GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
PRE-FORMULATION/FTE-1120
Course Title: PRE-FORMULATION
Credits 3 ECTS 8
Semester 1 Compulsory/Elective Compulsory
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Prof.Dr.Sevgi Takka, Prof.Dr. Füsun Acartürk, Fatmanur Tuğcu Demiröz
 -- WEB SITE(S) OF LECTURER(S)
  http://websitem.gazi.edu.tr/site/takka, http://websitem.gazi.edu.tr/site/acarturk, http://websitem.gazi.edu.tr/site/fatmanur
 -- EMAIL(S) OF LECTURER(S)
  takka@gazi.edu.tr, acarturk@gazi.edu.tr, fatmanur@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Defines the necessary concepts and skills to develope the pharmaceutical product
Describes the physicochemical factors, solubility, dissolution, particle size and distribution of drug substance
To have information on crystallinity and polymorphism, partion coefficient of substance, ionization constant and powder properties. Investigates s,
 -- 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  Development of dosage form and the importance of preformulation
2. Week  The evaluation the physicochemical characteristics of the active substances and excipients (DSC, TGA and x-ray diffraction)
3. Week  The evaluation of characteristics of the powders
4. Week  The evaluation of crystal chracteristics and polymorphism
5. Week  Analysis method of crystal chracteristics
6. Week  Bulk and tap density and the evaluation methods
7. Week  The particle size of the powders and analysis methods
8. Week  The flowing properties of the powders
9. Week  Solubility and the intrinsic solubility
10. Week  The methods of increasing solubility
11. Week  Intrinsic dissolution study
12. Week  The dissolution methods
13. Week  The importance of stability studies in preformulation
14. Week  The interaction 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, Ed: AR Gennaro, 20th Ed., Lippincott Williams & Wilkins, 2002. Remington: The Science and Practice of Pharmacy, Ed: AR Gennaro, 20th Ed., Lippincott Williams & Wilkins, 2002.
 -- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
  Lecture, Question & Answer, Demonstration
 -- WORK PLACEMENT(S)
  -
 -- ASSESSMENT METHODS AND CRITERIA
 
Quantity
Percentage
 Mid-terms
0
0
 Assignment
1
10
 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
 Reading
9
5
45
 Searching in Internet and Library
10
6
60
 Designing and Applying Materials
0
 Preparing Reports
3
6
18
 Preparing Presentation
3
5
15
 Presentation
1
3
3
 Mid-Term and Studying for Mid-Term
1
7
7
 Final and Studying for Final
1
10
10
 Other
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