Dosage Forms II - GAPS028
Title: Dosage Forms II
Guaranteed by: Department of Pharmaceutical Technology (16-16210)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2024 to 2024
Semester: winter
Points: 0
E-Credits: 11
Examination process: winter s.:written
Hours per week, examination: winter s.:56/35, C+Ex [HS]
Capacity: unknown / unknown (unknown)
Min. number of students: unlimited
4EU+: no
Virtual mobility / capacity: no
Key competences:  
State of the course: taught
Language: English
Teaching methods: full-time
Level:  
Is provided by: GAF346
Note: deregister from the credit exam date if a requisite was not fulfilled
Guarantor: doc. PharmDr. Zdeňka Šklubalová, Ph.D.
Interchangeability : GAPS346
Is co-requisite for: GAPS006
Is interchangeable with: GAPS346
Examination dates   WS schedule   
Annotation -
The Dosage forms 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.
Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (17.03.2025)
Course completion requirements -

The subject Dosage forms 2 is completed with a credit. The exam (written) in the subject Dosage forms 2 is common with the subject Dosage forms 1. The course is concluded with a final oral state exam.

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

Obligatory:

  • Ranade, Vasant V. Cannon, John B.. Drug delivery systems. Boca Raton: CRC Press, 2011, 590 s. ISBN .

  • Allen, Loyd V. Ansel, Howard C.. Ansel's Pharmaceutical dosage forms and drug delivery systems. Philadelphia: Lippincott William nad Wilkins, 2014, 794 s. ISBN 978-1-4698-5568-4.

  • null. . In Yeo, Yoon (ed.). Nanoparticulate drug delivery systems : strategies, technologies, and applications . Hoboken: Wiley, 2013, s. -. ISBN 978-1-118-14887-7..

  • null. . In Florence, A. T. Siepmann, Jurgen (eds.). Modern pharmaceutics . New York: Informa Healthcare USA, 2009, s. -. ISBN 978-1-4200-6566-4..

  • null. . In Akers, Michael J.. Sterile drug products : formulation, packaging, manufacturing, and quality . New York: Informa Healthcare, 2010, s. -. ISBN 978-084933993-6..

  • null. . In Allen, Loyd V. (ed.). Remington : an introduction to pharmacy . London: Pharmaceutical Press, 2013, s. -. ISBN 978-0-85711-104-3..

  • null. . In Swarbrick, James, (ed.). Encyclopedia of pharmaceutical technology . New York: Informa Healthcare, 2007, s. -. ISBN 0-8493-9399-X..

Last update: Doová Lenka, Mgr., Ph.D. (21.06.2024)
Teaching methods -

lecture

seminar

practical training

Last update: Doová Lenka, Mgr., Ph.D. (21.06.2024)
Requirements to the exam -

The subject Dosage forms 2 is completed with a credit. The exam (written) in the subject Dosage forms II is common with the subject Dosage forms 1. The course is concluded with a final oral state exam

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

The subject Dosage forms II 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)
Learning resources -

Web FaF:

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

Last update: Doová Lenka, Mgr., Ph.D. (21.06.2024)