Development of Pharmaceutical Products - GAF320
Title: Vývoj léčivého přípravku
Guaranteed by: Department of Pharmaceutical Technology (16-16210)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2021
Semester: winter
Points: 0
E-Credits: 3
Examination process: winter s.:
summer s.:written
Hours per week, examination: winter s.:0/16, C [HS]
summer s.:0/16, C+Ex [HS]
Capacity: winter:unknown / unknown (5)
summer:unknown / unknown (5)
Min. number of students: unlimited
4EU+: no
Virtual mobility / capacity: no
Key competences:  
State of the course: not taught
Language: English
Teaching methods: full-time
Level:  
Is provided by: GF320
Note: course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: doc. PharmDr. Zdeňka Šklubalová, Ph.D.
Co-requisite : GAF346
Interchangeability : GAF379
Is interchangeable with: GAF288, GF288
In complex pre-requisite: GAF1003
Examination dates   Schedule   
Annotation -
The elective subject in the 4th section of study of Pharmacy for specialization in Pharmaceutical Technology. The subject is related to the subject Pharmaceutical Technology. The aim is to enlarge the knowledge in the development and formulation of the pharmaceutical preparation including choice of active substance, dosage form, excipients and final evaluation of the product Topics: development process and methods used, API characterization methods, modified release, evaluation of the product, bioequivalency
Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (19.12.2017)
Course completion requirements -

For the credit  100% presence at lectures and seminars

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (19.12.2017)
Literature -

Obligatory:

  • Komárek, Pavel, Rabišková, Miloslava. Galenika. Praha: Galén, 2006, 399 s. ISBN 80-7262-423-7.

Recommended:

  • Swarbrick, James, (ed.). Encyclopedia of pharmaceutical technology. Boca Raton: CRC Press, 2013, s. ISBN 978-18-418-4819-8.

  • Gad, Shayne C., (ed.). Pharmaceutical manufacturing handbook : production and processes. Hoboken, N.J.: John Wiley & Sons, 2008, s. ISBN 978-0-470-25958-0.

Last update: prepocet_literatura.php (19.09.2024)
Teaching methods -

lectures and seminars

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (19.12.2017)
Requirements to the exam -

The subject is concluded by passing the written exam.

≥75% correct in test in necessary

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (19.12.2017)
Syllabus -

Syllabus

  • The description of development process and methods used, development phases, overview of basic techniques

  • selection of API, API characterization methods

  • Backward engineering – analysis of original product

  • Development of HPLC method, dissolution studies

  • Formulation process, BCS classification systém, choice of excipients

  • Tableting, coating, special technologies

  • Modified release

  • Evaluation of the product, bioequivalency

 

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (19.12.2017)
Learning resources -

web FaF:

https://intranet.faf.cuni.cz/Study-materials/KFT/?path=industrial+production

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (19.12.2017)