Industrial Dosage Form Technologies and Placement

Study Course Description

Course Description Statuss:Approved

Course Description Version:3.00

Study Course Accepted:22.08.2023 08:54:50

Study Course Information
Course Code:		ZFTK_059		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, 16 Dzirciema Street, zftkrsu[pnkts]lv, +371 67061547
Study Course Planning
Full-Time - Semester No.1
Lectures (count)		14	Lecture Length (academic hours)		2	Total Contact Hours of Lectures		28
Classes (count)		9	Class Length (academic hours)		4	Total Contact Hours of Classes		36
Total Contact Hours								64
Full-Time - Semester No.2
Lectures (count)		0	Lecture Length (academic hours)		0	Total Contact Hours of Lectures		0
Classes (count)		12	Class Length (academic hours)		4	Total Contact Hours of Classes		48
Total Contact Hours								48
Study course description
Preliminary Knowledge:
Inorganic, Organic, Pharmaceutical Chemistry, Quantitative Analysis, Plant and Animal Biology, Mathematics, Informatics, Physics, Physical Pharmacy, Medical Biochemistry, Environmental health, Microbiology, Medical chemistry, Pharmaceutical chemistry Pharmacognosy, Pharmaceutical Pharmacology, Pharmacotherapy. Desirable knowledge in Human Anatomy, Normal Physiology, English.
Objective:
1. Encourage acquisition of knowledge and formation of understanding about theoretical bases and practical methods of development, manufacturing, quality evaluation of dosage forms. 2. Encourage acquisition of practical skills in preparation and quality evaluation of dosage forms. 3. To gain insight into the requirements of good manufacturing practice, environmental and occupational safety requirements, and the production of finished dosage forms in a pharmaceutical company or RSU Final dosage form laboratory
Topic Layout (Full-Time)
No.	Topic			Type of Implementation		Number	Venue
1	Dosage forms' classification and characterisation. Guidelines on dosage forms' development. Classification and characterisation of the main processes of pharmaceutical technology.			Lectures		0.50	auditorium
2	Basic rules for industrial production of medicinal products. Good Manufacturing Practice (GMP).			Lectures		0.50	auditorium
3	European Pharmacopoeia.			Lectures		0.50	auditorium
4	Pharmaceutical excipients characterisation. Characterisation of packing materials for dosage forms.			Lectures		1.00	auditorium
5	Stabilising pharmaceutical forms. Study stability and timing of active substances and dosage forms. Packaging of medicinal products. Labelling of dosage forms.			Lectures		1.00	auditorium
6	The nature and importance of biopharmacy in dosage form technology. Description of methods for evaluating the biological usefulness of dosage forms.			Lectures		1.00	auditorium
7	Food and drug interaction. Exposure of food products to excretion of active substances from the formulation, absorption, biotransport and elimination.			Lectures		1.00	auditorium
8	Dispersible systems. Preparation and quality testing of emulsions and suspensions. Aerosols. Propellents characterisation. Aerosol technology and quality testing.			Lectures		1.00	auditorium
9	Preparations of animal organs and tissues. Classification. Characteristics, standardisation and storage of raw materials. Pharmaceutical forms. Hormone preparations. Technology and standardisation. Enzyme preparations, their extraction, standardisation. Tissue preparations, forms of their medicinal products. Biological fluids. Blood preparations. Insight into getting biological medicines. Classification of biological medicinal products.			Lectures		1.00	auditorium
10	Extraction preparations. Herbals as porous materials for extraction. Factors affecting the extraction process. Assortment and characterisation of solvents. Methods of extraction. Apparatus and devices to be used for extraction. Herbal teas. Preparations of fresh plant material.			Lectures		0.50	auditorium
11	Classification of tinctures. The technological process of tincture and methods of extraction. Classification of extracts. Technological process of liquid extracts, thick and dry extracts. Hardware. Maximum purified phytopreparations. Characterisation of the extractive and purification process. Removal of individual active substances from plant material.			Lectures		1.00	auditorium
12	Parenteral dosage forms. Quality indicators of parenterals.			Lectures		0.50	auditorium
13	Technological process of manufacturing parenteral medicinal products. Preparation of containers for parenteral medicinal products. Preparation, stabilising, purification of injection solutions. Preparation of suspensions, emulsions, liophile dried powders. Process of filling the solution.			Lectures		0.50	auditorium
14	Description of the sterilization methods. Machines for sterilizing air, fluids and dry substances. Sterility test. Pyrogenic substances and bacterial endotoxins. Ophthalmic dosage forms.			Lectures		1.00	auditorium
