Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| PHARMACEUTICAL TECHNOLOGY IV | PHA4214878 | Spring Semester | 3+0 | 3 | 5 |
| Course Program | Salı 14:30-15:15 Salı 15:30-16:15 Salı 16:30-17:15 Cumartesi 14:30-15:15 Cumartesi 15:30-16:15 Cumartesi 16:30-17:15 |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | English |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Required |
| Course Coordinator | Prof.Dr. Fatma Julide AKBUĞA |
| Name of Lecturer(s) | Lect.Dr. Burcu ÜNER |
| Assistant(s) | |
| Aim | To inform the student about the preparation and quality controls of solid dosage forms, the stability tests and the licensing of drugs. |
| Course Content | This course contains; Powder preparation and micromeritic, adsorption isoterms,Capsules, granule and tablets,Tablets, tablet types,The coating of tablets,Micropellets,Extended release systems and modern therapeutic systems,Extended release systems and modern therapeutic systems,Extended release systems and modern therapeutic systems,Extended release systems and modern therapeutic systems,Veterinary and agricultural drugs,The drug licensing,The drug licensing,Stability,Radiopharmacy. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| At the and of this course, the students; | ||
| 1. Will be evaluated powder preparations and micromeritic. | 16, 9 | A |
| 1.1. Categorize powder preparations. | 16, 9 | A |
| 1.2. Debate the importance of particle size and distribution for powder preparations. | 16, 9 | A |
| 2. Will be defined granule, tablets, the coating of tablets and capsules. | 16, 9 | A |
| 2.1. Plan granulation process and the controls on granule. | 16, 9 | A |
| 2.2. Categorize the excipients of tablets. | 16, 9 | A |
| 2.3. Assess the preparation methods of tablets. | 16, 9 | A |
| 3. Will be evaluated micropellets, extended release systems and modern therapeutic systems. | 16, 9 | A |
| 3.1. Debate the preparation methods of micropellets. | 16, 9 | A |
| 3.2. Categorize extended release systems. | 16, 9 | A |
| 3.3. Design modern therapeutic systems. | 16, 9 | A |
| 4. Will be explained the stability of dosage forms. | 16, 9 | A |
| 4.1. Define active ingredient and drug stability. | 16, 9 | A |
| 4.2. Debate the current approaches about stability regulation, and the reaction kinetics of stability. | 16, 9 | A |
| 5. Will be defined veterinary and agricultural drugs. | 16, 9 | A |
| 5.1. Categorize veterinary drugs. | 16, 9 | A |
| 6. Will be evaluated the key issues related to the licensing of drugs. | 16, 9 | A |
| 6.1. Debate the issues about the licensing of drugs in Europaen Union and shortened license applications. | 16, 9 | A |
| 6.2. Interpret the drug licensing flowchart. | 16, 9 | A |
| Teaching Methods: | 16: Question - Answer Technique, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | Powder preparation and micromeritic, adsorption isoterms | 1,2,3 |
| 2 | Capsules, granule and tablets | 1,2,3 |
| 3 | Tablets, tablet types | 1,2,3 |
| 4 | The coating of tablets | 1,2,3 |
| 5 | Micropellets | 1,2,3 |
| 6 | Extended release systems and modern therapeutic systems | 1,2,3 |
| 7 | Extended release systems and modern therapeutic systems | 1,2,3 |
| 8 | Extended release systems and modern therapeutic systems | 1,2,3 |
| 9 | Extended release systems and modern therapeutic systems | 1,2,3 |
| 10 | Veterinary and agricultural drugs | 1,2,3 |
| 11 | The drug licensing | 1,2,3 |
| 12 | The drug licensing | 1,2,3 |
| 13 | Stability | 1,2,3 |
| 14 | Radiopharmacy | 1,2,3 |
| Resources |
| 1. Ders notu derste öğrencilere verilecektir. 2. Acartürk F, Ağabeyoğlu İ, Çelebi D, Değim T, Değim Z, Doğanay T, Taka S, Tırnaksız F. Modern Farmasötik Teknoloji. Türk Eczacılar Birliği Yayını, 2.baskı, Ankara, 2008. 3. Zırh Gürsoy A (ed.). Farmasötik Teknoloji –Temel Konular ve Dozaj Şekilleri- Kontrollü Salım Sistemleri Derneği Yayını. 2.baskı. İstanbul, 2012. |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PQ-1. Skilfully use information technology to access, follow, evaluate and apply current knowledge in the field of Pharmaceutical Sciences. | X | |||||
| 2 | PQ-2. Have advanced knowledge in APIs and DPs. | X | |||||
| 3 | PQ-3. Collaborate with the experts for collection, interpretation, application and declaration of data in Pharmaceutical Sciences field. | X | |||||
| 4 | PQ-4. Provide best patient counseling services and medication therapy management using his/her knowledge and pharmaceutical information systems to improve the quality of life and safety of patient. | X | |||||
