Veidlapa Nr. M-3 (8)
Study Course Description
Industrial Dosage Form Technologies
Course Code
ZFTK_053
Branch of Science
-
ECTS
12.00
Target Audience
Pharmacy
LQF
Level 7
Study Type And Form
Full-Time; Part-Time
Study Course Implementer
Course Supervisor
Ilze Bārene
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
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.
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. Desirable knowledge in Human Anatomy, Normal Physiology, English.
Learning Outcomes
Knowledge
1.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.
Skills
1.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.
Competences
1.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 medicine.
Assessment
Individual work
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Individual work |
-
|
-
|
|
Individual work – drawing up protocols and calculating tasks according to the topics of the study course.
|
||
Examination
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Examination |
-
|
-
|
|
Test:
• written questions, tests, independent work – drawing up protocols and addressing tasks during practice sessions;
• final test – multi-choice answer questions at the end of the last semester make a final assessment of the course.
|
||
Study Course Theme Plan
FULL-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Parenteral dosage forms. Quality indicators of parenterals.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
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.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Description of the sterilization methods. Machines for sterilizing air, fluids and dry substances. Sterility test. Pyrogenic substances and bacterial endotoxins. Ophthalmic dosage forms.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
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.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
The technological process of tablets manufacturing. Tablet presses, their description. Packing of tablets. Characteristics and preparation technology of moulded tablets.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Coated tablets. Description of excipients to be used for couting. Tablets coating technology. The technology for making dragee and pellets.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Liquid pharmaceutical forms. Sterile dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Liquid pharmaceutical forms. Sterile dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Liquid pharmaceutical forms. Sterile dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Alcoholimetry.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Herbal products.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Herbal products.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Herbal products.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Solid dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Solid dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Solid dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Solid dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Solid dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
0
|
Topics
|
Solid dosage forms.
|
Total ECTS (Creditpoints):
3.00
Contact hours:
33 Academic Hours
Final Examination:
Test (Semester)
Part 2
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Dosage forms' classification and characterisation. Guidelines on dosage forms' development. Classification and characterisation of the main processes of pharmaceutical technology.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Basic rules for industrial production of medicinal products. Good Manufacturing Practice (GMP).
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
European Pharmacopoeia.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Pharmaceutical excipients characterisation. Characterisation of packing materials for dosage forms.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Stabilising pharmaceutical forms. Study stability and timing of active substances and dosage forms. Packaging of medicinal products. Labelling of dosage forms.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
The nature and importance of biopharmacy in dosage form technology. Description of methods for evaluating the biological usefulness of dosage forms.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Food and drug interaction. Exposure of food products to excretion of active substances from the formulation, absorption, biotransport and elimination.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Dispersible systems. Preparation and quality testing of emulsions and suspensions.
Aerosols. Propellents characterisation. Aerosol technology and quality testing.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
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.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
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.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
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.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Biopharmaceutics.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Capsules and medical pencils.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Capsules and medical pencils.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Capsules and medical pencils.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Semi-solid dosage forms. Rectal and vaginal dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Semi-solid dosage forms. Rectal and vaginal dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Semi-solid dosage forms. Rectal and vaginal dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Semi-solid dosage forms. Rectal and vaginal dosage forms.
|
Total ECTS (Creditpoints):
6.00
Contact hours:
64 Academic Hours
Final Examination:
Test (Semester)
Part 3
Total ECTS (Creditpoints):
3.00
Contact hours:
32 Academic Hours
Final Examination:
Exam (Written)
PART-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
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.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
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.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
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.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
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.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
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.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
The technological process of tablets manufacturing. Tablet presses, their description. Packing of tablets. Characteristics and preparation technology of moulded tablets.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Alcoholimetry.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Herbal products.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Herbal products.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Herbal products.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Solid dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Solid dosage forms.
|
Total ECTS (Creditpoints):
7.50
Contact hours:
80 Academic Hours
Final Examination:
Test (Semester)
Part 2
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
Stabilising pharmaceutical forms. Study stability and timing of active substances and dosage forms. Packaging of medicinal products. Labelling of dosage forms.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
The nature and importance of biopharmacy in dosage form technology. Description of methods for evaluating the biological usefulness of dosage forms.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
Food and drug interaction. Exposure of food products to excretion of active substances from the formulation, absorption, biotransport and elimination.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
Dispersible systems. Preparation and quality testing of emulsions and suspensions.
Aerosols. Propellents characterisation. Aerosol technology and quality testing.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
Parenteral dosage forms. Quality indicators of parenterals.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
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.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
4
|
Topics
|
Description of the sterilization methods. Machines for sterilizing air, fluids and dry substances. Sterility test. Pyrogenic substances and bacterial endotoxins. Ophthalmic dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Liquid pharmaceutical forms. Sterile dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Liquid pharmaceutical forms. Sterile dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Liquid pharmaceutical forms. Sterile dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Liquid pharmaceutical forms. Sterile dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Biopharmaceutics.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Capsules and medical pencils.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Capsules and medical pencils.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Semi-solid dosage forms. Rectal and vaginal dosage forms.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
4
|
Topics
|
Semi-solid dosage forms. Rectal and vaginal dosage forms.
|
Total ECTS (Creditpoints):
4.50
Contact hours:
48 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.
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.
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.