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Description of Individual Course Units| Course Unit Code | Course Unit Title | Type of Course Unit | Year of Study | Semester | Number of ECTS Credits | | 300004552008 | PHARMACEUTICAL TECHNOLOGY-III | Compulsory | 4 | 7 | 6 |
| | Level of Course Unit | | First Cycle and Second Cycle | | Language of Instruction | | Turkish | | Objectives of the Course | | The objectives of this course are, to achieve that students could: define parenteral preparations, other sterile solutions and dialysis solutions, classify them, demonstrate related physical and physiological concepts, explain all ingredients including excipients, comprehend the preparation techniques, design and prepare them, understand all the equations involved and solve the problems, priority of isotonicity, comprehend the mechanism of sterilization methods, know the sterilization techniques, make a formulation sterile, evaluate the control tests conducted on the final product, explain on the factors affecting the stability of these systems and evaluate them with the techniques involved, understand what a medical device is, know the basic materials and preparation techniques | | Name of Lecturer(s) | | Prof. Dr. Gökhan Ertan, Prof. Dr. Özgen Özer, Prof. Dr. Ferhan Sevgi, Prof. Dr. Esra Baloğlu, Prof. Dr. Yeşim Karasulu, Doç. Dr. Işık Özgüney, Doç. Dr. Mine Özyazıcı, Yard. Doç. Dr. Mesut Arıcı, Doç. Dr. Sinem Yaprak Karavana, Doç. Dr. Evren Homan Gökçe, Doç. Dr. Emel Öykü Çetin Uyanıkgil, Doç. Dr. İpek Eroğlu | | Learning Outcomes | | 1 | To be able to define drug stability concept and to be able to list the factors affecting drug stability and to be able to evaluate the stability of a drug | | 2 | To be able to demonstrate the contamination | | 3 | To be able to classify various drug incompatibilities and avoid incompatibility | | 4 | To be able to list medical devices and comprehend the preparation methods and conduct suitability tests | | 5 | To be able to describe isotonic and isohydric solutions and comprehend their properties, to be able to evaluate the solvents used in injectable preparations | | 6 | To comprehend the preparation methods and calculations of injectable preparations and to be able to prepare them in practice | | 7 | To be able to prepare infusion and hemodialysis solutions and comprehend the preparation techniques. | | 8 | To comprehend the basic properties of nasal and otic preparations and to be able to prepare them in practice. | | 9 | To be able to explain the structure of ophthalmic solutions and to be able to prepare them, to be able to classify contact lenses and explain the ingredients of lens preservation solutions | | 10 | To be able to define sterility and to be able to evaluate its efficiency after determining appropriate sterilization method by involved tests. |
| | Mode of Delivery | | Face to Face | | Prerequisites and co-requisities | | None | | Recommended Optional Programme Components | | To attend the final exam, students have to be successful in the laboratory practice | | Course Contents | | Isotonic and isohydric solutions and calculations, Definition of injectable preparations, Solvents involved, Infusion solutions, Hemodialysis solutions, Ophthalmic preparations: definition, required properties, The types of contact lenses and their solutions, Otic and nasal preparations, Definition of sterilization, Sterilization methods, Contamination, Stability, Stability Tests, Incompatibility, Medical devices | | Weekly Detailed Course Contents | |
| 1 | Isotonic and isohydric solutions | Reading and searching papers | | | 2 | Isotonicity and calculations | Preparation of amiodarone injection or ondansetrone injection, diclofenac injection or thiocolchicoside injection, pheniramine maleate injection or adrenaline injection (Using Freeze Drying Point or Sodium Chloride Equivalent Methods) | | | 3 | Definition of injectable preparations, Solvents involved | Preparation of triamcinolone acetonide injection or propofol injection | | | 4 | Process on injectable preparations | Preparation of flacon (including floconazole solution or chloramphenicol lyophiylized powder)
Preparation of gentamycine sulphate flacon and to adjust the children dose | | | 5 | Infusion solutions, Hemodialysis solutions | Preparation of correction of electrolyte balance, nutritive (dextrose solution), increasing of plasma volüme (dextrane solution), dialysis (concentrated hemodialysis solution) or irrigation (mannitol solution) | | | 6 | Ophthalmic preparations: definition, required properties | Preparation of atrophine sulphate eye drop, pilocarpine or ciprofloxacine eye drops | | | 7 | The types of contact lenses and their solutions | Preparation of multipurpose lens solution
Preparation of artificial tears | | | 8 | Otic and nasal preparations | Preparation of oxymetazoline hydrochloride nasal drop or momethasone furoate spray
Preparation of gentamycine or ofloxacine ear drop | | | 9 | Definition of sterilization, Sterilization methods | Sterilization of injectable formulations with autoclave method and boiling water bath method | | | 10 | Sterilization methods | Sterlization of eye drops with glass filter and membrane filters | | | 11 | Contamination | Reading and searching papers | | | 12 | Stability, Stability tests | Aspirin accelerated stability test | | | 13 | MIDTERM EXAM | | | | 14 | Incompatibility | Reading and searching papers | | | 15 | Medical devices | Reading and searching papers | | | 16 | FINAL EXAM | | |
