GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
PRE-FORMULATION – PRACTICE/FTE-1031
Course Title: PRE-FORMULATION – PRACTICE
Credits 2 ECTS 7
Semester 1 Compulsory/Elective Elective
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
   Turkish
 -- NAME OF LECTURER(S)
  Prof.Dr. Sevgi Takka, Assoc. Prof. Fatmanur Tuğcu Demiröz, Prof.Dr. Füsun Acartürk
 -- WEB SITE(S) OF LECTURER(S)
  http://websitem.gazi.edu.tr/site/takka,http://websitem.gazi.edu.tr/site/fatmanur, http://websitem.gazi.edu.tr/site/acarturk
 -- EMAIL(S) OF LECTURER(S)
  takka@gazi.edu.tr, fatmanur@gazi.edu.tr, acarturk@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Defines the necessary concepts and skills to develope the formulation and describes the physical factors of drug substance and excipients that affects
Characterizes the phyisochemical properties of active substance (solubility, particle size, partion coefficient, ionization constant)
Investigates the polymorphic transformation, stability and the interaction of drug substance and excipients
 -- 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  The evaluation the physical characteristics of the active substances and excipients
2. Week  The evaluation of physical chracteristics with thermal analysis methods
3. Week  The evaluation of physical characteristics with spectrofotometer methods
4. Week  The evaluation of characteristics of the powders
5. Week  Analysis of crystal characteristics
6. Week  Bulk and tap density and the evaluation methods
7. Week  The particle size of the powders and the analysis methods
8. Week  The flowing properties of the powders
9. Week  Solubility and the intrinsic solubility
10. Week  The methods of the increasing solubility
11. Week  Intrinsic dissolution study
12. Week  The dissolution methods-Paddle and basket
13. Week  The dissolution methods-Flow through cell
14. Week  The interactions of the drug-excipient
15. Week  
16. Week  
 -- RECOMMENDED OR REQUIRED READING
  - Pharmaceutical Preformulation and Formulation, Ed: M Gibson, Interpharm/CRC, Boca Raton, 2004. - Remington: The Science and Practice of Pharmacy, E
 -- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
  Lecture, Question & Answer, Demonstration, Drill - Practise
 -- WORK PLACEMENT(S)
  NA
 -- ASSESSMENT METHODS AND CRITERIA
 
Quantity
Percentage
 Mid-terms
0
0
 Assignment
1
30
 Exercises
0
0
 Projects
1
30
 Practice
0
0
 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
4
56
 Reading
3
4
12
 Searching in Internet and Library
5
3
15
 Designing and Applying Materials
12
3
36
 Preparing Reports
4
4
16
 Preparing Presentation
3
4
12
 Presentation
3
4
12
 Mid-Term and Studying for Mid-Term
1
7
7
 Final and Studying for Final
1
9
9
 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