Description of Individual Course Units
Course Unit CodeCourse Unit TitleType of Course UnitYear of StudySemesterNumber of ECTS Credits
300004552008PHARMACEUTICAL TECHNOLOGY-IIICompulsory476
Level of Course Unit
First Cycle and Second Cycle
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
1To 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
2To be able to demonstrate the contamination
3To be able to classify various drug incompatibilities and avoid incompatibility
4To be able to list medical devices and comprehend the preparation methods and conduct suitability tests
5To be able to describe isotonic and isohydric solutions and comprehend their properties, to be able to evaluate the solvents used in injectable preparations
6To comprehend the preparation methods and calculations of injectable preparations and to be able to prepare them in practice
7To be able to prepare infusion and hemodialysis solutions and comprehend the preparation techniques.
8To comprehend the basic properties of nasal and otic preparations and to be able to prepare them in practice.
9To 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
10To 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
WeekTheoreticalPracticeLaboratory
1Isotonic and isohydric solutionsReading and searching papers
2Isotonicity and calculationsPreparation 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)
3Definition of injectable preparations, Solvents involvedPreparation of triamcinolone acetonide injection or propofol injection
4Process on injectable preparationsPreparation of flacon (including floconazole solution or chloramphenicol lyophiylized powder) Preparation of gentamycine sulphate flacon and to adjust the children dose
5Infusion solutions, Hemodialysis solutionsPreparation of correction of electrolyte balance, nutritive (dextrose solution), increasing of plasma volüme (dextrane solution), dialysis (concentrated hemodialysis solution) or irrigation (mannitol solution)
6Ophthalmic preparations: definition, required properties Preparation of atrophine sulphate eye drop, pilocarpine or ciprofloxacine eye drops
7The types of contact lenses and their solutions Preparation of multipurpose lens solution Preparation of artificial tears
8Otic and nasal preparations Preparation of oxymetazoline hydrochloride nasal drop or momethasone furoate spray Preparation of gentamycine or ofloxacine ear drop
9Definition of sterilization, Sterilization methods Sterilization of injectable formulations with autoclave method and boiling water bath method
10Sterilization methodsSterlization of eye drops with glass filter and membrane filters
11ContaminationReading and searching papers
12Stability, Stability testsAspirin accelerated stability test
13MIDTERM EXAM
14IncompatibilityReading and searching papers
15Medical devicesReading and searching papers
16FINAL 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
Term (or Year) Learning ActivitiesQuantityWeight
Midterm Examination1100
SUM100
End Of Term (or Year) Learning ActivitiesQuantityWeight
Final Sınavı1100
SUM100
Term (or Year) Learning Activities40
End Of Term (or Year) Learning Activities60
SUM100
Language of Instruction
Turkish
Work Placement(s)
None
Workload Calculation
ActivitiesNumberTime (hours)Total Work Load (hours)
Midterm Examination11.51.5
Final Examination12.52.5
Attending Lectures14342
Practice18118
Laboratory10330
Criticising Paper5210
Individual Study for Mid term Examination13030
Individual Study for Final Examination14040
TOTAL WORKLOAD (hours)174.0
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* Contribution Level : 1 Very low 2 Low 3 Medium 4 High 5 Very High
 
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