| 5 | PQ-5. Capable of organizing and administering a drugstore as per responsibilities prescribed under the Pharmacy Law, using skills, knowledge and advanced technology systems. | X | |||||
| 6 | PQ-6. Skilfully use computer programs and advanced technology related to the Pharmaceutical Sciences. | X | |||||
| 7 | PQ-7. Provide solutions to the professional issues using scientific knowledge and data. | X | |||||
| 8 | PQ-8. Perform identification, quality control and standardization of the drug products. | X | |||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | X | |||||
| 10 | PQ-10. Capable of conducting independent studies with his/her advanced knowledge in pharmaceutical sciences, takes responsibilities in professional organizations and efficiently collaborates with the members of his/her own organization as well as other organizations. | X | |||||
| 11 | PQ-11. Clearly show signs of adoption of life-long learning and openness to further development. | X | |||||
| 12 | PQ-12. Critically evaluate their knowledge in pharmaceutical sciences. | X | |||||
| 13 | PQ-13. Closely follow and evaluate the national and international professional developments. | X | |||||
| 14 | PQ-14. Record and document all professional activities and applications. | X | |||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | X | |||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | X | |||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | X | |||||
| 18 | PQ-18. Actively involve in the preparation of APIs, every stage of the formulation and production of DPs. | X | |||||
| 19 | PQ-19. Knowledgable in the regulatory rules of new drug application, data protection and patent issues and understand their interrelationship. | X | |||||
| 20 | PQ-20. Have awareness of his/her duties, rights and responsibilities and act based on Pharmacy Law and high professional ethical standards. | X | |||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | X | |||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |
| ECTS / Workload Table | ||||||
| Activities | Number of | Duration(Hour) | Total Workload(Hour) | |||
| Course Hours | 14 | 3 | 42 | |||
| Guided Problem Solving | 0 | 0 | 0 | |||
| Resolution of Homework Problems and Submission as a Report | 2 | 5 | 10 | |||
| Term Project | 0 | 0 | 0 | |||
| Presentation of Project / Seminar | 0 | 0 | 0 | |||
| Quiz | 0 | 0 | 0 | |||
| Midterm Exam | 1 | 30 | 30 | |||
| General Exam | 1 | 60 | 60 | |||
| Performance Task, Maintenance Plan | 0 | 0 | 0 | |||
| Total Workload(Hour) | 142 | |||||
| Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(142/30) | 5 | |||||
| ECTS of the course: 30 hours of work is counted as 1 ECTS credit. | ||||||
Detail Informations of the Course
Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| PHARMACEUTICAL TECHNOLOGY IV | PHA4214878 | Spring Semester | 3+0 | 3 | 5 |
| Course Program | Salı 14:30-15:15 Salı 15:30-16:15 Salı 16:30-17:15 Cumartesi 14:30-15:15 Cumartesi 15:30-16:15 Cumartesi 16:30-17:15 |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | English |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Required |
| Course Coordinator | Prof.Dr. Fatma Julide AKBUĞA |
| Name of Lecturer(s) | Lect.Dr. Burcu ÜNER |
| Assistant(s) | |
| Aim | To inform the student about the preparation and quality controls of solid dosage forms, the stability tests and the licensing of drugs. |
| Course Content | This course contains; Powder preparation and micromeritic, adsorption isoterms,Capsules, granule and tablets,Tablets, tablet types,The coating of tablets,Micropellets,Extended release systems and modern therapeutic systems,Extended release systems and modern therapeutic systems,Extended release systems and modern therapeutic systems,Extended release systems and modern therapeutic systems,Veterinary and agricultural drugs,The drug licensing,The drug licensing,Stability,Radiopharmacy. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| At the and of this course, the students; | ||
| 1. Will be evaluated powder preparations and micromeritic. | 16, 9 | A |
| 1.1. Categorize powder preparations. | 16, 9 | A |
| 1.2. Debate the importance of particle size and distribution for powder preparations. | 16, 9 | A |
| 2. Will be defined granule, tablets, the coating of tablets and capsules. | 16, 9 | A |
| 2.1. Plan granulation process and the controls on granule. | 16, 9 | A |
| 2.2. Categorize the excipients of tablets. | 16, 9 | A |
| 2.3. Assess the preparation methods of tablets. | 16, 9 | A |
| 3. Will be evaluated micropellets, extended release systems and modern therapeutic systems. | 16, 9 | A |
| 3.1. Debate the preparation methods of micropellets. | 16, 9 | A |
