The aim of studying and bibliography

The main aim of study: Presentation of the basic and most important requirement on the raw materials for medicinal products.

The general information about the module: The module is implemented in sixth semester engineering and includes 15 h lectures and 30 h laboratory exercises. It ends with a test for the practical and lecture part

Teaching materials: Skrócone materiały wykładowe w postaci prezentacji i/lub kserokopii.

Bibliography required to complete the module

Bibliography used during lectures

1	S.C. Sweetman Martindale	The Complete Drug Reference	Pharmaceutical Press, 36 Ed..	2009
2	R.C. Rowe, P.J. Shesky, P. J. Weller, Handbook of Pharmaceutical Excipients,	Handbook of Pharmaceutical Excipients,	Pharmaceutical Press and American Pharmaceutical Association, London, Chicago, Ed1-4.	1986
3	A. Kowal, M. Świderska-Bróż	Oczyszczanie wody	PWN.	2000

Bibliography used during classes/laboratories/others

1

Instrukcje do zajęć oraz instrukcje wewnętrzne zakładu farmaceutycznego

.

Bibliography to self-study

1		http://www.pharmainfo.net/excipients	.
2		http://www.ipec.gov/	.

Basic requirements in category knowledge/skills/social competences

Formal requirements: Registration for the current semester.

Basic requirements in category knowledge: Basic knowledge of general, physical, analytical and organic chemistry.

Basic requirements in category skills: The ability to select material and methodology of the study.

Basic requirements in category social competences: The ability to cooperate and work in a group.

Module outcomes

MEK	The student who completed the module	Types of classes / teaching methods leading to achieving a given outcome of teaching	Methods of verifying every mentioned outcome of teaching	Relationships with KEK	Relationships with PRK
01	He knows the processes and operations related to the technological production of the medicinal product.	lecture	written test	K_U06+ K_K01+	P6S_KK P6S_UW
02	He knows the ways of verification of raw materials, including active substance and excipients, for their suitability for the production of medicinal products.	laboratory	written report	K_U07+ K_K02+	P6S_KO P6S_KR P6S_UW
03	He/she knows the criteria for the selection of analytical methods for the raw material for the manufacture of the medicinal product including the active substance and excipients.	lecture	written report	K_W07+	P6S_WG

Attention: Depending on the epidemic situation, verification of the achieved learning outcomes specified in the study program, in particular credits and examinations at the end of specific classes, can be implemented remotely (real-time meetings).

The syllabus of the module

Sem.	TK	The content	realized in	MEK
4	TK01	The use of pharmaceutical excipients. Requirements for auxiliary substances. Important excipients and their characteristics. Solvents used in the pharmaceutical industry (characteristics, application, safety of working with organic solvents). Packaging materials. Active substances in the production of medicinal products. Purification, handling procedures and quality assessment of air and water in the pharmaceutical industry.	W01-W07	MEK01 MEK02 MEK03
4	TK02	1. Carboxymethylcellulose synthesis 2. Synthesis of methyl p-hydroxybenzoate 3. Synthesis of calcium lactate 4. Synthesis of chlorobutanol 5. Testing and assessment of water quality.	L01-L06	MEK01 MEK02 MEK03

The student's effort

The type of classes	The work before classes	The participation in classes	The work after classes
Lecture (sem. 4)	The preparation for a test: 10.00 hours/sem.	contact hours: 15.00 hours/sem.	complementing/reading through notes: 4.00 hours/sem. Studying the recommended bibliography: 10.00 hours/sem.
Laboratory (sem. 4)	The preparation for a Laboratory: 8.00 hours/sem. The preparation for a test: 8.00 hours/sem.	contact hours: 30.00 hours/sem.	Finishing/Making the report: 8.00 hours/sem.
Advice (sem. 4)	The preparation for Advice: 1.00 hours/sem.	The participation in Advice: 1.00 hours/sem.
Credit (sem. 4)	The preparation for a Credit: 8.00 hours/sem.	The written credit: 1.00 hours/sem.

The way of giving the component module grades and the final grade

The type of classes	The way of giving the final grade
Lecture	Written test covering the entire range of lecture with the weight of the grade proportional to hours of lecture of individual teacher.
Laboratory	The evaluation of the colloquium and reports on the activities carried out at the university.
The final grade	The final note (OK) is calculated according to the formula: OK = (OW + OL)/2

Sample problems

Required during the exam/when receiving the credit
(-)

Realized during classes/laboratories/projects
(-)

Others
(-)

Can a student use any teaching aids during the exam/when receiving the credit : no

The contents of the module are associated with the research profile: no