F1FO1_13 Dosage Forms and Biopharmacy I

Faculty of Pharmacy
Autumn 2024
Extent and Intensity
3/6/0. 5 credit(s). Type of Completion: z (credit).
In-person direct teaching
Teacher(s)
doc. PharmDr. Aleš Franc, Ph.D. (lecturer)
doc. PharmDr. Kateřina Kubová, Ph.D. (lecturer)
doc. PharmDr. Ruta Masteiková, CSc. (lecturer)
PharmDr. Kateřina Brückner, Ph.D. (seminar tutor)
doc. PharmDr. Jan Gajdziok, Ph.D. (lecturer)
PharmDr. Miroslava Pavelková, Ph.D. (lecturer)
PharmDr. Jakub Vysloužil, Ph.D. (lecturer)
Mgr. Daniela Hlavatá (seminar tutor)
PharmDr. Hana Hořavová (seminar tutor)
Mgr. Lucie Pizúrová (seminar tutor)
PharmDr. Lucie Sedláčková (seminar tutor)
Mgr. Martin Veselý (seminar tutor)
PharmDr. Jiří Zeman, Ph.D. (seminar tutor)
Guaranteed by
doc. PharmDr. Kateřina Kubová, Ph.D.
Department of Pharmaceutical Technology – Departments – Faculty of Pharmacy
Contact Person: doc. PharmDr. Kateřina Kubová, Ph.D.
Supplier department: Department of Pharmaceutical Technology – Departments – Faculty of Pharmacy
Timetable
Thu 12:50–15:20 44-056, except Thu 10. 10. ; and Thu 10. 10. 12:50–15:20 44-037
  • Timetable of Seminar Groups:
F1FO1_13/01: Mon 7:30–9:10 18-122, Mon 9:10–12:30 18-138, K. Kubová
F1FO1_13/02: Mon 7:30–12:30 18-107, M. Pavelková, L. Sedláčková
F1FO1_13/03: Tue 7:30–9:10 18-122, Tue 9:10–12:30 18-138, H. Hořavová
F1FO1_13/04: Tue 7:30–12:30 18-107, L. Pizúrová
F1FO1_13/05: Tue 13:00–14:40 18-122, Tue 14:40–18:00 18-138, A. Franc
F1FO1_13/06: Tue 13:00–18:00 18-107, M. Veselý
F1FO1_13/07: Wed 7:30–9:10 18-122, Wed 9:10–12:30 18-138, K. Brückner
F1FO1_13/08: Wed 7:30–12:30 18-107, J. Zeman
F1FO1_13/09: Wed 13:00–14:40 18-122, Wed 14:40–18:00 18-138, J. Gajdziok, D. Hlavatá
F1FO1_13/10: Wed 13:00–18:00 18-107, J. Vysloužil
Prerequisites (in Czech)
FAKULTA(FaF) || OBOR(MUSFaF)
Course Enrolment Limitations
The course is only offered to the students of the study fields the course is directly associated with.

The capacity limit for the course is 160 student(s).
Current registration and enrolment status: enrolled: 117/160, only registered: 0/160
fields of study / plans the course is directly associated with
Course objectives
Pharmaceutical technology is a fundamental discipline within the pharmaceutical field. The course aims to introduce students to compounding, industrial production, and quality control of medications, including excipients, technological procedures, equipment, and appropriate analytical devices. Additionally, it covers the impact of the drug's application form on its bioavailability within the organism.
Learning outcomes
Upon successful completion of the course, students will be able to:
- theoretically know the classification, requirements, excipients, technological procedure of preparation and production of liquid dosage forms and their evaluation (solutions, emulsions, suspensions)
- theoretically know the classification, requirements, excipients, and technological procedure for the preparation and manufacture of ophthalmic, nasal, and ear preparations and their evaluation
- theoretically know the classification, requirements, excipients, and technological procedure for the preparation and manufacture of parenteral preparations and their evaluation
- theoretically know the classification, requirements, excipients, and technological procedure for the preparation and manufacture of semi-solid dosage forms and their evaluation (ointments, pastes, creams, gels)
- to determine the basic aspects of dosage forms in relation to the bioavailability of the drug
- to perform essential calculations (concentrations, doses, mixing equations, ratios, etc.)
- to check the doses of a drug in a medicinal product according to the prescription of the product according to Pharmacopoeia
- to prepare both pharmacopoeial and non-pharmacopoeial solutions, syrups, aromatic waters, suspensions, emulsions, eye drops, nasal drops, and ear drops skillfully
- to detect fundamental incompatibilities in the composition of individually formulated medicinal products
- to determine the shelf life of individually formulated medicinal products
- to select suitable packaging options for individually formulated medicinal products
- to estimate the optimal storage conditions required for individually formulated medicinal products
Syllabus
  • SYLLABUS OF LECTURES
    1. Introduction into Medical Forms and Biopharmacy. Solutions: basic methods of preparation, quality evaluation.
    2. Sterilization techniques. Requirements for the preparation of sterile medications.br>3. Ophthalmic preparations - definition, classification, preparation, quality evaluation, the bioavailability of drugs from ophthalmic products.
    4. On-line!!!Nasal and ear preparations: definition, classification, characteristics, technological aspects.
    5. Excipients for preparation of liquid dosage forms (solutions). Water for pharmaceutical purposes.
    6. Pharmaceutical emulsions - definition, classification, preparation, quality evaluation. Physical aspects of emulsions.
    7.Pharmaceutical suspensions - definition, classification, preparation, quality evaluation.
    8. Incompatibilities in liquid dosage forms.
    9. Herbal drug preparations - definition, classification, preparation and production, quality assessment.
    10. Powders, classification, particle size and effect on drug bioavailability; preparation, use and quality evaluation.
    11. Parenteral preparations: definition, classification, requirements, excipients, preparation and manufacture, quality assessment.
    12. Topical semisolid preparations: definition, classification, properties, excipients.
    13. Topical semisolid preparations: preparation and quality evaluation.

