GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
DISSOLUTION RATE AND RELEASE KINETICS FROM DOSAGE FORMS/FTE-2200
Course Title: DISSOLUTION RATE AND RELEASE KINETICS FROM DOSAGE FORMS
Credits 3 ECTS 8
Semester 1 Compulsory/Elective Compulsory
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Assoc.Prof.Zeynep Şafak Teksin, Assoc.Prof.Tuba İnceçayır
 -- WEB SITE(S) OF LECTURER(S)
  http://www.websitem.gazi.edu.tr/site/zsteksin, http://www.websitem.gazi.edu.tr/site/tincecayir
 -- EMAIL(S) OF LECTURER(S)
  zsteksin@gazi.edu.tr, tincecayir@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Learning basic concepts and knowledges on dissolution and dissolution kinetics through discussion
Learning dissolution methods
Learning comparison of dissolution profiles
 -- 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  Dissolution, solubility and dissolution rate concepts and importance of dissolution in Pharmaceutical Technology
2. Week  Factors affecting dissolution and solubility
3. Week  Intrinsic solubility and dissolution
4. Week  Dissolution methods and compendial dissolution methods and apparatus
5. Week  Validation of dissolution apparatus and test optimization
6. Week  Methods to increase solubility, solubilization, problems encountered in dissolution experiments and solutions
7. Week  Suggested dissolution media for poorly soluble drugs, fasted and fed state simulated intestinal fluids
8. Week  Dissolution methods developed for variable dosage forms
9. Week  Wetting kinetics of powders and theories of dissolution (Hixon-Crowell and Kitozawa equations)
10. Week  Kinetics of dissolution (Dankwerts and Weibull dissolution models)
11. Week  Kinetics of dissolution (RRSBW, El Yazici, Peppas), assessment of release kinetics from variable dosage forms
12. Week  Assessment of dissolution results and comparison of dissolution profiles (difference factor (f1 test) and similarity factor (f2 test))
13. Week  Concept of biowaiver, Biopharmaceutics Classification System (BCS)
14. Week  In vitro-in vivo corelation (IVIVC)
15. Week  
16. Week  
 -- RECOMMENDED OR REQUIRED READING
  1- Encyclopedia of Pharmaceutical Technology, (Ed: Swarbrick, J., Boylan, J.C.), Vol.3., Marcel and Dekker, New York and Basel, 1992. 2-H.M.Abdou. Dissolution, Bioavalability & Bioequivalance, Marcel and Dekker
 -- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
  Lecture, Question & Answer, Demonstration, Drill - Practise
 -- WORK PLACEMENT(S)
  -
 -- ASSESSMENT METHODS AND CRITERIA
 
Quantity
Percentage
 Mid-terms
1
30
 Assignment
1
10
 Exercises
0
0
 Projects
1
10
 Practice
0
0
 Quiz
0
0
 Contribution of In-term Studies to Overall Grade  
50
 Contribution of Final Examination to Overall Grade  
50
 -- 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
14
2
28
 Searching in Internet and Library
9
3
27
 Designing and Applying Materials
0
0
0
 Preparing Reports
4
8
32
 Preparing Presentation
5
7
35
 Presentation
2
6
12
 Mid-Term and Studying for Mid-Term
5
2
10
 Final and Studying for Final
7
2
14
 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