Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| PHARMACEUTICAL TECHNOLOGY LAB.III | PHA4114869 | Fall Semester | 0+3 | 1,5 | 3 |
| Course Program | ( A ) Salı 13:30-14:15 ( A ) Salı 14:30-15:15 ( A ) Salı 15:30-16:15 ( B ) Cuma 13:30-14:15 ( B ) Cuma 14:30-15:15 ( B ) Cuma 15:30-16:15 |
| 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) | Prof.Dr. Fatma Julide AKBUĞA |
| Assistant(s) | |
| Aim | To be intended the design, preparation and quality controls of the sterile dosage forms. |
| Course Content | This course contains; Demonstration,The ampoules that are prepared under normally conditions,The ampoules that are prepared under inert gase,The preparation of sterile neutral olive oil,The preparation of hormone formulations using sterile neutral olive oil,The preparation of multi-dose parenteral formulations,Perfusion and Ringer's solutions,The preparation of eye drops,Eye wash and lens solutions,Ear drops,Nasal drops,The quality controls of the parenteral dosage forms,The working principle of the autoclave.,Make-up. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| At the and of this course, the students; | ||
| 1. will be assessed the calculation methods used in the preparation of isotonic solutions. | 10, 12, 17, 19, 9 | A, D |
| 1.1. recognize the packaging materials used in the preparation of isotonic solutions. | 10, 12, 17, 19, 9 | A, D |
| 1.2. prepare isotonic solutions. | 10, 12, 17, 19, 9 | A, D |
| 2. will be prepared parenteral preparations. | 10, 12, 17, 19, 9 | A, D |
| 2.1. design ampoule and vial formulations. | 10, 12, 17, 19, 9 | A, D |
| 2.2. evaluate the quality controls of the parenteral dosage forms. | 10, 12, 17, 19, 9 | A, D |
| 2.3. categorize the parenteral dosage forms that filling under different conditions (inert gase etc.). | 10, 12, 17, 19, 9 | A, D |
| 2.4. define the excipients of the parenteral dosage forms. | 10, 12, 17, 19, 9 | A, D |
| 3. will be defined the critical issues about the preparation of ocular, otic and nasal formulations. | 10, 12, 17, 19, 9 | A, D |
| 3.1. recognise the excipients of ocular, otic and nasal formulations. | 10, 12, 17, 19, 9 | A, D |
| 3.2. explain the quality conditions related to ocular, otic and nasal formulations. | 10, 12, 17, 19, 9 | A, D |
| 4. will be defined the devices used for the preparetions and sterilizations of parenteral formulations. | 10, 12, 17, 19, 9 | A, D |
| 4.1. explain the working principle of the autoclave. | 10, 12, 17, 19, 9 | A, D |
| 4.2. list the materials that are sterilized in the oven. | 10, 12, 17, 19, 9 | A, D |
| Teaching Methods: | 10: Discussion Method, 12: Problem Solving Method, 17: Experimental Technique, 19: Brainstorming Technique, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam, D: Oral Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | Demonstration | 1,2,3,4,5,6,7,8 |
| 2 | The ampoules that are prepared under normally conditions | 1,2,3,4,5,6,7,8 |
| 3 | The ampoules that are prepared under inert gase | 1,2,3,4,5,6,7,8 |
| 4 | The preparation of sterile neutral olive oil | 1,2,3,4,5,6,7,8 |
| 5 | The preparation of hormone formulations using sterile neutral olive oil | 1,2,3,4,5,6,7,8 |
| 6 | The preparation of multi-dose parenteral formulations | 1,2,3,4,5,6,7,8 |
| 7 | Perfusion and Ringer's solutions | 1,2,3,4,5,6,7,8 |
| 8 | The preparation of eye drops | 1,2,3,4,5,6,7,8 |
| 9 | Eye wash and lens solutions | 1,2,3,4,5,6,7,8 |
| 10 | Ear drops | 1,2,3,4,5,6,7,8 |
| 11 | Nasal drops | 1,2,3,4,5,6,7,8 |
| 12 | The quality controls of the parenteral dosage forms | 1,2,3,4,5,6,7,8 |
| 13 | The working principle of the autoclave. | 1,2,3,4,5,6,7,8 |
| 14 | Make-up | 1,2,3,4,5,6,7,8 |
| Resources |
| 1-Lecture notes, powerpoint presentations, relevant web pages will be given to students. 2) Alpmen G, Altınkurt T, Bergişadi N, Topaloğlu Y, Tunçel T, Araman A, Yener G, Özsoy Y,‘Farmasötik Teknoloji ve Kozmetoloji Laboratuvar Kitabı’ AB Ofset, İstanbul, 2000.Bozkır A, 3) Karataş A, Hasçiçek C, Canefe K, Kılıçarslan M, Tarımcı N, Yüksel N, Gönül N,Özdemir N, Baykara T, Kılınç-Şen T, Çomoğlu T, ‘Farmasötik Teknoloji Deneysel Uygulamalar Kitabı’ Ankara Üniversitesi Eczacılık Fakültesi Yayınları. 4) Türk Farmakopesi (TF 2017) 5) Tıbbi ve Kozmetik Formüller (Prof. Dr. Kasım Cemal Güven) 2020 6) Martindale-the Extra Pharmacopoeia 7) USP United States Pharmacopoeia 32 8) European Pharmacopoeia 10 |
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 | 60 | |
| Rate of Final Exam to Success | 40 | |
| 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 | 10 | 1 | 10 | |||
| Term Project | 0 | 0 | 0 | |||
| Presentation of Project / Seminar | 0 | 0 | 0 | |||
| Quiz | 10 | 1 | 10 | |||
| Midterm Exam | 1 | 8 | 8 | |||