    PRACTICAL TRAINING
    1. Introduction to the practical training. Pharmaceutical calculations.
    2. Medicinal solutions: preparation at room and higher temperature, evaluation.
    3. Medicinal solutions: preparation by solubilization and chemical reaction, evaluation. Test - Pharmaceutical calculations.
    4. Aromatic waters and spirits. Syrups. Infusions and decoctions. Mucilagines. Preparation and evaluation.
    5. Eye drops. Preparation and evaluation.
    6. Nasal and ear drops. Preparation and evaluation.
    7. Consultation exercise on liquid dosage forms.
    8.Emulsions. Preparation and evaluation. Test - calculations for eye and nasal medicinal products.
    9. Suspensions. Preparation and evaluation. Test - emulsifiers.
    10. Preparation of liquid dosage forms according to prescriptions.
    11. Divided and non-divided powders. Preparation and evaluation.
    12. Alternative training.
    13. Credit test and testing of laboratory skills.
Literature
    required literature
  • Český lékopis - platné vydání a doplňky. info
  • Komárek, P., Rabišková, M. Technologie léků. Galén, Praha, 2006. ISBN 80-7262-423-7. info
    recommended literature
  • Dosage forms, formulation developments, and regulations : recent and future trends in pharmaceutics. Edited by Amit Kumar Nayak - Kalyan Kumar Sen. London: Academic Press, an imprint of Elsevier, 2024, 1 online. ISBN 9780323972468. URL info
  • TEIXEIRA, Maria Glaucia and Joel L. ZATZ. Pharmaceutical calculations. Fifth edition. Hoboken, New Jersey: Wiley, 2017, 1 online. ISBN 9781118978535. URL info
    not specified
  • Časopis Česká a slovenská farmacie. info
Teaching methods
Lectures
Lab training - preparation of dosage forms, discussion of the technological process and use of the product
Home study as preparation for practical classes
Assessment methods
Intermediate tests in laboratory classes (3 tests, two retakes are possible)
Systematic observation of the student during laboratory classes, preparation of reports following the teacher's instructions
Credit test (credit test has two parts, part 1 - pharmaceutical calculations (limit for passing 75%), part 2 - test - closed and open questions (especially opened) from knowledge from lectures and laboratory classes (limit for passing - 60%).
Practical testing is conducted to evaluate students' skills as part of the credit assessment. (preparation of the medicinal product - detection of incompatibilities, control of dosage, selection of the correct procedure, selection of appropriate packaging, correct labeling of the product - shelf life, storage conditions).
Language of instruction
Czech
Follow-Up Courses
Further comments (probably available only in Czech)
Study Materials
The course can also be completed outside the examination period.
Listed among pre-requisites of other courses
Teacher's information
Lectures are recommended due to a lack of suitable literature.
Laboratory classes are obligatory (100 %).
Credit for courses will only be awarded where a student will:
- participate in 100% of a lab part of the course (maximum in two cases, individual laboratory classes can be done later - alternative class according to syllabus)
- complete successfully three tests during semester
- to successfully complete a credit test at the end of the course
- complete successfully testing of laboratory skill at the end of the course.
The course is also listed under the following terms Autumn 2020, Autumn 2021, Autumn 2022, Autumn 2023.
  • Enrolment Statistics (recent)
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