FA502: Drug formulation and production A (5 ECTS)

STADS: 03000101

Level
Bachelor course

Teaching period
The course is offered in the autumn semester.

Teacher responsible
Email: kuntsche@sdu.dk

Timetable
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Prerequisites:
None

Academic preconditions:
None

Course introduction
The aim of the course is to provide the participants with knowledge about the selected dosage forms (solutions, emulsions, suspensions and semi-solid formulations) with special focus on their formulation principles and production, on the requirements of the European Pharmacopoeia (Ph.Eur.) as well as the Danish Drug Standards (Danske Lægemiddelstandarder) as well as on the impact of the physicochemical and chemical properties of the drug and pharmaceutical excipients on the physical and biopharmaceutical characteristics of the dosage form and its stability.

Qualifications

• To demonstrate a knowledge and understanding of the requirements of the Ph.Eur. and properties of selected dosage forms (solutions, emulsions, suspensions and semi-solid formulations) together with their formulation principles and stability
• To discuss the use of pharmaceutical excipients with regards to different dosage forms
• To explain and discuss the function of pharmaceutical excipients in commercially available medicines
• To apply and discuss fundamental biopharmaceutical principles and definitions
• To manufacture dosage forms in small scale together with documentation of the manufacturing process

Expected learning outcome
(see competences)

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 liquid preparations for oral and cutaneous administration (solutions, emulsions and suspensions), semi-solid formulations for cutaneous application and herbal drugs
• Physicochemical principles of the different dosage forms (solutions, suspensions, emulsions, solubility, solubilization, interfacial tension, rheology)
• Relevant requirements and monographs of the European Pharmacopoeia (Ph.Eur.) and the Danish Drug Standards (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)

Literature

• Churchill Livingstone Elsevier: Aulton’s Pharmaceutics
• 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
Participation in tutorials and laboratory exercises is a prerequisite for taking part in the examinations. Pass/fail, internal evaluation by teacher.

Assessment and marking:

1. Home assignments and reports with acceptable replies for all assignments and reports. Pass/fail, internal evaluation by teacher (1 ECTS).
2. 2 written tests without aids (calculator allowed) and a home assignment. Overall assessment, external censorship, Danish 7-mark scale (4 ECTS).

Reexamination in the same exam period or immediately thereafter. The mode of reexamination may differ from the mode of the ordinary exam.

Expected working hours
The teaching method is based on three phase model.
Intro phase: 22 hours
Skills training phase: 28 hours, hereof:
 - Tutorials: 4 hours
 - Laboratory exercises: 24 hours

Educational activities Study phase: 50 hours

Language
This course is taught in Danish or English, depending on the lecturer.

Course enrollment
See deadline of enrolment.

Tuition fees for single courses
See fees for single courses.