| 3.2. Categorize extended release systems. | 16, 9 | A |
| 3.3. Design modern therapeutic systems. | 16, 9 | A |
| 4. Will be explained the stability of dosage forms. | 16, 9 | A |
| 4.1. Define active ingredient and drug stability. | 16, 9 | A |
| 4.2. Debate the current approaches about stability regulation, and the reaction kinetics of stability. | 16, 9 | A |
| 5. Will be defined veterinary and agricultural drugs. | 16, 9 | A |
| 5.1. Categorize veterinary drugs. | 16, 9 | A |
| 6. Will be evaluated the key issues related to the licensing of drugs. | 16, 9 | A |
| 6.1. Debate the issues about the licensing of drugs in Europaen Union and shortened license applications. | 16, 9 | A |
| 6.2. Interpret the drug licensing flowchart. | 16, 9 | A |
| Teaching Methods: | 16: Question - Answer Technique, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | Powder preparation and micromeritic, adsorption isoterms | 1,2,3 |
| 2 | Capsules, granule and tablets | 1,2,3 |
| 3 | Tablets, tablet types | 1,2,3 |
| 4 | The coating of tablets | 1,2,3 |
| 5 | Micropellets | 1,2,3 |
| 6 | Extended release systems and modern therapeutic systems | 1,2,3 |
| 7 | Extended release systems and modern therapeutic systems | 1,2,3 |
| 8 | Extended release systems and modern therapeutic systems | 1,2,3 |
| 9 | Extended release systems and modern therapeutic systems | 1,2,3 |
| 10 | Veterinary and agricultural drugs | 1,2,3 |
| 11 | The drug licensing | 1,2,3 |
| 12 | The drug licensing | 1,2,3 |
| 13 | Stability | 1,2,3 |
| 14 | Radiopharmacy | 1,2,3 |
| Resources |
| 1. Ders notu derste öğrencilere verilecektir. 2. Acartürk F, Ağabeyoğlu İ, Çelebi D, Değim T, Değim Z, Doğanay T, Taka S, Tırnaksız F. Modern Farmasötik Teknoloji. Türk Eczacılar Birliği Yayını, 2.baskı, Ankara, 2008. 3. Zırh Gürsoy A (ed.). Farmasötik Teknoloji –Temel Konular ve Dozaj Şekilleri- Kontrollü Salım Sistemleri Derneği Yayını. 2.baskı. İstanbul, 2012. |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PQ-1. Skilfully use information technology to access, follow, evaluate and apply current knowledge in the field of Pharmaceutical Sciences. | X | |||||
| 2 | PQ-2. Have advanced knowledge in APIs and DPs. | X | |||||
| 3 | PQ-3. Collaborate with the experts for collection, interpretation, application and declaration of data in Pharmaceutical Sciences field. | X | |||||
| 4 | PQ-4. Provide best patient counseling services and medication therapy management using his/her knowledge and pharmaceutical information systems to improve the quality of life and safety of patient. | X | |||||
| 5 | PQ-5. Capable of organizing and administering a drugstore as per responsibilities prescribed under the Pharmacy Law, using skills, knowledge and advanced technology systems. | X | |||||
| 6 | PQ-6. Skilfully use computer programs and advanced technology related to the Pharmaceutical Sciences. | X | |||||
| 7 | PQ-7. Provide solutions to the professional issues using scientific knowledge and data. | X | |||||
| 8 | PQ-8. Perform identification, quality control and standardization of the drug products. | X | |||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | X | |||||
| 10 | PQ-10. Capable of conducting independent studies with his/her advanced knowledge in pharmaceutical sciences, takes responsibilities in professional organizations and efficiently collaborates with the members of his/her own organization as well as other organizations. | X | |||||
| 11 | PQ-11. Clearly show signs of adoption of life-long learning and openness to further development. | X | |||||
| 12 | PQ-12. Critically evaluate their knowledge in pharmaceutical sciences. | X | |||||
| 13 | PQ-13. Closely follow and evaluate the national and international professional developments. | X | |||||
| 14 | PQ-14. Record and document all professional activities and applications. | X | |||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | X | |||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | X | |||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | X | |||||
| 18 | PQ-18. Actively involve in the preparation of APIs, every stage of the formulation and production of DPs. | X | |||||
| 19 | PQ-19. Knowledgable in the regulatory rules of new drug application, data protection and patent issues and understand their interrelationship. | X | |||||
| 20 | PQ-20. Have awareness of his/her duties, rights and responsibilities and act based on Pharmacy Law and high professional ethical standards. | X | |||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | X | |||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |