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| ECZ4034 | Pharmaceutical Technology - IV | 3+0+0 | ECTS:3 | | Year / Semester | Spring Semester | | Level of Course | Second Cycle | | Status | Compulsory | | Department | DEPARTMENT of PHARMACEUTICS | | Prerequisites and co-requisites | None | | Mode of Delivery | | | Contact Hours | 14 weeks - 3 hours of lectures per week | | Lecturer | Dr. Öğr. Üyesi Hatice DEMİRTAŞ | | Co-Lecturer | DOCTOR LECTURER Özlem ÇOBAN, | | Language of instruction | Turkish | | Professional practise ( internship ) | None | | | | The aim of the course: | | To make calculations about parenteral preparations, to learn the parameters to be careful in production
To learn sterilization methods, which method should be preferred for which product, advantages and disadvantages of methods
Stability reaction kinetics, shelf life calculation
Types of incompatibility, precautions to be taken
To have information about GMP, GCP, GLP, GRP guidelines
To learn concepts releated to bioequivalence, bioequivalence, pharmaceutical equivalent, therapeutic equivalent
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| Learning Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | LO - 1 : | Can makes calculations related to parenteral preparations, knows the parameters to be taken care of in production and necessary properties of the place of production | 5 - 7 - 9 | 1,2,4,5,6, | | LO - 2 : | Knows sterilization methods, knows which method to choose for which product and the advantages and disadvantages of the methods | 5 - 7 - 9 | 1,2,4,5,6, | | LO - 3 : | Knows the stability reaction kinetics and calculates the shelf life.
Can designs stability work according to product characteristics | 5 - 7 - 9 | 1,2,4,5,6, | | LO - 4 : | Knows the types of incompatibilities and precautions to be taken, practically prepares incompatible prescriptions | 5 - 7 - 9 | 1,2,4,5,6, | | LO - 5 : | Has information about GMP, GCP, GLP, and GRP guidlines, knows what guidelines to follow in the process until a product is released to the market | 5 - 7 - 9 | 1,2,4,5,6, | | LO - 6 : | Have knowledge about bioavailability, bioequivalence, pharmaceutical equivalent, therapeutic equivalent concepts | 5 - 7 - 9 | 1,2,4,5,6, | | CTPO : Contribution to programme outcomes, TOA :Type of assessment (1: written exam, 2: Oral exam, 3: Homework assignment, 4: Laboratory exercise/exam, 5: Seminar / presentation, 6: Term paper), LO : Learning Outcome | | |
| Definiton of parenteral products, concepts related to parenteral preparations, production technology of parenteral preparations, sterilization, packaging, quality control and validation studies
Eye, nose and ear preparations
Biotechnological products
Biopharmaceutics-Pharmacokinetics
Stability
Incompatibility
GMP,GCP and related guidlines |
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| Course Syllabus | | Week | Subject | Related Notes / Files | | Week 1 | Parenteral preparations, definitions, properties, related calculations
| | | Week 2 | Production technology of parenteral preparations
| | | Week 3 | Quality control studies and validation in parenteral preparations
| | | Week 4 | Sterilization of parenteral preparations, Sterilization methods
| | | Week 5 | Packaging of parenteral preparations, properties of packaging materials
| | | Week 6 | Eye, ear and nose products
| | | Week 7 | Radiopharmaceuticals, their properties and preparations methods
| | | Week 8 | Biotechnology, biotechnological products, tehir stability
| | | Week 9 | Midterm | | | Week 10 | Types of incompatibility, precautions to be taken
| | | Week 11 | Stability and Reaction kinetics
| | | Week 12 | Stability and Reaction kinetics
| | | Week 13 | Theoretical: Stability and Reaction kinetics
| | | Week 14 | Biopharmaceutics-Pharmacokinetics, Bioavailability-Bioequivalence
| | | Week 15 | GMP and Quality management; Regulatory Approval and Patents in Pharmaceuticals
| | | Week 16 | Final examination | | | |
| 1 | TEB-Modern Farmasötik Teknoloji | | | 2 | Farmasötik Teknoloji- Temel Konular ve Dozaj Şekilleri. Kontrollü Salım Sistemleri Derneği, 2004. | | | |
| 1 | Türkiye Tıbbi Cihaz ve İlaç Kurumu, güncel stabilite Kılavuzları. | | | 2 | Good Manufacturing Practices for Pharmaceuticals, Sidney H. Willing, Marcel Dekker, 2001. | | | |
| Method of Assessment | | Type of assessment | Week No | Date | Duration (hours) | Weight (%) | | Mid-term exam | 9 | 16.04.2022 | 2 | 38 | | In-term studies (second mid-term exam) | 1
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15 | | 3 | 6 | | Quiz | 1
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15 | | 0,15 | 6 | | Laboratory exam | 16 | | 1 | 15 | | Oral exam | 1
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15 | | 0,08 | | | End-of-term exam | 14 | 06.06.2022 | 3 | 35 | | |
| Student Work Load and its Distribution | | Type of work | Duration (hours pw) | No of weeks / Number of activity | Hours in total per term | | Yüz yüze eğitim | 3 | 14 | 42 | | Laboratuar çalışması | 3 | 14 | 42 | | Arasınav için hazırlık | 2 | 7 | 14 | | Arasınav | 3 | 1 | 3 | | Kısa sınav | .15 | 13 | 1.95 | | Dönem sonu sınavı için hazırlık | 2 | 7 | 14 | | Dönem sonu sınavı | 3 | 1 | 3 | | Total work load | | | 119.95 |
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