.
Pharmaceutical Formulations
Study Course Description
Course Description Statuss:Approved
Course Description Version:3.00
Study Course Accepted:11.01.2022 15:01:47
| Study Course Information | |||||||||
| Course Code: | ZFTK_051 | LQF level: | Level 7 | ||||||
| Credit Points: | 2.00 | ECTS: | 3.00 | ||||||
| Branch of Science: | Basic Sciences of Medicine, including Pharmacy; Technology of Drug Forms | Target 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, zftk rsu[pnkts]lv, +371 67061547 | ||||||||
| Study Course Planning | |||||||||
| Full-Time - Semester No.1 | |||||||||
| Lectures (count) | 2 | Lecture Length (academic hours) | 4 | Total Contact Hours of Lectures | 8 | ||||
| Classes (count) | 2 | Class Length (academic hours) | 4 | Total Contact Hours of Classes | 8 | ||||
| Total Contact Hours | 16 | ||||||||
| Full-Time - Semester No.2 | |||||||||
| Lectures (count) | 0 | Lecture Length (academic hours) | Total Contact Hours of Lectures | 0 | |||||
| Classes (count) | 4 | Class Length (academic hours) | 4 | Total Contact Hours of Classes | 16 | ||||
| Total Contact Hours | 16 | ||||||||
| 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. | Topic | Type of Implementation | Number | Venue | |||||
| 1 | Active pharmaceutical ingredients and excipients, their role in drug manufacturing and therapeutic efficacy of medicines. | Lectures | 1.00 | auditorium | |||||
| 2 | Pharmaceutical technologies, basic processes of dosage form production. | Lectures | 1.00 | auditorium | |||||
| 3 | Novel pharmaceutical formulations. Modified-release (prolonged-release) and paediatric dosage forms. Polymers. Stability of pharmaceutical formulations. | Classes | 1.00 | laboratory | |||||
| 4 | Preclinical and clinical research. Trial phases and bioequivalence studies. | Classes | 1.00 | laboratory | |||||
| 5 | Drug registration (marketing authorisation) requirements. Biopharmaceuticals and advanced therapy medicinal products. Biosimilars. Medical devices. | Classes | 1.00 | laboratory | |||||
| 6 | Basic principles of pharmaceutical manufacturing and quality control. Regulations and guidelines (Ph.Eur. and GMP). | Classes | 1.00 | laboratory | |||||
| 7 | Characteristics of pharmacokinetics depending on the dosage form. Pharmaceutical drug interactions and incompatibilities | Classes | 1.00 | laboratory | |||||
| 8 | Presentation of prepared tasks. | Classes | 1.00 | laboratory | |||||
| 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 | |||||||||
| 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. | ||||||||
