KE517: Drug Formulation and Production A (10 ECTS)

STADS: 10007801

Level
Bachelor course

Teaching period
The course begins in the spring semester and continues in the autumn semester.

Teacher responsible
Email: kuntsche@sdu.dk

Additional teachers
mmb@sdu.dk
annette.bauer@sdu.dk
mdc@sdu.dk

Timetable
Show entire timetable
Show personal time table for this course.

Prerequisites:
None

Academic preconditions:
The Science year must be passed. BMB528 - Microbiology for Pharmaceutical Science is recommended known.

Course introduction
The aim of the course it to provide the participants with knowledge about the fundamental dosage forms with special focus on their formulation principles and production, about the requirements of the European Pharmacopoeia (Ph.Eur.) as well as the Danske Lægemiddelstandarder and about the impact of the physicochemical and chemical properties of active pharmaceutical ingredients and pharmaceutical excipients on the physical and biopharmaceutical characteristics of the dosage form and their stability.

Expected learning outcome
After the course, the student is expected to be able to:

• demonstrate a broad overview over the requirements of the Ph.Eur. and properties of fundamental dosage forms together with their formulation principles and stability,
• discuss the use of pharmaceutical excipients with regards to different dosage forms,
• explain and discuss the function of pharmaceutical excipients in commercially available medicines,
• apply and discuss fundamental biopharmaceutical principles and definitions, and
• manufacture dosage forms in small scale together with documentation of the production.

Subject overview

• General aspects on dosage forms (definitions, general functions of dosage forms, administration routes, general biopharmaceutical, physicochemical and therapeutic considerations)
• Formulation and production of different dosage forms (liquid preparations for oral and cutaneous administration, powders, granules, tablets, capsules, parenteralia, eye preparations, semi-solid formulations for cutaneous application, herbal drugs, suppositories)
• Physicochemical principles of the various dosage forms (solutions, suspensions, emulsions, solubility, solubilization, rheology, solid-state properties)
• Microbiological quality of pharmaceutical preparations together with antimicrobial preservation and disinfection 
• Relevant requirements and monographs of the European Pharmacopoeia (Ph.Eur.) and the Danske Lægemiddelstandarder (DLS) with regard to the different dosage forms mentioned above
• Functions and structures of important pharmaceutical excipients and groups of excipients with regard to their function in the different dosage forms mentioned above
• Extemporaneous preparations (DLS, documentation)
• Biopharmaceutical aspects (bioavailability, LADME, plasma concentration curves together with relevant pharmacokinetic parameters, bioequivalence, dosage regimes)
• Packing materials and stability

Literature

• Churchill Livingstone Elsevier: Aulton’s Pharmaceutics, 3rd edition, 2007.
• Europæiske Farmakopé (Ph.Eur.). : Europæiske Farmakopé (Ph.Eur.). Danske Lægemiddelstandarder (DLS), Kursusmaterialer (skal ligge på e-learn)..

Website
This course uses e-learn (blackboard).

Prerequisites for participating in the exam
Mandatory assignments and a test. The assignments and test must be passed in order to participate in the laboratory exercises and the written exam.
Passed/failed, internal evaluation by teacher. (0 ECTS)

Assessment and marking:

1. 36 mandatory lab-exercises together with acceptance of 5 reports and a practical test at the end (preparation of a dosage form and documentation of preparation). Passed/failed, internal examination with teacher. (0 ECTS)
2. 2 hours written digital exam without aids (calculator is allowed) after the 1st quarter. External examination. Marks according to the Danish 7-point marking scale. (10 ECTS)

Re-examination in the same exam period or immediately thereafter. The mode of exam at the re-examination may differ from the mode of exam at the ordinary exam.

Expected working hours
The teaching method is based on three phase model.
Intro phase: 46 hours
Skills training phase: 51 hours, hereof:
 - Tutorials: 14 hours
 - Laboratory exercises: 36 hours

Educational activities Study phase: 152 hours

Language
This course is taught in Danish or English, depending on the lecturer. However, if international students participate, the teaching language will always be English.

Course enrollment
See deadline of enrolment.

Tuition fees for single courses
See fees for single courses.