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Industrial Dosage Form Technologies
Study Course Description
Course Description Statuss:Approved
Course Description Version:7.00
Study Course Accepted:01.09.2022 09:11:38
Study Course Information | |||||||||
Course Code: | ZFTK_014 | LQF level: | Level 7 | ||||||
Credit Points: | 9.00 | ECTS: | 13.50 | ||||||
Branch of Science: | Basic Sciences of Medicine, including Pharmacy | Target Audience: | Pharmacy | ||||||
Study Course Supervisor | |||||||||
Course Supervisor: | Ilze Bārene | ||||||||
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) | 11 | Lecture Length (academic hours) | 3 | Total Contact Hours of Lectures | 33 | ||||
Classes (count) | Class Length (academic hours) | Total Contact Hours of Classes | 0 | ||||||
Total Contact Hours | 33 | ||||||||
Full-Time - Semester No.2 | |||||||||
Lectures (count) | 6 | Lecture Length (academic hours) | 2 | Total Contact Hours of Lectures | 12 | ||||
Classes (count) | 13 | Class Length (academic hours) | 4 | Total Contact Hours of Classes | 52 | ||||
Total Contact Hours | 64 | ||||||||
Full-Time - Semester No.3 | |||||||||
Lectures (count) | 0 | Lecture Length (academic hours) | 0 | Total Contact Hours of Lectures | 0 | ||||
Classes (count) | 8 | Class Length (academic hours) | 4 | Total Contact Hours of Classes | 32 | ||||
Total Contact Hours | 32 | ||||||||
Part-Time - Semester No.1 | |||||||||
Lectures (count) | 10 | Lecture Length (academic hours) | 4 | Total Contact Hours of Lectures | 40 | ||||
Classes (count) | 10 | Class Length (academic hours) | 4 | Total Contact Hours of Classes | 40 | ||||
Total Contact Hours | 80 | ||||||||
Part-Time - Semester No.2 | |||||||||
Lectures (count) | 6 | Lecture Length (academic hours) | 4 | Total Contact Hours of Lectures | 24 | ||||
Classes (count) | 6 | Class Length (academic hours) | 4 | Total Contact Hours of Classes | 24 | ||||
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, Pharmacology. 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. | ||||||||
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 | 1.00 | auditorium | |||||
2 | Basic rules for industrial production of medicinal products. Good Manufacturing Practice (GMP). | Lectures | 1.00 | auditorium | |||||
3 | European Pharmacopoeia. | Lectures | 1.00 | 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 | 1.00 | 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 | 1.00 | 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 | 1.00 | 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 | |||||
Topic Layout (Part-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 | laboratory | |||||
3 | European Pharmacopoeia. | Lectures | 0.50 | laboratory | |||||
4 | Pharmaceutical excipients characterisation. Characterisation of packing materials for dosage forms. | Lectures | 0.50 | 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 | 2.00 | 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 | 1.00 | 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 | 1.00 | 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 | 1.00 | 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 | 1.50 | 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 | 0.50 | auditorium | |||||
18 | Liquid pharmaceutical forms. Sterile dosage forms. | Classes | 4.50 | laboratory | |||||
19 | Alcoholimetry. | Classes | 1.00 | laboratory | |||||
20 | Herbal products. | Classes | 3.00 | laboratory | |||||
21 | Solid dosage forms. | Classes | 2.00 | laboratory | |||||
22 | Biopharmaceutics. | Classes | 1.00 | laboratory | |||||
23 | Capsules and medical pencils. | Classes | 2.00 | laboratory | |||||
24 | Semi-solid dosage forms. Rectal and vaginal dosage forms. | Classes | 2.50 | laboratory | |||||
Assessment | |||||||||
Unaided Work: | Individual work – drawing up protocols and calculating tasks according to the topics of the study course. | ||||||||
Assessment Criteria: | 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. | ||||||||
Final Examination (Full-Time): | Exam (Written) | ||||||||
Final Examination (Part-Time): | Exam (Written) | ||||||||
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. | ||||||||
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. | ||||||||
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 medicine. | ||||||||
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. 2013. 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. 2016. European pharmacopoeia. 9th 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. 2012. Handbook of pharmaceutical excipients / edited by Raymond C. Rowe [et al.]. 7th ed. London; Philadelphia: Pharmaceutical Press; Washington, DC: American Pharmaceutical Association. | ||||||||
Additional Reading | |||||||||
1 | Allen, L. V. 2008. Suppositories / Loyd V. Allen, Jr, with contributions by Dennis B. Worthen, and Bill Mink. 1st ed., 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. |