Mid-Term
1
5
5
 Final and Studying for Final
1
9
9
 Other
0
0
0
 TOTAL WORKLOAD: 
200
 TOTAL WORKLOAD / 25: 
8
 ECTS: 
8
 -- 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