F1FO2_13 Dosage Forms and Biopharmacy II

Faculty of Pharmacy
Spring 2025
Extent and Intensity
3/6/0. 11 credit(s). Type of Completion: zk (examination).
In-person direct teaching
Teacher(s)
doc. PharmDr. Aleš Franc, Ph.D. (lecturer)
doc. PharmDr. Jan Gajdziok, Ph.D. (lecturer)
doc. PharmDr. Kateřina Kubová, Ph.D. (lecturer)
doc. PharmDr. Ruta Masteiková, CSc. (lecturer)
PharmDr. Jakub Vysloužil, Ph.D. (lecturer)
doc. PharmDr. Aleš Franc, Ph.D. (seminar tutor)
doc. PharmDr. Jan Gajdziok, Ph.D. (seminar tutor)
doc. PharmDr. Kateřina Kubová, Ph.D. (seminar tutor)
PharmDr. Miroslava Pavelková, Ph.D. (seminar tutor)
PharmDr. Jakub Vysloužil, Ph.D. (seminar tutor)
PharmDr. Hana Hořavová (seminar tutor)
PharmDr. Kateřina Brückner, Ph.D. (seminar tutor)
PharmDr. Jiří Zeman, Ph.D. (seminar tutor)
Mgr. Daniela Hlavatá (seminar tutor)
Mgr. Lucie Pizúrová (seminar tutor)
PharmDr. Lucie Sedláčková (seminar tutor)
Guaranteed by
doc. PharmDr. Kateřina Kubová, Ph.D.
Department of Pharmaceutical Technology – Departments – Faculty of Pharmacy
Supplier department: Department of Pharmaceutical Technology – Departments – Faculty of Pharmacy
Prerequisites
F1FO1_13 Dosage Forms and Biopharmacy
F1FO1_13 Dosage forms and biofarmacie I - credits
Course Enrolment Limitations
The course is also offered to the students of the fields other than those the course is directly associated with.
The capacity limit for the course is 165 student(s).
Current registration and enrolment status: enrolled: 0/165, only registered: 0/165, only registered with preference (fields directly associated with the programme): 0/165
fields of study / plans the course is directly associated with
Course objectives
One of the main obligatory pharmaceutical disciplines dealing with preparation, manufacturing and quality control of medicaments including technological procedures, equiment, excipients and appropriate analytical devices. It covers the influence of the application form on drug bioavailability.
Learning outcomes
Upon completion of the course, the student will:
-describe the classification, requirements, excipients, and technological procedures for the preparation and production of solid dosage forms including their evaluation;
-theoretically describe the classification, requirements, excipients, and technological procedures of preparation and production of controlled release dosage forms including their evaluation;
- identify the function of excipients in medicinal products;
- identify the basic aspects of solid dosage forms relating to drug bioavailability;
- prepare practically semi-solid and solid dosage forms under pharmacy conditions;
- detect basic incompatibilities when preparing a medicinal product according to a prescription;
- explain the basic principles of GMP
Syllabus
  • SYLLABUS OF LECTURES
    1. Rectal dosage forms - definition, classification, properties. Suppositories, excipients, preparation, quality evaluation.
    2. Vaginal dosage forms - definition, classification, properties, excipients, quality evaluation.
    3. Granules, basic granulation techniques and equipment. Quality evaluation of powders and granules.
    4. Incompatibilities in semisolid and solid dosage forms.
    5. Tablets - classification, basic compression techniques. Excipients for tablets. Quality evaluation and use.
    6. Coated products - classification, basic coating techniques, quality evaluation and use.
    7. Drug microforms. Definition, classification, characteristics, production technology, quality assessment
    8. Transdermal preparations. Basic types of transdermal therapeutic systems. Excipients for transdermal preparations. Quality evaluation and use.
    9. Aerodispersions - definition, classification, properties. Basic types of inhalation systems. Excipients for aerodispersions. Quality evaluation and use.
    10. Capsules - classification, production, excipients, quality evaluation and use.
    11. Public holiday.
    12. Public holiday.
    13. Controlled-release oral dosage forms
    14.The principles of good manufacturing practice.

    PRACTICAL TRAINING
    1. Ointments. Preparation and evaluation.
    2. Creams. Preparation and evaluation.
    3. Pastes and gels. Preparation and evaluation.
    4. Rectal suppositories. Determination of calibration coefficient. Semisolid dosage forms - test.
    5. Rectal suppositories. Preparation of suppositories with known and unknown base replacement coefficient. Evaluation.
    6. Preparation of vaginal globules by Starkes method, preparation of lipophilic vaginal globules. Evaluation. Suppositories ans vaginal globules - test.
    7. Technological procedures in preparation of complicated prescriptions of semisolid dosage forms, powders and suppositories.
    8. Solving of incompatibilities in prescriptions on semisolid and solid dosage forms, powders and suppositories, preparations according to prescriptions.
    9. Alternative training.
    10. Production of tablets by direct compression/Granulation techniques.
    11. Granulation techniques/Production of tablets by direct compression.
    12. Fluid bed granulation technique/Evaluation of solid dosage forms.
    13. Evaluation of solid dosage forms/Fluid bed granulation technique.
    14. Test. Prastical skills testing.
Literature
    required literature
  • Komárek, P., Rabišková, M. Technologie léků. Galén, Praha, 2006. ISBN 80-7262-423-7. info
    recommended literature
  • Aqueous polymeric coatings for pharmaceutical dosage forms. Edited by Linda A. Felton. Fourth edition. Boca Raton, FL: CRC Press, 2017, 1 online. ISBN 9781315369938. URL info
  • Ministerstvo zdravotnictví. Český lékopis 2017. 2017. info
  • RABIŠKOVÁ, Miloslava. Moderní lékové formy pro orální a peroální aplikaci. Bratislava: Univerzita Komenského, 2009, 175 s. ISBN 9788022327596. info
    not specified
  • Zathurecký, L., Chalabala, M., Janků, I., Modr., Z. Biofarmácia a farmakokinetika. Osveta Martin, 1989. ISBN 80-217-0068-8. info
  • Chalabala, M., Heinrich, J. Základy výroby a tvorby liekov. Osveta Martin, 1988. info
Teaching methods
1.Lectures - frontal teaching in the form of a powerpoint presentation
2.Lab training - preparation according to prescriptions, preparation of reports, individual discussion over the prepared product
3.Homework
Assessment methods
1.Written credit test: part 1 (min. 60 %) - open and closed questions in the range of knowledge from practical part and lectures F1F02-13 (including lectures focusing semi-solid dosage forms), part 2 (min. 75 %) - pharmaceutical calculations
2.Intermediate tests: total 2 (min. 60 % - max. two repetitions)
3.Systematic observation of students during lab training
4.Practical test of student skills (1 products)
5.Oral examination - a prerequisite for participation in the exam is to meet credit in the course F1FO1-13 and the conditions for participation in the examination in the course F1F02-13.
Language of instruction
Czech
Further comments (probably available only in Czech)
Study Materials
The course can also be completed outside the examination period.
Teacher's information
Lectures are recommended due to the lack of suitable literature.
Practical labs are mandatory.
The course is also listed under the following terms Spring 2020, Spring 2021, Spring 2022, Spring 2023, Spring 2024.
  • Enrolment Statistics (Spring 2025, recent)
  • Permalink: https://is.muni.cz/course/pharm/spring2025/F1FO2_13