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| ECZ4036 | Pharmaceutical Technology Laboratory - IV | 0+0+3 | ECTS:2 | | Year / Semester | Spring Semester | | Level of Course | Second Cycle | | Status | Compulsory | | Department | DEPARTMENT of PHARMACEUTICS | | Prerequisites and co-requisites | None | | Mode of Delivery | Face to face, Group study, Lab work , Practical | | Contact Hours | 14 weeks - 3 hours of laboratory per week | | Lecturer | Dr. Öğr. Üyesi Seçkin ENGİN | | Co-Lecturer | DOCTOR LECTURER Özlem ÇOBAN, | | Language of instruction | Turkish | | Professional practise ( internship ) | None | | | | The aim of the course: | | To make calculations about parenteral preparations, to learn the parameters to be careful in production
To learn sterilization methods, which method should be preferred for which product, advantages and disadvantages of methods
Stability reaction kinetics, shelf life calculation
Types of incompatibility, precautions to be taken
To have information about GMP, GCP, GLP, GRP guidelines
To learn concepts releated to bioequivalence, bioequivalence, pharmaceutical equivalent, therapeutic equivalent
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| Learning Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | LO - 1 : | Can makes calculations related to parenteral preparations, knows the parameters to be taken care of in production and necessary properties of the place of production | 5,7,9 | 1,2,4,5,6, | | LO - 2 : | Knows sterilization methods, knows which method to choose for which product and the advantages and disadvantages of the methods | 5,7,9 | 1,2,4,5,6, | | LO - 3 : | Knows the stability reaction kinetics and calculates the shelf life.
Can designs stability work according to product characteristics | 5,7,9 | 1,2,4,5,6, | | LO - 4 : | Knows the types of incompatibilities and precautions to be taken, practically prepares incompatible prescriptions | 5,7,9 | 1,2,4,5,6, | | LO - 5 : | Has information about GMP, GCP, GLP, and GRP guidlines, knows what guidelines to follow in the process until a product is released to the market | 5,7,9 | 1,2,4,5,6, | | LO - 6 : | Have knowledge about bioavailability, bioequivalence, pharmaceutical equivalent, therapeutic equivalent concepts | 5,7,9 | 1,2,4,5,6, | | CTPO : Contribution to programme outcomes, TOA :Type of assessment (1: written exam, 2: Oral exam, 3: Homework assignment, 4: Laboratory exercise/exam, 5: Seminar / presentation, 6: Term paper), LO : Learning Outcome | | |
| Definiton of parenteral products, concepts related to parenteral preparations, production technology of parenteral preparations, sterilization, packaging, quality control and validation studies
Eye, nose and ear preparations
Biotechnological products
Biopharmaceutics-Pharmacokinetics
Stability
Incompatibility
GMP,GCP and related guidlines |
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| Course Syllabus | | Week | Subject | Related Notes / Files | | Week 1 | Theoretical: Parenteral preparations, definitions, properties, related calculations
Practical: A brief description of the activities to be carried out during the semester - DEMO | | | Week 2 | Theoretical: Production technology of parenteral preparations
Practical: Ringer's Injection (USP 27), Cholera solution, Electrolyte solution
| | | Week 3 | Theoretical: Quality control studies and validation in parenteral preparations
Practical: Dextrose injection (USP 27), Menadioni injection, Lincomycin injection | | | Week 4 | Theoretical: Sterilization of parenteral preparations, Sterilization methods
Practical: Procaine-adrenaline solution for injection, Sterile neutral olive oil
| | | Week 5 | Theoretical: Packaging of parenteral preparations, properties of packaging materials
Practical: Pilocarpine HCl eye drop, Ephedrine sulphate nose drop, Benzocaine-antipyrin ear drop | | | Week 6 | Theoretical: Eye, ear and nose products
Practical: Stability test of aspirin | | | Week 7 | Theoretical: Radiopharmaceuticals, their properties and preparations methods
Practical: Industrial production of syrups | | | Week 8 | Theoretical: Biotechnology, biotechnological products, tehir stability
Practical: Industrial production of emulsions
| | | Week 9 | Midterm | | | Week 10 | Theoretical: Types of incompatibility, precautions to be taken
Practical: Industrial production of ointments | | | Week 11 | Theoretical: Stability and Reaction kinetics
Practical: Industrial production of suppositories | | | Week 12 | Theoretical: Stability and Reaction kinetics
Practical: Dissolution studies for solid dosage forms | | | Week 13 | Theoretical: Stability and Reaction kinetics
Practical: Compatible and incompatible prescriptions | | | Week 14 | Theoretical: Biopharmaceutics-Pharmacokinetics, Bioavailability-Bioequivalence
Practical: Oral project presentations | | | Week 15 | Theoretical: GMP and Quality management
Practical: Project practice studies | | | Week 16 | Final examination | | | |
| 1 | TEB-Modern Farmasötik Teknoloji | | | |
| Method of Assessment | | Type of assessment | Week No | Date | Duration (hours) | Weight (%) | | Mid-term exam | 9 | 16.04.2022 | 2 | 38 | | In-term studies (second mid-term exam) | 1
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15 | | 3 | 6 | | Quiz | 1
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15 | | 0,15 | 6 | | Laboratory exam | 16 | | 1 | 15 | | Oral exam | 1
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15 | | 0,08 | | | End-of-term exam | 14 | 06.06.2022 | 3 | 35 | | |
| Student Work Load and its Distribution | | Type of work | Duration (hours pw) | No of weeks / Number of activity | Hours in total per term | | Yüz yüze eğitim | 3 | 14 | 42 | | Laboratuar çalışması | 3 | 14 | 42 | | Arasınav için hazırlık | 2 | 7 | 14 | | Arasınav | 3 | 1 | 3 | | Kısa sınav | .15 | 13 | 1.95 | | Dönem sonu sınavı için hazırlık | 2 | 7 | 14 | | Dönem sonu sınavı | 3 | 1 | 3 | | Total work load | | | 119.95 |
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