FAFO1_13 Dosage Forms and Biopharmacy I

Farmaceutická fakulta
podzim 2024
Rozsah
3/6/0. 5 kr. Ukončení: z.
Vyučováno kontaktně
Vyučující
doc. PharmDr. Aleš Franc, Ph.D. (přednášející)
doc. PharmDr. Jan Gajdziok, Ph.D. (přednášející)
doc. PharmDr. Kateřina Kubová, Ph.D. (přednášející)
PharmDr. Jakub Vysloužil, Ph.D. (přednášející)
doc. PharmDr. Aleš Franc, Ph.D. (cvičící)
doc. PharmDr. Jan Gajdziok, Ph.D. (cvičící)
doc. PharmDr. Kateřina Kubová, Ph.D. (cvičící)
PharmDr. Jakub Vysloužil, Ph.D. (cvičící)
PharmDr. Kateřina Brückner, Ph.D. (cvičící)
PharmDr. Hana Hořavová (cvičící)
PharmDr. Miroslava Pavelková, Ph.D. (cvičící)
PharmDr. Jiří Zeman, Ph.D. (cvičící)
Garance
doc. PharmDr. Kateřina Kubová, Ph.D.
Ústav farmaceutické technologie – Ústavy – Farmaceutická fakulta
Rozvrh
Čt 9:55–12:25 18-122
  • Rozvrh seminárních/paralelních skupin:
FAFO1_13/01: Čt 13:00–18:00 18-107, K. Brückner, A. Franc, J. Gajdziok, H. Hořavová, K. Kubová, M. Pavelková, J. Vysloužil, J. Zeman
FAFO1_13/02: Čt 13:00–18:00 18-138, K. Brückner, A. Franc, J. Gajdziok, H. Hořavová, K. Kubová, M. Pavelková, J. Vysloužil, J. Zeman
Předpoklady
FAKULTA(FaF) || OBOR(MUSFaF)
Omezení zápisu do předmětu
Předmět je určen pouze studentům mateřských oborů.
Mateřské obory/plány
Cíle předmětu
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.
Výstupy z učení
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
Osnova
  • SYLLABUS OF LECTURES
    1.Pharmaceutical solutions.
    2. Eye preparations.
    3. Nasal and ear preparations.
    4. Water for pharmaceutical purposes, sterilization methods.
    5. Parenteral dosage forms.
    6. Pharmaceutical emulsions.
    7 Pharmaceutical suspensions.
    8. Plants extracts and extraction methods.
    9. Powders and their characteristics.
    10. Capsules, their production, and evaluation.
    11. Semisolid dosage forms – ointments.
    12. Semisolid dosage forms - creams, gels, pastes.
    13.Pharmaceutical packaging.

    Topics of laboratory classes
    1. Pharmaceutical calculations
    2. Introduction to the practical training. Medicinal solutions: preparation at room and higher temperature, evaluation.
    3. Medicinal solutions: preparation by solubilization and chemical reaction, evaluation.Test - Pharmaceutical calculations.
    4. Syrups. Preparation and evaluation.
    5. Gels, mucillages. Preparation and evaluation
    6. Eye drops. Preparation and evaluation.
    7. Nasal and ear drops. Preparation and evaluation.
    8. Emulsions. Preparation and evaluation. Test - calculations for eye, nasal preparations.
    9. Suspensions. Preparation and evaluation.Test - emulsifiers.
    10. Preparation of liquid dosage forms according to prescriptions.
    11. Divided and non-divided pharmaceutical powders. Preparation and evaluation.
    12. Alternative training.
    13. Credit test, Laboratory skills testing
Literatura
    povinná literatura
  • The texts are available during the lectures. info
    doporučená literatura
  • 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
  • European Pharmacopoeia, 9th Edition. 2017. info
  • Rowe, Sheskey, Owen. Handbook of Pharmaceutical Excipients. Great Britain, 2006. ISBN 1-58212-058-7. info
    neurčeno
  • TEIXEIRA, Maria Glaucia a Joel L. ZATZ. Pharmaceutical calculations. Fifth edition. Hoboken, New Jersey: Wiley, 2017, 1 online. ISBN 9781118978535. URL info
Výukové metody
Lectures
Lab training - preparation of dosage forms, discussion of the technological process and use of the product
Home study as preparation for practical classes
Metody hodnocení
Intermediate tests in laboratory exercises (3 tests, two retakes is 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 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 labelling of the product - shelf life, storage conditions).
Vyučovací jazyk
Angličtina
Navazující předměty
Informace učitele
Lectures are recommended due to lack of suitable literature.
Laboratory classes are obligatory (100 %).
Credit for courses will only be awarded where a student will:
- participate in 100% of 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
- complete successfully credit test in the end of the course
- complete successfully testing of laboratory skill in the end of the course.
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