Course Information


Course Information
Course Title Code Semester L+U Hour Credits ECTS
PHARMACEUTICAL TECHNOLOGY IV PHM4008 8. Semester 4 + 0 4.0 5.0

Prerequisites None

Language of Instruction English
Course Level Bachelor's Degree
Course Type Compulsory
Mode of delivery
Course Coordinator
Instructors Burcu DEVRİM GÖKBERK
Assistants Müge KILIÇARSLAN
ASLIHAN HİLAL ALGAN
Umut Can ÖZ
Goals It gives information about parenteral preparation technology.
Course Content It provides pharmaceutical information about parenteral solutions (osmosis, diffusion and dialysis, isotony and isohydrin, parenteral manufacturing technology, filtration and ultrafiltration, sterilization), eye, nose and ear drops, drug stability and reaction kinetics, incompatibility, biopharmaceutical and pharmacokinetics, radiopharmaceuticals.
Learning Outcomes 1) Know the manufacturing technologies and quality controls of parenteral solutions
2) Know the production technologies and quality controls of eye-ear-nose preparations
3) Learn drug stability and reaction kinetics
4) Learn information about medication incompatibility
5) Know biopharmaceutical and pharmacokinetic applications and evaluations
6) Know the production technology and evaluations of radiopharmaceuticals
7) Learn applications and evaluations of pharmaceutical biotechnology
8) Know the evaluations about good manufacturing practices

Weekly Topics (Content)
Week Topics Teaching and Learning Methods and Techniques Study Materials
1. Week Parenteral Preparation Technology Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
2. Week Parenteral Preparation Technology Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
3. Week Parenteral Preparation Technology Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
4. Week Quality Control and Packaging in Parenteral Preparations Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
5. Week Eye, Ear, Nose Preparations Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
6. Week Stability Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
7. Week Stability Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
8. Week Stability Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
9. Week Mid-term Exam Question Answer

 Homework
10. Week Pharmaceutical Biotechnology Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
11. Week Biopharmaceutics Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
12. Week Pharmacokinetics Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
13. Week GMP Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
14. Week Dissensions Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
15. Week Radiopharmacy Lecture
Brainstorming
Problem Based Learning 		Presentation (Including Preparation Time)
16. Week Final Exam Question Answer

 Homework

Sources Used in This Course
Recommended Sources
Acartürk, F. ve ark., Modern Farmasötik Teknoloji, TEB Eczacılık Akademisi yayınları, 2009
Anurag Singh Rathore, Gail Sofer., Process Validation in Manufacturing of Biopharmaceuticals, Gudilines, Current Practices and Industrial Case Studies, 2005.
Aulton, M.E., Pharmaceutics: The Science of Dosage Form Design, Elsevier, 2004
Avis, K.E., Lachman, L., Liberman, H.A., Pharmaceutical Dosage Forms: Parenteral Medications Vol1-2, Marcel Dekker, Inc., New York 1984.
Enver İzgü, İlaç San. Milli ve Milletlerarası Kanunlar Anlaşmalar, Yönetmelikler Yönünden İyi İmalat ve Kontrol Uygulama Kuralları, A. Ü. Basımevi, 1988.
ICH, FDA, WHO ve PIC yönetmelik ve rehberleri
Konuyla ilgili makale taramaları
Martin, A., Physical Pharmacy, Lıppincort Williams&Wilkins, 1993
Martin, D. Hyness, Pharmaceutical Pre-Approval Inspections, Guide to regulatory Success, 2 nd. Ed, 2008.
The European Agency for the Evaluation of Medicinal Products, CPMC/ICH/273/99, (ICH Q1a(R2)), 2003

Relations with Education Attainment Program Course Competencies
Program RequirementsContribution LevelDK1DK2DK3DK4DK5DK6DK7DK8
PY1500000000
PY2544455545
PY3544444555
PY4500000000
PY5555554445

*DK = Course's Contrubution.
0 1 2 3 4 5
Level of contribution None Very Low Low Fair High Very High
.

ECTS credits and course workload
Event Quantity Duration (Hour) Total Workload (Hour)
Course Duration (Total weeks*Hours per week) 14 4
Work Hour outside Classroom (Preparation, strengthening) 14 4
Midterm Exam 1 2
Time to prepare for Midterm Exam 1 10
Final Exam 1 2
Time to prepare for Final Exam 1 30
Total Workload
Total Workload / 30 (s)
ECTS Credit of the Course
Quick Access Hızlı Erişim Genişlet
Course Information
  • Course Information
  • Weekly Topics (Content)
  • Sources Used in This Course
  • Relations with Education Attainment Program Course Competencies
  • ECTS credits and course workload