Pharmaceutical Technology II - GF346
Title: Farmaceutická technologie II
Guaranteed by: Department of Pharmaceutical Technology (16-16210)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2024
Semester: winter
Points: 0
E-Credits: 12
Examination process: winter s.:oral
Hours per week, examination: winter s.:56/70, C+Ex [HS]
Capacity: unlimited / 180 (unknown)
Min. number of students: unlimited
4EU+: no
Virtual mobility / capacity: no
Key competences:  
State of the course: taught
Language: Czech
Teaching methods: full-time
Level:  
Note: deregister from the exam date if a requisite was not fulfilled
Guarantor: doc. PharmDr. Zdeňka Šklubalová, Ph.D.
Comes under: 4.ročník 2023/24 Farmacie (FAR)
4.ročník 2024/25 Farmacie
Pre-requisite : GF344
Is co-requisite for: GF327, GF352, GF251, GF320, GF505, GF379, GF318, GF378
Is pre-requisite for: GF363
Is interchangeable with: GF188
Examination dates   WS schedule   
Annotation -
The Pharmaceutical Technology II (PhT2) course focuses on the production of technologically demanding, primarily industrially produced, dosage forms (solid dosage forms, sterile dosage forms, aerodispersions, particulate carriers for the delivery of active substances, vaccines, radiopharmaceuticals, and others). It includes topics focused on understanding the structure of drug delivery systems with modified release ((prolonged, delayed, pulsatile release, and targeted API distribution) and API release mechanisms.<br> Practical training allows students to acquire additional skills necessary for magistraliter preparation of medicinal products in pharmacies, correct application of pharmaceutical calculations required for preparation, including API dose control, adjustment of the preparation and its labeling, possibilities of product stabilization and determination of shelf life. It also includes seminar topics deepening knowledge of specific procedures used in the formulation, preparation or evaluation of medicinal products.
Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (17.03.2025)
Course completion requirements -

The subject PhT2 is completed with a credit. The exam (written) in the subject Pharmaceutical Technology II is common with the subject PhT1. The course is concluded with a final oral state exam.

The following conditions conditions should be fulfilled for credit:

Completing practical exercises to the extent prescribed by the study plan.

100% participation in classes is required

proper keeping of protocols from the practical training

75% of correct answers in each of the final tests

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (17.03.2025)
Literature -

Obligatory:

  • . . In Akers, Michael J.. Sterile drug products : formulation, packaging, manufacturing, and quality . New York: Informa Healthcare, 2010, s. -. ISBN 978-084933993-6..
  • . . In Šklubalová, Zdeňka. Základní praktická cvičení z farmaceutické technologie . Praha: Univerzita Karlova, Nakladatelství Karolinum, 2020, s. -. ISBN 978-80-246-4561-2..
  • . . In Šklubalová, Zdeňka Vraníková, Barbora. Oční přípravky : (Ocularia, Ophthalmica . Praha: Maxdorf, 2018, s. -. ISBN 978-80-7345-572-9..
  • . . In Swarbrick, James, (ed.). Encyclopedia of pharmaceutical technology . New York: Informa Healthcare, 2007, s. -. ISBN 0-8493-9399-X..
  • . . In Mužíková, Jitka. Speciální praktická cvičení z farmaceutické technologie . Praha: Karolinum, 2019, s. -. ISBN 978-80-246-4275-8..

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

lecture

seminar

practical training

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (04.12.2021)
Requirements to the exam -
The confirmation of credits
Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (17.03.2025)
Syllabus -

The subject Pharmaceutical Technology II (PhT2) builds on the knowledge and skills acquired in the subject Pharmaceutical Technology I and its preceding courses.

Based on the acquired knowledge and skills, students will:

• select and assess the suitability of excipients in the formulation of solid dosage forms in relation to their granulometric and bulk characteristics and compressibility, explain the principles of methods used for the production of solid dosage forms; evaluate the risks of the production process with regard to ensuring dose uniformity;

• explain the principles of methods used for the production of sterile dosage forms, assess their importance for achieving the quality of the final product; propose a suitable procedure for assessing the quality of sterile dosage forms with regard to its safety;

• perform bacterial retentive filtration;

• explain the principles of aerodispersion formation, propose appropriate quality tests in regard to ensuring dose uniformity;

• explain the principles of the formation of dosage forms with prolonged, delayed, pulsatile release and targeted API distribution;

• explain the importance/role of excipients used in dosage forms with immediate and modified API release using examples; characterize particulate carriers for the administration of medicinal substances;

• propose the design of dosage forms with modified API release with regard to the application and therapeutic goal.

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (17.03.2025)
Learning resources -

Web FaF:

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

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (04.12.2021)
Learning outcomes -

The subject Pharmaceutical Technology II (PhT2) builds on the knowledge and skills acquired in the subject Pharmaceutical Technology I and its preceding courses.

After completing the subject, students will be able to use the following terms (including their commonly used abbreviations) in the correct context towards the preparation, production and quality requirements of medicinal products: registered LP, GMP, documentation and validation in pharmaceutical production, stability and stabilization of medicinal product, production of solid dosage forms, production of sterile LP, types of API release from dosage forms, mechanisms of API release from dosage forms, principles of production of dosage forms with prolonged, delayed, pulsatile and targeted API release.

Learning outcomes:

Based on the acquired knowledge and skills, students will:

• select and assess the suitability of excipients in the formulation of solid dosage forms in relation to their granulometric and bulk characteristics and compressibility, explain the principles of methods used for the production of solid dosage forms; evaluate the risks of the production process with regard to ensuring dose uniformity;

• explain the principles of methods used for the production of sterile dosage forms, assess their importance for achieving the quality of the final product; propose a suitable procedure for assessing the quality of sterile dosage forms with regard to its safety;

• perform bacterial retentive filtration;

• explain the principles of aerodispersion formation, propose appropriate quality tests in regard to ensuring dose uniformity;

• explain the principles of the formation of dosage forms with prolonged, delayed, pulsatile release and targeted API distribution;

• explain the importance/role of excipients used in dosage forms with immediate and modified API release using examples; characterize particulate carriers for the administration of medicinal substances;

• propose the design of dosage forms with modified API release with regard to the application and therapeutic goal.

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (17.03.2025)