PRODUCTION OF CRUDE DRUGS

ECZ336

Course Code: ECZ336
Semester: -
Theory+Practice: 2 + 0
ECTS: 2

Course Type

Elective Course

Course Level

Bachelor's Degree

Year of Study

Semester

ECTS

Name of Lecturer(s)

Professor Selma Saraç Tarhan

Learning Outcomes

At the end of this course, the students;

Knows the basic approaches of pharmaceutical raw material production and their application to drug synthesis.

Mode of Delivery

Face to face

Prerequisites

Recommended Optional Programme Components

None

Course Description

Fundamentals 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

WEEK	TOPICS
1^st Week	Fundamentals of industrial scale production
2^nd Week	Lab scale productions scale up and pilot production systems, unit processes
3^rd Week	Reactors and their constituents
4^th Week	Material information
5^th Week	Weighing, mixing, heating and cooling
6^th Week	Filtering and drying (vacuum devices, centrifuges, pumps and dryers)
7^th Week	Extraction, distilation, condensation
8^th Week	Midterm exam
9^th Week	Selection of materials used in pharmaceutical raw material production. Water and energy.
10^th Week	Materials used in pharmaceutical raw materials production
11^th Week	Materials used in the production of pharmaceutical raw materials (ferrous and non-ferrous materials)
12^th Week	Drug master file (DMF) content
13^th Week	Pharmaceutical raw materials produced in Turkey
14^th Week	Raw material synthesis examples

Recommended or Required Reading

1. 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 Methods

Lecture
Questions/Answers
Problem Solving
Discussion

Assessment Methods and Criteria

	Quantity	Percentage (%)
Mid-term	1	40
Total(%)		40
Contribution of In-term Studies to Overall Grade(%)		40
Contribution of Final Examination to Overall Grade(%)		60
Total(%)		100

ECTS Allocated Based on Student Workload

Activities	Quantity	Duration (Hour)	Total Workload (Hour)
Midterm exam	1	1	1
Preparation for Quiz	0	0	0
Individual or group work	14	1	14
Preparation for Final exam	1	10	10
Course hours	14	2	28
Preparation for Midterm exam	1	5	5
Laboratory (including preparation)	0	0	0
Final exam	1	2	2
Homework	0	0	0
Total Work Load			60
Total Work Load / 30 (h)			2
ECTS Credit of the Course			2

Language of Instruction

Turkish

Work Placement(s)

Programme Qualifications / Learning Outcomes

	LO1
K1
K2
K3
K4
K5	X
K6
K7	X
K8
K9
K10
K11
K12
K13
K14
K15
K16