FaF:FAFO2_13 Dosage Forms and Biopharmacy - Course Information

FAFO2_13 Dosage Forms and Biopharmacy II

Extent and Intensity

3/6/0. 11 credit(s). Type of Completion: zk (examination).
Taught in person.

Teacher(s)

doc. PharmDr. Aleš Franc, Ph.D. (lecturer)
doc. PharmDr. Jan Gajdziok, Ph.D. (lecturer)
doc. PharmDr. Kateřina Kubová, Ph.D. (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. Jakub Vysloužil, Ph.D. (seminar tutor)
PharmDr. Miroslava Pavelková, Ph.D. (seminar tutor)
PharmDr. Kateřina Tenorová, Ph.D. (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

Prerequisites

FAFO1_13 Dosage Forms and Biopharmacy
Dosage Forms and Biopharmacy I
Students can study this course only after completing the course Dosage Forms and Biopharmacy I

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 20 student(s).
Current registration and enrolment status: enrolled: 0/20, only registered: 0/20

fields of study / plans the course is directly associated with

• Multidisciplinary studies at Faculty of Pharmacy (programme CST, KOS)
• Pharmacy (programme FaF, M-FARMA)

Course objectives

One of the main obligatory pharmaceutical disciplines dealing with the preparation, manufacturing, and quality control of medicaments including technological procedures, equipment, excipients, and appropriate analytical devices. It covers the influence of the application form on drug bioavailability.

Learning outcomes

After completing the course, the student will:
- describe the theoretical aspects of semisolid dosage forms formulation and quality testing;
- describe the classification, requirements, excipients, and technological process of preparation and production of solid dosage forms, including their evaluation;
- theoretically describe the classification, requirements, excipients, technological process of preparation and production of dosage forms with controlled drug release, including their evaluation;
- know the basic aspects of semisolid and solid dosage forms about the drug bioavailability;
- describe the main conditions of GMP
- recognize selected incompatibilities in liquid and semisolid dosage forms and adjust the composition of pharmaceutical products;
- prepare semisolid (ointments, cremes, pastes, gels) and solid dosage forms (powders, granules, capsules, suppositories, vaginal globules) in pharmacy conditions

Syllabus

• Topic of lecture
  Dosage forms for rectal application
  Dosage forms for vaginal application
  Granules, granulation methods. Evaluation of powders and granules
  Tablets, their production, and evaluation
  Pharmaceutical packaging
  Pharmaceutical incompatibilities in dosage forms
  Coated products, their production and evaluation
  Development of new drugs from galenical perspective
  Multiple-unit drug delivery systems
  Pharmaceutical aerodispersions
  Transdermal preparations
  Validation in pharmaceutical technology
  Controlled drug release
  Good manufacturing practice in pharmacy
  
  Practical labs
  Semisolid dosage forms - Ointments
  Semisolid dosage forms - Creams
  Semisolid dosage forms - Pastes, Gels
  Test - semisolid preparation. Rectal and vaginal dosage forms - theoretical aspect of preparation
  Rectal and vaginal dosage forms
  Technological processes in preparation of difficult prescriptions I. Test - suppositories, vaginal globules.
  Technological processes in preparation of difficult prescriptions II.
  Divided and non-divided pharmaceutical powders. Preparation and evaluation
  Alternative training
  Wet and melt granulations
  Tablets preparation by direct compression
  Evaluation of solid dosage forms
  Fluid bed granulation
  Credit test, Laboratory skills testing
  

Literature

required literature
• KUBOVÁ, Kateřina, Aleš FRANC, Jan GAJDZIOK, Martina KEJDUŠOVÁ and David VETCHÝ. Medical forms and biopharmacy - I. Liquid and Semi-Solid Dosage Forms. 1st ed. Brno: Farmaceutická fakulta Veterinární a farmaceutické univerzity, 2014, 125 pp. ISBN 978-80-7305-671-1. URL info
• KUBOVÁ, Kateřina, Aleš FRANC, Jan GAJDZIOK, Martina KEJDUŠOVÁ and David VETCHÝ. Medical forms and biopharmacy - II. Solid Dosage Forms. Brno: Farmaceutická fakulta Veterinární a farmaceutické univerzity, 2014, 87 pp. skripta. ISBN 978-80-7305-757-2. URL info
• The texts which are available during the lectures. info

recommended literature
• European Pharmacopoeia 11
• MAHATO, Ram I. Pharmaceutical dosage forms and drug delivery. Boca Raton, FL: CRC Press, 2007, xxxi, 300. ISBN 0849392853. info
• 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
• Handbook of Pharmaceutical Excipients. Great Britain, 2006. ISBN 1-58212-058-7. info

Teaching methods

1Lectures - powerpoint presentations
2 Individual lab training - practical skills

Assessment methods

Intermediate tests in laboratory classes
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.
Oral examination (study topics are available in the study materials in IS MU)

Language of instruction

English

Further comments (probably available only in Czech)

The course can also be completed outside the examination period.

Teacher's information

Lectures are recommended due to the lack of suitable literature. Students can study this course only after completing the course Dosage Forms and Biopharmacy I
All study materials are available in IS MU.

• Enrolment Statistics (Spring 2025, recent)
  
• Permalink: https://is.muni.cz/course/pharm/spring2025/FAFO2_13