Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| PHARMACEUTICAL TECHNOLOGY III | - | Fall Semester | 3+0 | 3 | 5 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Required |
| Course Coordinator | Prof.Dr. Fatma Julide AKBUĞA |
| Name of Lecturer(s) | Assist.Prof. Muhammet Davut ARPA, Prof.Dr. Fatma Julide AKBUĞA |
| Assistant(s) | |
| Aim | To explain the preparation methods of sterile dosage forms, the design of the sterile areas, the pharmaceutical packaging materials, GMP, and quality assurance topics. |
| Course Content | This course contains; Parenteral preparations I,Parenteral preparations II,Parenteral preparations III,Ocular drugs,Sterilization and contamination,Nasal preparations ,Sterile area and it’s design I,Sterile area and it’s design II,GMP, quality assurance, validation I,GMP, quality assurance, validation II,Medical devices and products,Drug incompatibility,Pharmaceutical packaging materials and Surgical materials,Biotechnological Drugs. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| 1. will be telled the basic knowledge and calculations about the pharmaceutical formulations. | 16, 9 | A |
| 1.1. define the basic concepts of the isotonic solutions. | 16, 9 | A |
| 1.2. interpret isotonicity and isohidricity concept. | 16, 9 | A |
| 1.3. categorize the methods of isotonic solution preparation. | 16, 9 | A |
| 1.4. design parenteral dosage forms. | 16, 9 | A |
| 2. will be interpreted the knowledge about ocular, otic and nasal preparations. | 16, 9 | A |
| 2.1. design ocular, otic and nasal preparations. | 16, 9 | A |
| 2.2. categorize the excipient used in ocular, otic and nasal preparations. | 16, 9 | A |
| 3. will be defined the design of sterile areas and sterilization. | 16, 9 | A |
| 3.1. categorize the sterilization methods. | 16, 9 | A |
| 3.2. evaluate the conditions that must be considered in the design of the sterile areas. | 16, 9 | A |
| 4. will be assessed pharmaceutical packaging materials and drug incompatibility. | 16, 9 | A |
| 4.1. categorize pharmaceutical packaging materials. | 16, 9 | A |
| 4.2. define the physical and chemical raections that cause drug incompatibility. | 16, 9 | A |
| 4.3. plan the solution methods of drug incompatibility. | 16, 9 | A |
| 5. will be evaluated current approaches about GMP and quality assurance issues. | 16, 9 | A |
| 5.1. define GMP ve GLP concepts. | 16, 9 | A |
| 5.2. interpret the compliance of GMP for the pharmaceutical industry. | 16, 9 | A |
| 6. will be assessed medical devices, medical products and surgical materials. | 16, 9 | A |
| 6.1. interpret the regulations about medical devices and products. | 16, 9 | A |
| 6.2. recognize the medical materials in community pharmacies and the medical products in hospitals. | 16, 9 | A |
| 6.3. explain the definitions of health equipments and interventional surgical products (stents etc.). | 16, 9 | A |
| 6.4. assess the basic knowledge and quality controls of surgical materials. | 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 | Parenteral preparations I | 1,2,3 |
| 2 | Parenteral preparations II | 1,2,3 |
| 3 | Parenteral preparations III | 1,2,3 |
| 4 | Ocular drugs | 1,2,3 |
| 5 | Sterilization and contamination | 1,2,3 |
| 6 | Nasal preparations | 1,2,3 |
| 7 | Sterile area and it’s design I | 1,2,3 |
| 8 | Sterile area and it’s design II | 1,2,3 |
| 9 | GMP, quality assurance, validation I | 1,2,3 |
| 10 | GMP, quality assurance, validation II | 1,2,3 |
| 11 | Medical devices and products | 1,2,3 |
| 12 | Drug incompatibility | 1,2,3 |
| 13 | Pharmaceutical packaging materials and Surgical materials | 1,2,3 |
| 14 | Biotechnological Drugs | 1,2,3 |
| Resources |
| 1-Lecture notes, powerpoint presentations, relevant web pages will be given to students. |
| 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. Zırh Gürsoy A (ed.). 3-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. | ||||||
