Subjects

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Engineering in the Pharmaceutical Industry - N111014

Title:	Inženýrství farmaceutických výrob
Guaranteed by:	Department of Organic Technology (111)
Faculty:	Faculty of Chemical Technology
Actual:	from 2009 to 2012
Semester:	both
Points:	5
E-Credits:	5
Examination process:
Hours per week, examination:	2/2, C+Ex [HT]
Capacity:	winter:84 / 84 (unknown) summer:unknown / unknown (unknown)
Min. number of students:	unlimited
State of the course:	taught
Language:	Czech
Teaching methods:	full-time
Level:
Additional information:	http://předmět je vyučován pouze v zimním semestru
Note:	course can be enrolled in outside the study plan enabled for web enrollment you can enroll for the course in winter and in summer semester

Guarantor:	Hanika Jiří prof. Ing. DrSc.

Examination dates Schedule

Annotation -

The course provides knowledge of the preparation of dosage forms, which are crucial for the formulation of pharmaceutical products. Principles of liquid, semi-solid and solid dosage forms and methods for assessing their quality are explained, using chemical engineering principles and knowledge of physical chemistry and other disciplines. Particular attention is paid to particulate solids, their storage, transport, mixing, granulation and tabletting. Biotech synthesis of antibiotics in aerobic digesterare are discussed separately.

Last update: Patera Jan (01.08.2013)

Literature -

R:Perry R. H., Green D. W.,Chemical Engineer’s Handbook,McGraw Hill,New York,1997,0070498415.

R:Sajvera J.,Technologie farmaceutických výrob II,Informatorium,Praha,1993,8085427303.

A:Komárek P.,Rabišková M. a kolektiv,Technologie léků,Galén,Praha,2006,8072624237.

A:Levin M.: Pharmaceutical process scale up,Decker,New York,2002,0824706250.

A:Hanika J.,Speciální separační procesy,VŠCHT,Praha 1999,8070802421.

Last update: Patera Jan (01.08.2013)

Requirements to the exam - Czech

1. Samostatné zpracování vybrané kapitoly z probírané látky

2. Předložení protokolu o testu rozpadovosti pevné lékové formy vybraného léčiva

3. Ústní zkouška

Last update: Patera Jan (15.11.2012)

Syllabus -

1. Handling of solids, mixing, size reduction

2. Solids transport and storage

3. Drugs formulation

4. Pressure compaction of solids

5. Theory of fermentation processes

6. Growth law for micro-organism population

7. Bioreactors for aerobic processes

8. Fermentation control, micro-organism separation

9. Basic principles of sterilization

10. Small scale chemical technology

11. Optimal design and control of batch processes

12. Planning and control of batch production

13. Quality control and good manufacturing practice

14. Plant process and operation, technical excursion

Last update: Patera Jan (15.11.2012)

Learning resources -

http://tresen.vscht.cz/kot/blog/studium/bakalarske/inzenyrstvi-farmaceutickych-vyrob

Last update: Patera Jan (01.08.2013)

Learning outcomes -

Students will be able to:

Apply theoretical knowledge to specific processes used in industry.

Apply theoretical knowledge on research of processes of pharmaceutical industry, including biotechnology synthesis of antibiotics.

Analyze and combine the basic operational processes of manufacture of dosage forms in the pharmaceutical industry.

Acquire basic analytical methods for the evaluation of solid dosage forms according to the Czech Pharmacopoeia.

Last update: Patera Jan (01.08.2013)

Entry requirements - Czech

Pro zápis tohoto předmětu je nutno mít minimálně zapsán předmět N409002

Last update: SMIDOVAL (21.05.2009)

Registration requirements -

Unit Operations of Chemical Engineering I

Physical Chemistry I

Last update: Patera Jan (01.08.2013)