ERU603 - PHARMACEUTICAL DOSAGE FORMS and THEIR QUALITY CONT
| Course Name | Code | Semester | Theory (hours/week) |
Application (hours/week) |
Credit | ECTS |
|---|---|---|---|---|---|---|
| PHARMACEUTICAL DOSAGE FORMS and THEIR QUALITY CONT | ERU603 | 1st Semester | 4 | 0 | 4 | 7 |
| Prequisites | ||||||
| Course language | Turkish | |||||
| Course type | Must | |||||
| Mode of Delivery | Face-to-Face | |||||
| Learning and teaching strategies | Lecture Discussion Preparing and/or Presenting Reports | |||||
| Instructor (s) | Prof.Dr. Yılmaz Çapan, Prof. Dr. Süeda Hekimoğlu, Prof. Dr. Sevda Şenel, Prof. Dr. Sema Çalış, Prof.Dr. Betül Arıca-Yegin, Doç.Dr. Sibel Pehlivan | |||||
| Course objective | Description of pharmaceutical dosage forms, formulation, characteristics, manufacturing and quality controls | |||||
| Learning outcomes |
| |||||
| Course Content | Description of the pharmaceutical dosage forms, formulation, manufacturing and controls. | |||||
| References | Lecture notes, basic reference books on pharmaceutical technology, current articles | |||||
Course outline weekly
| Weeks | Topics |
|---|---|
| Week 1 | Oral Solutions |
| Week 2 | Suspensions Emulsions |
| Week 3 | Solid dosage forms I |
| Week 4 | Solid dosage forms II |
| Week 5 | Dermal dosage forms: ointments, creams, gels, TDD |
| Week 6 | Midterm Exam |
| Week 7 | Rectal and vaginal dosage forms: Suppositories, ovules, pessaries |
| Week 8 | Aerosols, sprays, inhalation preparations |
| Week 9 | Strerile preparations I |
| Week 10 | Strerile preparations II |
| Week 11 | Micro/nano particle drug delivery systems: micro/nano particles, liposomes, niosomes |
| Week 12 | Modified release dosage forms |
| Week 13 | Recovery |
| Week 14 | |
| Week 15 | |
| Week 16 | Final Exam |
Assesment methods
| Course activities | Number | Percentage |
|---|---|---|
| Attendance | 0 | 0 |
| Laboratory | 0 | 0 |
| Application | 0 | 0 |
| Field activities | 0 | 0 |
| Specific practical training | 0 | 0 |
| Assignments | 0 | 0 |
| Presentation | 0 | 0 |
| Project | 0 | 0 |
| Seminar | 0 | 0 |
| Midterms | 1 | 50 |
| Final exam | 1 | 50 |
| Total | 100 | |
| Percentage of semester activities contributing grade succes | 1 | 50 |
| Percentage of final exam contributing grade succes | 1 | 50 |
| Total | 100 | |
WORKLOAD AND ECTS CALCULATION
| Activities | Number | Duration (hour) | Total Work Load |
|---|---|---|---|
| Course Duration (x14) | 14 | 4 | 56 |
| Laboratory | 0 | 0 | 0 |
| Application | 0 | 0 | 0 |
| Specific practical training | 0 | 0 | 0 |
| Field activities | 0 | 0 | 0 |
| Study Hours Out of Class (Preliminary work, reinforcement, ect) | 14 | 4 | 56 |
| Presentation / Seminar Preparation | 1 | 18 | 18 |
| Project | 0 | 0 | 0 |
| Homework assignment | 0 | 0 | 0 |
| Midterms (Study duration) | 1 | 80 | 80 |
| Final Exam (Study duration) | 0 | 0 | 0 |
| Total Workload | 30 | 106 | 210 |
Matrix Of The Course Learning Outcomes Versus Program Outcomes
| D.9. Key Learning Outcomes | Contrubition level* | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
| 1. Has basic theoretical concepts and related approaches to provide quality in control systems used in analytical data and method validations | X | ||||
| 1. Has basic theoretical concepts and related approaches to provide quality in control systems used in analytical data and method validations | X | ||||
| 2. Has capability to decide conformity tests and to evaluate results by arranging different conditions, planning the activities for method validation and quality control | X | ||||
| 2. Has capability to decide conformity tests and to evaluate results by arranging different conditions, planning the activities for method validation and quality control | X | ||||
| 3. Has able to evaluate statistical data used for licensing medicinal products | X | ||||
| 3. Has able to evaluate statistical data used for licensing medicinal products | X | ||||
| 4. Has knowledge on the definition of drug, formulations, properties, production and quality controls | X | ||||
| 4. Has knowledge on the definition of drug, formulations, properties, production and quality controls | X | ||||
| 5. Has knowledge on pharmaceutical technology in evaluating and/or preparing application dossier of licensing medicines | X | ||||
| 5. Has knowledge on pharmaceutical technology in evaluating and/or preparing application dossier of licensing medicines | X | ||||
| 6. Has pharmacological and toxicological knowledge for licensing medicinal products | X | ||||
| 6. Has pharmacological and toxicological knowledge for licensing medicinal products | X | ||||
| 7. Has satisfied knowledge on safely usage of medicines. | X | ||||
| 7. Has satisfied knowledge on safely usage of medicines. | X | ||||
| 8. Has basic and technical knowledge about radiopharmaceutics; preparing, evaluating and resulting ability for applied license dossier of radiopharmaceuticals. | X | ||||
| 8. Has basic and technical knowledge about radiopharmaceutics; preparing, evaluating and resulting ability for applied license dossier of radiopharmaceuticals. | X | ||||
| 9. Capable to perform researches on different subjects; can follow published scientific studies; can plan and end a research; able to write a report with the data. | X | ||||
| 9. Capable to perform researches on different subjects; can follow published scientific studies; can plan and end a research; able to write a report with the data. | X | ||||
| 10. Has a general idea on pharmaceutical biotechnology. | X | ||||
| 10. Has a general idea on pharmaceutical biotechnology. | X | ||||
| 11. Has basic and important pharmacological and toxicological knowledge on biological products. | X | ||||
| 11. Has basic and important pharmacological and toxicological knowledge on biological products. | X | ||||
| 12. Has a general knowledge in registration of natural medicines, medicine out products, cosmetics, and food supplements. | X | ||||
| 12. Has a general knowledge in registration of natural medicines, medicine out products, cosmetics, and food supplements. | X | ||||
| 13. Capable to discuss and/or defend pharmacoeconomic data in medicine licensing. | X | ||||
| 13. Capable to discuss and/or defend pharmacoeconomic data in medicine licensing. | X | ||||
| 14. Has basic and technical knowledge about radiopharmacy and has foreknowledge required for prepartio of license dossier of radiopharmaceuticals about radiopharmacy. | X | ||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest