STABILITY AND LEGAL REGULATIONS IN DRUG FORMULATIONS

ECF552

Course Code: ECF552
Semester: -
Theory+Practice: 3 + 0
ECTS: 5

Course Type

Elective Course

Course Level

Master's Degree Without Thesis

Year of Study

Semester

ECTS

Name of Lecturer(s)

Learning Outcomes

At the end of this course, the students;

Learn the basic concepts about drug stability.
Know to conduct, evaluate and interpret the stability tests of active substance and finished product according to international guidelines.
Learn to calculate the shelf life of drugs.
Learns the storage conditions of drugs.
Have knowledge about good storage and distribution practices of drugs.
Use the accuire knowledge and skills in pharmaceutical industry and other institutions.

Mode of Delivery

Face to face

Prerequisites

Recommended Optional Programme Components

None

Course Description

The course cover, the review and discussion of stability tests on different dosage forms and active ingredients for the development of drug formulations, through the perspective of regulations and relevant guidelines (ICH Guidelines).

Course Contents

WEEK	TOPICS
1^st Week	Basic concepts and definitions related to stabilite
2^nd Week	International guidelines on stability tests (ICH Guideline
3^rd Week	Factors affecting the stability of drugs (temperature, light, humidity, humidity, production process
4^th Week	Preparation of stability test protocols for active substance and finished product
5^th Week	Determination of stability parameters (criterias) for different dosage forms Example: Liquid drug forms
6^th Week	Determination of stability parameters (criterias) for different dosage forms Example: Solid Drug forms
7^th Week	MID TERM EXAMINATION
8^th Week	Determination of stability parameters (criterias) for different dosage forms Example: Semi-solid drug forms
9^th Week	Microbiological stability of drugs
10^th Week	Calculation of the shelf life of drugs
11^th Week	Stability of biotechnological products
12^th Week	Stability of Cosmetics and Medical Devices
13^th Week	Good distribution practices, cold chain concept
14^th Week	Good storage practices

Recommended or Required Reading

1. Lecture notes
2. Modern Farmasötik Teknoloji, TEB Eczacılık Akademisi Yayını (Acartürk,F., Ağabeyoğlu,İ., Çelebi,N., Değim, T., Değim, Z.,Doğanay,T.,Takka,S., Tırnaksız,F.), 2007
3. Physical Pharmacy (Editör: Alfred Martin) (Lea&Febriger, ABD, 1993
4. ICH Guidelines
5. Drug Stability for Pharmaceutical Scientists, 1st Edition, Thorsteinn Loftsson, 2013.

Planned Learning Activities and Teaching Methods

Lecture
Discussion
Questions/Answers

Assessment Methods and Criteria

	Quantity	Percentage (%)
Mid-term	1	30
Assignment	2	20
Total(%)		50
Contribution of In-term Studies to Overall Grade(%)		50
Contribution of Final Examination to Overall Grade(%)		50
Total(%)		100

ECTS Allocated Based on Student Workload

Activities	Quantity	Duration (Hour)	Total Workload (Hour)
Midterm exam	0	0	0
Preparation for Quiz	0	0	0
Individual or group work	14	2	28
Preparation for Final exam	1	14	14
Course hours	14	2	28
Preparation for Midterm exam	0	0	0
Laboratory (including preparation)	0	0	0
Final exam	1	3	3
Homework	2	12	24
Presentation (including preperation)	1	14	14
Literature review	12	3	36
Total Work Load			147
Total Work Load / 30 (h)			4.9
ECTS Credit of the Course			5

Language of Instruction

Turkish

Work Placement(s)

Programme Qualifications / Learning Outcomes

	LO1	LO2	LO3	LO4	LO5	LO6
K1	X	X	X	X	X	X
K2	X	X	X	X	X	X
K3	X	X	X	X	X	X
K4
K5
K6
K7
K8	X	X	X	X	X	X