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COURSE UNIT TITLECOURSE UNIT CODESEMESTERTHEORY + PRACTICE (Hour)ECTS
PRODUCTION OF CRUDE DRUGS ECZ336 - 2 + 0 2

TYPE OF COURSE UNITElective Course
LEVEL OF COURSE UNITBachelor's Degree
YEAR OF STUDY-
SEMESTER-
NUMBER OF ECTS CREDITS ALLOCATED2
NAME OF LECTURER(S)-
LEARNING OUTCOMES OF THE COURSE UNIT At the end of this course, the students;
1) Knows the basic approaches of pharmaceutical raw material production and their application to drug synthesis.
MODE OF DELIVERYFace to face
PRE-REQUISITES OF THE COURSENo
RECOMMENDED OPTIONAL PROGRAMME COMPONENTNone
COURSE DEFINITIONFundamentals of industrial scale production. Lab scale productions scale up and pilot production systems, unit processes Reactors and their constituents. Material information, weighing, mixing, heating and cooling Filtering and drying (vacuum devices, centrifuges, pumps and dryers) Extraction, distilation, condensation Selection of materials used in pharmaceutical raw material production. Water and energy. Materials used in pharmaceutical raw materials productionMaterials used in the production of pharmaceutical raw materials Drug master file (DMF) content Pharmaceutical raw materials produced in Turkey.
COURSE CONTENTS
WEEKTOPICS
1st Week Fundamentals of industrial scale production
2nd Week Lab scale productions scale up and pilot production systems, unit processes
3rd Week Reactors and their constituents
4th Week Material information
5th Week Weighing, mixing, heating and cooling
6th Week Filtering and drying (vacuum devices, centrifuges, pumps and dryers)
7th Week Extraction, distilation, condensation
8th Week Midterm exam
9th Week Selection of materials used in pharmaceutical raw material production. Water and energy.
10th Week Materials used in pharmaceutical raw materials production
11th Week Materials used in the production of pharmaceutical raw materials (ferrous and non-ferrous materials)
12th Week Drug master file (DMF) content
13th Week Pharmaceutical raw materials produced in Turkey
14th Week Raw material synthesis examples
RECOMENDED OR REQUIRED READING1. Ergenç, N., Salman S., Salman, A., `Türkiyede Üretilen İlaç Etken Maddeleri? İstanbul, 1992.
2. Shreve R.N.,? Chemical Process Industries?, Mc Graw Hill 1977.
3. Smith J.C., `Unit Operations of Chemical Engineering?, Mc Graw Hill, 2000.
4. Houson, I., Process Understanding: For Scale-Up and Manufacture of Active Ingredients, Wiley-VCH Verlag GmbH & Co.KgaA, 2011.
5. Mehra, V., Pratik Kimya Mühendisliği El Kitabı? TMMOB yayınları, İstanbul 2007.
6. Shioriri, T., Izawa, K., Konoike, T., Pharmaceutical Process Chemistry ?,Wiley-VCH Verlag GmbH & Co. KgaA, 2011.
7. Shukshith K.S, N. Vishal Gupta, Water for Pharmaceutical Use, Int. J. Pharm. Sci. Rev. Res., 36(1), 2016; Article No. 35, 199-204.
8. Christina Galitsky et all, Improving Energy Efficiency in Pharmaceutical Manufacturing Operations, Part II: HVAC, Boilers and Cogeneratio, LBNL-60288 Part II, 2006.
9. Victor Sanchez et all, In-Process Control Methods for the Manufacture of APIs, Pharmaceutical Technology.
10. McCabe, W.L., Smith, J.C., Unit Operations of Chemical Engineering, McGraw Hill, 2000.
11. Groggins, P.H., Unit Processes in Organic Synthesis, McGraw Hill, 1958.
PLANNED LEARNING ACTIVITIES AND TEACHING METHODSLecture,Questions/Answers,Problem Solving,Discussion
ASSESSMENT METHODS AND CRITERIA
 QuantityPercentage(%)
Mid-term140
Total(%)40
Contribution of In-term Studies to Overall Grade(%)40
Contribution of Final Examination to Overall Grade(%)60
Total(%)100
ECTS WORKLOAD
Activities Number Hours Workload
Midterm exam111
Preparation for Quiz000
Individual or group work14114
Preparation for Final exam11010
Course hours14228
Preparation for Midterm exam155
Laboratory (including preparation)000
Final exam122
Homework000
Total Workload60
Total Workload / 302
ECTS Credits of the Course2
LANGUAGE OF INSTRUCTIONTurkish
WORK PLACEMENT(S)No
  

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