| | Recommended or Required Reading | | 1. Advanced Pharmaceutics: Physicochemical Principles, Cherng-ju Kim, Mar. 26, 2004
2. Aulton's Pharmaceutics: The Design and Manufacture of Medicines, Michael E. Aulton, Kevin Taylor, Nov. 1, 2007
3. Cooper and Gunn's Tutorial Pharmacy, S. J. Carter, Dec. 1, 2005
4. Drug Safety Assessment in Clinical Trials (Statistics: A Series of Textbooks and Monographs) G. S. Gilbert, Jul 14, 1993
5. Drug Stability: Principles and Practices (Drugs and the Pharmaceutical Sciences), Jens T. Carstensen, Christopher Rhodes, Aug 15, 2000
6. Encyclopedia of pharmaceutical technology volume 1-5
7. European Pharmacopoeia 6.0, Council of Europe, Jul 23, 2007
8. Freeze-Drying/Lyophi... Of Pharmaceutical & Biological Products, Second Edition: Revised And Expanded (Drugs and the Pharmaceutical Sciences), Louis Rey, Joan C. May, Jan 21, 2004
9. Injectable Dispersed Systems: Formulation, Processing and Performance (Drugs and the Pharmaceutical Sciences), Diane J. Burgess, May 23, 2005
10. Microbial Contamination Control in the Pharmaceutical Industry (Drugs and the Pharmaceutical Sciences), Luis Jimenez, Aug 30, 2004
11. Ophthalmic Drug Delivery Systems, Second Edition: Second Edition, Revised And Expanded (Drugs and the Pharmaceutical Sciences) by Ashim K. Mitra, Mar 25, 2003
12. Parenteral Preparatlar Teknolojisi, Murat Şumnu, Hacettepe Yayınları, 2009
13. Pharmaceutical Dosage Forms: parenteral Medications, Vol. 1-2, Herbert Lieberman, Leon Lachman, Joseph B. Schwartz, Jan 15, 1993
14. Pharmaceutical Process Validation: An International (Drugs and the Pharmaceutical Sciences) by Robert A. Nash, Alfred H. Wachter, Mar 27, 2003
15. Pharmaceutical Product Development: In Vitro-In Vivo Correlation (Drugs and the Pharmaceutical Sciences), Dakshina Murthy Chilukuri, Gangadhar Sunkara, David Young, Feb 12, 2007
16. Prodrugs (Drugs and the Pharmaceutical Sciences), Sloan, Mar 17, 1992
17. Stability testing of drug products, 1987, Wolfgang Grimm
18. The Complete Drug Reference, 1992, United States Pharmacopeial Convention Inc. Permission granted, Consumer Reports Books
19. Transnasal Systemic Medications: Fundamentals, Developmental Concepts and Biomedical Assessments, Yie W. Chien Mar. 1985
20. Validation Fundamentals: How To, What To, When To Validate, William Gibson, Keith Powell-Evans, Apr. 30, 1998
21. Farmasötik Teknoloji, Temel konular ve dozaj şekilleri, A. Z. Gürsoy, Kontrollü Salım Sistemleri Derneği, 2004
22. Modern Farmasötik Teknoloji, F. Acartürk, İ. Ağabeyoğlu, N. Çelebi, T. Değim, Z. Değim, T. Doğanay, S. Takka, F. Tırnaksız, Türk Eczacıları Birliği Eczacılık Akademisi Yayını, 2006
23. Clarke's Isolation and Identification of Drugs, Moffat, Jan 1986 | | Planned Learning Activities and Teaching Methods | | Activities are given in detail in the section of "Assessment Methods and Criteria" and "Workload Calculation" | | Assessment Methods and Criteria | |
| Midterm Examination | 1 | 100 | | SUM | 100 | |
| Final Sınavı | 1 | 100 | | SUM | 100 | | Term (or Year) Learning Activities | 40 | | End Of Term (or Year) Learning Activities | 60 | | SUM | 100 |
| | Work Placement(s) | | None |
| | Workload Calculation | |
| Midterm Examination | 1 | 1.5 | 1.5 | | Final Examination | 1 | 2.5 | 2.5 | | Attending Lectures | 14 | 3 | 42 | | Practice | 18 | 1 | 18 | | Laboratory | 10 | 3 | 30 | | Criticising Paper | 5 | 2 | 10 | | Individual Study for Mid term Examination | 1 | 30 | 30 | | Individual Study for Final Examination | 1 | 40 | 40 | |
| Contribution of Learning Outcomes to Programme Outcomes | | LO1 | 5 | 5 | 3 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 4 | 5 | 5 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 5 | | LO2 | 5 | 5 | 3 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 4 | 5 | 5 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 5 | | LO3 | 5 | 5 | 3 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 4 | 5 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 5 | 5 | | LO4 | 5 | 5 | 3 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 4 | 5 | 5 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 5 | | LO5 | 5 | 5 | 3 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 4 | 5 | 5 | 5 | 4 | 5 | 5 | 5 | 5 | 4 | 4 | | LO6 | 5 | 5 | 3 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 4 | 5 | 5 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 5 | | LO7 | 5 | 5 | 3 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 4 | 5 | 5 | 5 | 3 | 4 | 5 | 5 | 5 | 5 | 5 | | LO8 | 5 | 5 | 3 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 4 | 5 | 5 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 5 | | LO9 | 5 | 5 | 3 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 4 | 5 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 5 | 5 | | LO10 | 5 | 5 | 3 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 4 | 5 | 5 | 5 | 3 | 5 | 5 | 5 | 5 | 5 | 5 |
| | * Contribution Level : 1 Very low 2 Low 3 Medium 4 High 5 Very High |
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| Ege University, Bornova - İzmir / TURKEY • Phone: +90 232 311 10 10 • e-mail: intrec@mail.ege.edu.tr |
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