| General Exam | 1 | 16 | 16 | |||
| Performance Task, Maintenance Plan | 0 | 0 | 0 | |||
| Total Workload(Hour) | 86 | |||||
| Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(86/30) | 3 | |||||
| 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 LAB.III | PHA4114869 | Fall Semester | 0+3 | 1,5 | 3 |
| Course Program | ( A ) Salı 13:30-14:15 ( A ) Salı 14:30-15:15 ( A ) Salı 15:30-16:15 ( B ) Cuma 13:30-14:15 ( B ) Cuma 14:30-15:15 ( B ) Cuma 15:30-16:15 |
| 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) | Prof.Dr. Fatma Julide AKBUĞA |
| Assistant(s) | |
| Aim | To be intended the design, preparation and quality controls of the sterile dosage forms. |
| Course Content | This course contains; Demonstration,The ampoules that are prepared under normally conditions,The ampoules that are prepared under inert gase,The preparation of sterile neutral olive oil,The preparation of hormone formulations using sterile neutral olive oil,The preparation of multi-dose parenteral formulations,Perfusion and Ringer's solutions,The preparation of eye drops,Eye wash and lens solutions,Ear drops,Nasal drops,The quality controls of the parenteral dosage forms,The working principle of the autoclave.,Make-up. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| At the and of this course, the students; | ||
| 1. will be assessed the calculation methods used in the preparation of isotonic solutions. | 10, 12, 17, 19, 9 | A, D |
| 1.1. recognize the packaging materials used in the preparation of isotonic solutions. | 10, 12, 17, 19, 9 | A, D |
| 1.2. prepare isotonic solutions. | 10, 12, 17, 19, 9 | A, D |
| 2. will be prepared parenteral preparations. | 10, 12, 17, 19, 9 | A, D |
| 2.1. design ampoule and vial formulations. | 10, 12, 17, 19, 9 | A, D |
| 2.2. evaluate the quality controls of the parenteral dosage forms. | 10, 12, 17, 19, 9 | A, D |
| 2.3. categorize the parenteral dosage forms that filling under different conditions (inert gase etc.). | 10, 12, 17, 19, 9 | A, D |
| 2.4. define the excipients of the parenteral dosage forms. | 10, 12, 17, 19, 9 | A, D |
| 3. will be defined the critical issues about the preparation of ocular, otic and nasal formulations. | 10, 12, 17, 19, 9 | A, D |
| 3.1. recognise the excipients of ocular, otic and nasal formulations. | 10, 12, 17, 19, 9 | A, D |
| 3.2. explain the quality conditions related to ocular, otic and nasal formulations. | 10, 12, 17, 19, 9 | A, D |
| 4. will be defined the devices used for the preparetions and sterilizations of parenteral formulations. | 10, 12, 17, 19, 9 | A, D |
| 4.1. explain the working principle of the autoclave. | 10, 12, 17, 19, 9 | A, D |
| 4.2. list the materials that are sterilized in the oven. | 10, 12, 17, 19, 9 | A, D |
| Teaching Methods: | 10: Discussion Method, 12: Problem Solving Method, 17: Experimental Technique, 19: Brainstorming Technique, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam, D: Oral Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | Demonstration | 1,2,3,4,5,6,7,8 |
| 2 | The ampoules that are prepared under normally conditions | 1,2,3,4,5,6,7,8 |
| 3 | The ampoules that are prepared under inert gase | 1,2,3,4,5,6,7,8 |
| 4 | The preparation of sterile neutral olive oil | 1,2,3,4,5,6,7,8 |
| 5 | The preparation of hormone formulations using sterile neutral olive oil | 1,2,3,4,5,6,7,8 |
| 6 | The preparation of multi-dose parenteral formulations | 1,2,3,4,5,6,7,8 |
| 7 | Perfusion and Ringer's solutions | 1,2,3,4,5,6,7,8 |
| 8 | The preparation of eye drops | 1,2,3,4,5,6,7,8 |
| 9 | Eye wash and lens solutions | 1,2,3,4,5,6,7,8 |
| 10 | Ear drops | 1,2,3,4,5,6,7,8 |
| 11 | Nasal drops | 1,2,3,4,5,6,7,8 |
| 12 | The quality controls of the parenteral dosage forms | 1,2,3,4,5,6,7,8 |
| 13 | The working principle of the autoclave. | 1,2,3,4,5,6,7,8 |
| 14 | Make-up | 1,2,3,4,5,6,7,8 |
| Resources |
| 1-Lecture notes, powerpoint presentations, relevant web pages will be given to students. 2) Alpmen G, Altınkurt T, Bergişadi N, Topaloğlu Y, Tunçel T, Araman A, Yener G, Özsoy Y,‘Farmasötik Teknoloji ve Kozmetoloji Laboratuvar Kitabı’ AB Ofset, İstanbul, 2000.Bozkır A, 3) Karataş A, Hasçiçek C, Canefe K, Kılıçarslan M, Tarımcı N, Yüksel N, Gönül N,Özdemir N, Baykara T, Kılınç-Şen T, Çomoğlu T, ‘Farmasötik Teknoloji Deneysel Uygulamalar Kitabı’ Ankara Üniversitesi Eczacılık Fakültesi Yayınları. 4) Türk Farmakopesi (TF 2017) 5) Tıbbi ve Kozmetik Formüller (Prof. Dr. Kasım Cemal Güven) 2020 6) Martindale-the Extra Pharmacopoeia 7) USP United States Pharmacopoeia 32 8) European Pharmacopoeia 10 |
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 | 60 | |
| Rate of Final Exam to Success | 40 | |
| Total | 100 | |