Veidlapa Nr. M-3 (8)
Study Course Description
Pharmaceutical Formulations
Course Code
LFK_024
Branch of Science
Basic medicine; Technology of Drug Forms
ECTS
3.00
Target Audience
Medicine
LQF
Level 7
Study Type And Form
Full-Time
Study Course Implementer
Course Supervisor
Oxana Brante
Structure Unit Manager
Baiba Mauriņa
Structural Unit
Department of Applied Pharmacy
Contacts
Riga, 16 Dzirciema Street, zftk@rsu.lv, +371 67061547
About Study Course
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.
Preliminary Knowledge
Biochemistry, medical physics, medical microbiology, human anatomy and physiology.
Learning Outcomes
Knowledge
1.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
1.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.
Competences
1.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.
Assessment
Individual work
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Individual work |
-
|
-
|
|
Individual and group work – preparation of presentations according to the course topics, work with literature and databases.
|
||
Examination
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Examination |
-
|
-
|
|
1. Active participation in practical classes.
2. Presentations of individual and group work.
|
||
Study Course Theme Plan
FULL-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
Active pharmaceutical ingredients and excipients, their role in drug manufacturing and therapeutic efficacy of medicines.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
Pharmaceutical technologies, basic processes of dosage form production.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Novel pharmaceutical formulations. Modified-release (prolonged-release) and paediatric dosage forms. Polymers. Stability of pharmaceutical formulations.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Preclinical and clinical research. Trial phases and bioequivalence studies.
|
Total ECTS (Creditpoints):
1.50
Contact hours:
16 Academic Hours
Final Examination:
Test (Semester)
Part 2
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Drug registration (marketing authorisation) requirements. Biopharmaceuticals and advanced therapy medicinal products. Biosimilars. Medical devices.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Basic principles of pharmaceutical manufacturing and quality control. Regulations and guidelines (Ph.Eur. and GMP).
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Characteristics of pharmacokinetics depending on the dosage form. Pharmaceutical drug interactions and incompatibilities
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Test. Students presentations.
|
Total ECTS (Creditpoints):
1.50
Contact hours:
16 Academic Hours
Final Examination:
Exam (Written)
Bibliography
Required Reading
1.
Aulton, 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.
2.
Jones, D. 2016. Pharmaceutics – dosage form and design / David Jones. Second ed. London: Pharmaceutical Press.
3.
Fox, S. C. 2014. Pharmaceutics / Shelley Chambers Fox. 1st ed. London: Pharmaceutical Press.
4.
Florence, 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).
5.
Rowe, 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
1.
European Directorate for the Quality of Medicines and Healthcare. 2019-2021 European pharmacopoeia. 10th ed. Strasbourg: Council of Europe.
2.
EudraLex. 2010. The Rules Governing Medicinal products in the European Union. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use.
3.
Guidance issued by the European Medicines Agency (EMA). Available from: www.ema.europa.eu.