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Pharmaceutical Formulations

Study Course Description

Course Description Statuss:Approved
Course Description Version:4.00
Study Course Accepted:02.07.2024 11:56:02
Study Course Information
Course Code:ZFTK_051LQF level:Level 7
Credit Points:2.00ECTS:3.00
Branch of Science:Basic Sciences of Medicine, including Pharmacy; Technology of Drug FormsTarget Audience:Medicine
Study Course Supervisor
Course Supervisor:Oxana Brante
Study Course Implementer
Structural Unit:Department of Applied Pharmacy
The Head of Structural Unit:
Contacts:Riga, 16 Dzirciema Street, zftkatrsu[pnkts]lv, +371 67061547
Study Course Planning
Full-Time - Semester No.1
Lectures (count)2Lecture Length (academic hours)4Total Contact Hours of Lectures8
Classes (count)2Class Length (academic hours)4Total Contact Hours of Classes8
Total Contact Hours16
Full-Time - Semester No.2
Lectures (count)0Lecture Length (academic hours)Total Contact Hours of Lectures0
Classes (count)4Class Length (academic hours)4Total Contact Hours of Classes16
Total Contact Hours16
Study course description
Preliminary Knowledge:
Biochemistry, medical physics, medical microbiology, human anatomy and physiology.
Objective:
To promote the acquisition of knowledge and understanding of different pharmaceutical formulations and drug delivery systems, their relationship to the route of administration and therapeutic efficacy of drugs, as well as the basic principles of drug production.
Topic Layout (Full-Time)
No.TopicType of ImplementationNumberVenue
1Active pharmaceutical ingredients and excipients, their role in drug manufacturing and therapeutic efficacy of medicines.Lectures1.00auditorium
2Pharmaceutical technologies, basic processes of dosage form production.Lectures1.00auditorium
3Novel pharmaceutical formulations. Modified-release (prolonged-release) and paediatric dosage forms. Polymers. Stability of pharmaceutical formulations.Classes1.00laboratory
4Preclinical and clinical research. Trial phases and bioequivalence studies.Classes1.00laboratory
5Drug registration (marketing authorisation) requirements. Biopharmaceuticals and advanced therapy medicinal products. Biosimilars. Medical devices.Classes1.00laboratory
6Basic principles of pharmaceutical manufacturing and quality control. Regulations and guidelines (Ph.Eur. and GMP).Classes1.00laboratory
7Characteristics of pharmacokinetics depending on the dosage form. Pharmaceutical drug interactions and incompatibilitiesClasses1.00laboratory
8Test. Students presentations.Classes1.00laboratory
Assessment
Unaided Work:
Individual and group work – preparation of presentations according to the course topics, work with literature and databases.
Assessment Criteria:
1. Active participation in practical classes. 2. Presentations of individual and group work.
Final Examination (Full-Time):Exam (Written)
Final Examination (Part-Time):
Learning Outcomes
Knowledge:Upon successful completion of the study course, students will be able to characterise pharmaceutical formulations, their differences and advantages to achieve the desired therapeutic effect. Students will also understand the importance of pharmaceutical manufacturing and medicinal product quality compliance with the requirements of regulations and guidelines (Ph.Eur. and GMP).
Skills:Upon successful completion of the study course, students will be able to explain the pharmacokinetic and pharmacodynamic processes, as well as the differences between original medicines, generics and biopharmaceuticals. Students will be familiar with the parenteral and enteral dosage forms and basic principles of drug interactions.
Competencies:Successful completion of the study course will allow students to critically assess the relationship between the pharmaceutical formulation, the route of administration and therapeutic efficacy of drugs.
Bibliography
No.Reference
Required Reading
1Aulton, M. E. and Taylor, K. 2022. Aulton's pharmaceutics: The design and manufacture of medicines / edited by Michael E. Aulton and Kevin M.G. Taylor. 4th ed. Edinburgh, [etc.]: Churchill Livingstone/Elsevier.
2Jones, D. 2016. Pharmaceutics – dosage form and design / David Jones. Second ed. London: Pharmaceutical Press.
3Fox, S. C. 2014. Pharmaceutics / Shelley Chambers Fox. 1st ed. London: Pharmaceutical Press.
4Florence, A. T. 2016. Physicochemical principles of pharmacy: In manufacture, formulation and clinical use / Alexander T. Florence and David Attwood. 6th ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
5Rowe, R. C. 2020. Handbook of pharmaceutical excipients / edited by Raymond C. Rowe [et al.]. 9th ed. London; Philadelphia: Pharmaceutical Press; Washington, DC: American Pharmaceutical Association.
Additional Reading
1European Directorate for the Quality of Medicines and Healthcare. 2019-2021 European pharmacopoeia. 10th ed. Strasbourg: Council of Europe.
2EudraLex. 2010. The Rules Governing Medicinal products in the European Union. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use.
3Guidance issued by the European Medicines Agency (EMA). Available from: www.ema.europa.eu.