| Course Type | Compulsory Course |
|---|
| Course Level | Master's Degree Without Thesis |
|---|
| Year of Study | 1 |
|---|
| Semester | Second Term (Spring) |
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| ECTS | 7 |
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| Name of Lecturer(s) |
|
| Learning Outcomes |
At the end of this course, the students;
- Learn the production technologies and process validations of different dosage forms.
- Knows the basic principles and production technologies of modified release dosage forms.
- Know the production conditions and production rules of sterile products.
- Know the application and interpretation of the guidelines published by health authorities.
- Use the acquired knowledge and skills in pharmaceutical industry and other institutions.
|
| Mode of Delivery | Face to face |
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| Prerequisites | No |
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| Recommended Optional Programme Components | None |
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| Course Description | This course covers the production technologies of different dosage forms, process validations, quality controls, production conditions of sterile products, and legal regulations related to drug production. |
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| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
Unit operations in the production of dosage forms |
|
2nd Week |
Production technologies and process validations of liquid dosage forms and practical |
|
3rd Week |
Production technologies and process validations of semi-solid dosage forms and practical |
|
4th Week |
Production technologies and process validations of solid dosage forms (Tablets) and practical |
|
5th Week |
Production technologies and process validations of solid dosage forms (Hard gelatin / cellulose capsules) and practical |
|
6th Week |
Production technologies and process validations of soft gelatin capsules and practical |
|
7th Week |
MID TERM EXAMINATION |
|
8th Week |
Production technologies and process validations of modified release dosage forms and practical |
|
9th Week |
Coating Technology (powder, granule) and practical |
|
10th Week |
Coating Technology, pellet technology and practical |
|
11th Week |
Production methods and validation process of water, filtration, sterilization process validations and practical |
|
12th Week |
Production technologies of sterile product formulations and practical |
|
13th Week |
Production in aseptic environment |
|
14th Week |
Legal regulations (guidlines) related to production processes |
|
| Recommended or Required Reading | 1. Lecturer notes
2. Modern Farmasötik Teknoloji, TEB Eczacılık Akademisi Yayını (Acartürk,F., Ağabeyoğlu,İ., Çelebi,N., Değim, T., Değim, Z.,Doğanay,T.,Takka,S., Tırnaksız,F.,)
3. Modern Pharmaceutics, Ed: Banker GS, Marcel Dakker Inc. New York, 2008.
4. Kontrollü salım sistemleri, Ed. Ayla GÜRSOY, Elam Bilgisayar Basım ve Ambalaj San. Tic. Ltd. Şti., İstanbul , 2002. |
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| Planned Learning Activities and Teaching Methods |
- Lecture
- Discussion
- Questions/Answers
|
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| Assessment Methods and Criteria |
|
Quantity |
Percentage (%) |
| Mid-term |
1 |
10 |
| Assignment |
2 |
15 |
| Practice |
14 |
20 |
| Other |
1 |
5 |
| Total(%) |
|
50 |
| Contribution of In-term Studies to Overall Grade(%) |
|
50 |
| Contribution of Final Examination to Overall Grade(%) |
|
50 |
| Total(%) |
|
100 |
|
| ECTS Allocated Based on Student Workload |
| Activities |
Quantity |
Duration (Hour) |
Total Workload (Hour) |
| Midterm exam |
1 |
2 |
2 |
| Preparation for Quiz |
0 |
0 |
0 |
| Individual or group work |
14 |
4 |
56 |
| Preparation for Final exam |
1 |
18 |
18 |
| Course hours |
14 |
3 |
42 |
| Preparation for Midterm exam |
1 |
10 |
10 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
3 |
3 |
| Homework |
2 |
16 |
32 |
| Presentation (including preperation) |
1 |
12 |
12 |
| Literature review |
14 |
3 |
42 |
| Performance Practice |
14 |
1 |
14 |
| Total Work Load | 231 |
| Total Work Load / 30 (h) | 7.7 |
| ECTS Credit of the Course | 7 |
|
| Language of Instruction | Turkish |
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| Work Placement(s) | No |
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