Finished Dosage Forms

Study Course Description

Course Description Statuss:Approved

Course Description Version:5.00

Study Course Accepted:23.08.2023 13:35:22

Study Course Information
Course Code:		ZFTK_033		LQF level:		Level 7
Credit Points:		8.00		ECTS:		12.00
Branch of Science:		Basic Sciences of Medicine, including Pharmacy; Technology of Drug Forms		Target Audience:		Pharmacy
Study Course Supervisor
Course Supervisor:		Marina Timošenko
Study Course Implementer
Structural Unit:		Department of Applied Pharmacy
The Head of Structural Unit:
Contacts:		Riga, Dzirciema street 16, zftkrsu[pnkts]lv, +371 67061547
Study Course Planning
Full-Time - Semester No.1
Lectures (count)		14	Lecture Length (academic hours)		4	Total Contact Hours of Lectures		56
Classes (count)		14	Class Length (academic hours)		4	Total Contact Hours of Classes		56
Total Contact Hours								112
Study course description
Preliminary Knowledge:
In inorganic and organic chemistry, quantitative analysis, plant and animal biology, mathematics and computer science, physics, physical pharmacy, medical biochemistry, environmental health, microbiology, medicinal chemistry, pharmaceutical chemistry, pharmacognosy with phytopharmacy course, pharmacology, English. Knowledge of human anatomy, normal physiology is desirable.
Objective:
To promote formation of understanding of the manufacturing process of finished dosage forms, its stages and the factors influencing the process.
Topic Layout (Full-Time)
No.	Topic			Type of Implementation		Number	Venue
1	Characterisation of dosage forms.			Lectures		1.00	auditorium
2	Characterisation of the physical, chemical, functional and toxicological properties of excipients.			Lectures		1.00	auditorium
3	Basic principles of the development of dosage forms according to EU guidelines (quality assessment of active substances according to guidelines on impurities, basic principle for selecting the most appropriate excipients, formulation development, technology development, choice of packaging materials).			Lectures		1.00	auditorium
4	Advanced theory of the granulation process			Lectures		1.00	auditorium
5	Wet granulation in High-shear mixer, drying in fluid bed equipment, reassembling equipment. Granulation quality testing.			Classes		2.00	laboratory
6	Regulatory and recording documentation of the manufacturing process of medicinal products.			Classes		1.00	laboratory
7	Basic principles for the development and introduction of a new finished dosage form into production (development of the technological scheme and production process description, scaling).			Lectures		1.00	auditorium
8	Development of analysis methods and validation thereof for quality assessment of finished dosage forms. Development of the final product specification.			Lectures		1.00	auditorium
9	Risk assessment in the field of manufacturing of finished medicinal products.			Lectures		2.00	auditorium
10	Product labour intensity calculations. Development of norms for the consumption of materials and raw materials. Planning and rational use of production equipment capacity, materials and personnel resources.			Lectures		1.00	auditorium
11	Advanced compression theory			Lectures		1.00	laboratory
12	Compression (tabletting), quality analysis of tablets			Classes		2.00	laboratory
13	Process planning for the manufacture and sale of finished dosage forms. Plans for the manufacture and transfer of finished medicinal products. A presentation on the plans for the manufacture and transfer of finished medicinal products; product labour intensity calculations.			Lectures		2.00	auditorium
				Classes		1.00	auditorium
14	Theory of coating process			Lectures		1.00	laboratory
15	Coating in pan coater and packaging			Classes		2.00	laboratory
16	Paediatric dosage forms. Basic principles of development of dosage forms for children.			Lectures		1.00	auditorium
17	Roller compactor; hot melting extrusion			Classes		2.00	auditorium
18	A class by a visiting professor.			Classes		4.00	laboratory
Assessment
Unaided Work:
Individual and group work – preparation of presentations, according to course topics, work with literature. In order to evaluate the quality of the study course as a whole, the student must fill out the study course evaluation questionnaire on the Student Portal.
Assessment Criteria:
- active participation in the practical classes (20%); - presentation of group work (30%); - an exam at the end of the course, consisting of a written part and a presentation (50%).
Final Examination (Full-Time):		Exam
Final Examination (Part-Time):
Learning Outcomes
Knowledge:		As a result of successful completion of the study course, students will be able to relate and describe the physicochemical, toxicological properties of active substances to their biological activity; know the origin of active pharmaceutical ingredients and key excipients and how they are purified, characterised and analysed; be able to explain the pharmacokinetic and pharmacodynamic process; understand the basic principles of formulation; be able to discuss the compatibility of the active pharmaceutical ingredient, excipients, packaging, quality and nomenclature of excipients used in the development of finished dosage forms, be able to describe their properties and specifics; be able to outline the advantages of a particular dosage form and the rationale for choosing it. Will know the quality requirements for manufacturing processes in both small and industrial scale production of pharmaceutical products – finished dosage forms; planning of manufacturing and sales processes of finished dosage forms, plans for manufacturing of medicinal products and transfer of the finished product.
Skills:		As a result of successfully completing the study course, students: - understand the process of developing finished dosage forms, - are able to formulate finished dosage forms taking into account the physicochemical and functional properties of the active substances and excipients and the pharmacological and toxicological properties of the active substance, - select the most appropriate excipients, technologies, packaging materials for the development of finished dosage forms, based on research results.
Competencies:		As a result of successful completion of the study course, students will be able to critically evaluate the interrelationship between the formulation, finished dosage form, route of administration and therapeutic efficacy of a medicinal product; be able to perform dosage form development and standardisation; be able to perform quality control of finished dosage forms.
Bibliography
No.	Reference
Required Reading
1	EudraLex. The Rules Governing Medicinal products in the European Union. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, 2010 (akceptējams izdevums)
2	LR MK noteikumi nr. 376. “Zāļu reģistrēšanas kārtība“
3	LR MK noteikumi Nr.304
4	European Directorate for the Quality of Medicines and Healthcare. 2019-2021. European pharmacopoeia. 10th ed. Strasbourg: Council of Europe.
5	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)
6	Fox, S. C. 2014. Pharmaceutics / Shelley Chambers Fox. 1st ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
7	Jones, D. 2016. Pharmaceutics - dosage form and design / David Jones. Second ed. London: Pharmaceutical Press.
8	Ārvalstu studentiem/For international students:
9	European Directorate for the Quality of Medicines and Healthcare. 2019-2021. European pharmacopoeia. 10th ed. Strasbourg: Council of Europe.
10	Fox, S. C. 2014. Pharmaceutics / Shelley Chambers Fox. 1st ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
11	Jones, D. 2016. Pharmaceutics - dosage form and design / David Jones. Second ed. London: Pharmaceutical Press.
Other Information Sources
1	Eiropas zāļu aģentūras (EMA) vadlīnijas