15	Solid pharmaceutical forms. Powders, granules and their preparation technology. Quality control. Tablets. Classification of tablets, measurement of tablet quality. Theoretical justification of tablets preparation. Excipients for the preparation of tablets.			Lectures		1.00	auditorium
16	The technological process of tablets manufacturing. Tablet presses, their description. Packing of tablets. Characteristics and preparation technology of moulded tablets.			Lectures		1.00	auditorium
17	Coated tablets. Description of excipients to be used for couting. Tablets coating technology. The technology for making dragee and pellets.			Lectures		1.00	auditorium
18	Liquid pharmaceutical forms. Sterile dosage forms.			Classes		3.00	laboratory
19	Alcoholimetry.			Classes		1.00	laboratory
20	Herbal products.			Classes		3.00	laboratory
21	Solid dosage forms.			Classes		6.00	laboratory
22	Biopharmaceutics.			Classes		1.00	laboratory
23	Capsules and medical pencils.			Classes		3.00	laboratory
24	Semi-solid dosage forms. Rectal and vaginal dosage forms.			Classes		4.00	laboratory
Assessment
Unaided Work:
Individual work – drawing up protocols and calculating tasks according to the topics of the study course. Participation in excursions. 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:
Test: - written questions, tests, independent work – drawing up protocols and addressing tasks during practice sessions; - successfully passed tests on Good Manufacturing Practice and Occupational Safety in pharmaceutical company; - final test – multi-choice answer questions at the end of the last semester.
Final Examination (Full-Time):		Exam (Written)
Final Examination (Part-Time):
Learning Outcomes
Knowledge:		On successful completion of the course, students will be able to: 1. Understand the meaning of the dosage forms' development process. 2. Understand the meaning of the theoretical basic principles in the manufacturing of dosage forms. 3. Characterise the demands of dosage forms' quality corresponding to the normative documents. 4. Knowledge of good manufacturing practice and environmental and occupational safety requirements in a pharmaceutical company
Skills:		On successful completion of the course, students will be able to: 1. Apply knowledge about functionality-related charecteristics of excipients in the development of dosage forms. 2. Use technological techniques for preparing formulations of medicinal products. 3. Calculate the quantities of raw materials for the formulation of dosage form.. 4. Create a production process scheme and describe the process by stages. 5. Perform a quality assessment of the formulations of medicinal products in accordance with the requirements of the European Pharmacopoeia. 6. Present the results of your practical work correctly. 7. Will be able to comply with occupational safety requirements in the pharmaceutical company.
Competencies:		On successful completion of the course, students will be able to understand the meaning and usage of the theoretical basic principles of technology in the manufacturing of medicines. After placement will be able to supplement the theoretical knowledge acquired in the study course about equipment, technological processes with their practical application in manufacturing.
Clinical Skills:
No.	Skill					Level
1	Determination of disintegration of uncoated tablets					A - Beginner level
2	Determination of disintegration of uncoated tablets					B1 - Basic level
3	Determination of friability of tablets					A - Beginner level
4	Determination of friability of tablets					B1 - Basic level
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	European Directorate for the Quality of Medicines and Healthcare. 2019-2021. European pharmacopoeia. 10th ed. Strasbourg: Council of Europe.
3	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).
4	Fox, S. C. 2014. Pharmaceutics / Shelley Chambers Fox. 1st ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
5	Jones, D. 2016. Pharmaceutics - dosage form and design / David Jones. Second ed. London: Pharmaceutical Press.
6	Rowe, R. C. 2020. Handbook of pharmaceutical excipients / edited by Raymond C. Rowe [et al.] London; Philadelphia: Pharmaceutical Press; Washington, DC: American Pharmaceutical Association.
7	Prakses programma
Additional Reading
1	Allen, L. V. 2020. Suppositories / Loyd V. Allen, Jr, with contributions by Dennis B. Worthen, and Bill Mink. London; Chicago: Pharmaceutical Press.
2	Gibson, M. 2009. Pharmaceutical preformulation and formulation: A practical guide from candidate drug selection to commercial dosage form / edited by Mark Gibson. 2nd ed. Boca Ration: CRC Press, Taylor and Francis Group.
3	Labarre, D. J. P. 2011. Biomedical and pharmaceutical polymers / Denis J.-P. Labarre, Gilles Ponchel, Christine Vauthier. 1st ed. London; Chicago: Pharmaceutical Press.
4	Sandle, T. 2013. Sterility, sterilisation and sterility assurance for pharmaceuticals: Technology, validation and current regulations / Tim Sandle. 1st ed. Philadelphia, PA: Woodhead Publishing.