| 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 III | - | Fall Semester | 3+0 | 3 | 5 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Required |
| Course Coordinator | Prof.Dr. Fatma Julide AKBUĞA |
| Name of Lecturer(s) | Assist.Prof. Muhammet Davut ARPA, Prof.Dr. Fatma Julide AKBUĞA |
| Assistant(s) | |
| Aim | To explain the preparation methods of sterile dosage forms, the design of the sterile areas, the pharmaceutical packaging materials, GMP, and quality assurance topics. |
| Course Content | This course contains; Parenteral preparations I,Parenteral preparations II,Parenteral preparations III,Ocular drugs,Sterilization and contamination,Nasal preparations ,Sterile area and it’s design I,Sterile area and it’s design II,GMP, quality assurance, validation I,GMP, quality assurance, validation II,Medical devices and products,Drug incompatibility,Pharmaceutical packaging materials and Surgical materials,Biotechnological Drugs. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| 1. will be telled the basic knowledge and calculations about the pharmaceutical formulations. | 16, 9 | A |
| 1.1. define the basic concepts of the isotonic solutions. | 16, 9 | A |
| 1.2. interpret isotonicity and isohidricity concept. | 16, 9 | A |
| 1.3. categorize the methods of isotonic solution preparation. | 16, 9 | A |
| 1.4. design parenteral dosage forms. | 16, 9 | A |
| 2. will be interpreted the knowledge about ocular, otic and nasal preparations. | 16, 9 | A |
| 2.1. design ocular, otic and nasal preparations. | 16, 9 | A |
| 2.2. categorize the excipient used in ocular, otic and nasal preparations. | 16, 9 | A |
| 3. will be defined the design of sterile areas and sterilization. | 16, 9 | A |
| 3.1. categorize the sterilization methods. | 16, 9 | A |
| 3.2. evaluate the conditions that must be considered in the design of the sterile areas. | 16, 9 | A |
| 4. will be assessed pharmaceutical packaging materials and drug incompatibility. | 16, 9 | A |
| 4.1. categorize pharmaceutical packaging materials. | 16, 9 | A |
| 4.2. define the physical and chemical raections that cause drug incompatibility. | 16, 9 | A |
| 4.3. plan the solution methods of drug incompatibility. | 16, 9 | A |
| 5. will be evaluated current approaches about GMP and quality assurance issues. | 16, 9 | A |
| 5.1. define GMP ve GLP concepts. | 16, 9 | A |
| 5.2. interpret the compliance of GMP for the pharmaceutical industry. | 16, 9 | A |
| 6. will be assessed medical devices, medical products and surgical materials. | 16, 9 | A |
| 6.1. interpret the regulations about medical devices and products. | 16, 9 | A |
| 6.2. recognize the medical materials in community pharmacies and the medical products in hospitals. | 16, 9 | A |
| 6.3. explain the definitions of health equipments and interventional surgical products (stents etc.). | 16, 9 | A |
| 6.4. assess the basic knowledge and quality controls of surgical materials. | 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 | Parenteral preparations I | 1,2,3 |
| 2 | Parenteral preparations II | 1,2,3 |
| 3 | Parenteral preparations III | 1,2,3 |
| 4 | Ocular drugs | 1,2,3 |
| 5 | Sterilization and contamination | 1,2,3 |
| 6 | Nasal preparations | 1,2,3 |
| 7 | Sterile area and it’s design I | 1,2,3 |
| 8 | Sterile area and it’s design II | 1,2,3 |
| 9 | GMP, quality assurance, validation I | 1,2,3 |
| 10 | GMP, quality assurance, validation II | 1,2,3 |
| 11 | Medical devices and products | 1,2,3 |
| 12 | Drug incompatibility | 1,2,3 |
| 13 | Pharmaceutical packaging materials and Surgical materials | 1,2,3 |
| 14 | Biotechnological Drugs | 1,2,3 |
| Resources |
| 1-Lecture notes, powerpoint presentations, relevant web pages will be given to students. |
| 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. Zırh Gürsoy A (ed.). 3-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. | ||||||
| 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 | |