KE516: Drug Formulation and Production B (5 ECTS)

STADS: 10001701

Level
Bachelor course

Teaching period
The course is offered in the spring semester.
4 th. quater

Teacher responsible
Email: ellen@ifk.sdu.dk

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

Revison of timetable:
: Lab mandag uge 19 er rykket en time frem.

Prerequisites:
None

Academic preconditions:
Passed 1. year annual examination.
Knowledge about KE504 Analytical Spectroscopy, BB523 Pharmaceutical Toxicology, BMB525 Microbiology for Pharmaceutical Science, KE517 Drug Formulation and Production A is recommended.

Course introduction
In the lab course for pharmaceutical technology the students will intensify their theoretical knowledge and gain first practical experience in the formulation and characterization of drug formulations. Different solid (powders, granulates, capsules, and microparticals), semi-solid (topicals), and liquid (emulsions, suspensions, liquids for infusion and injections, as wells as eye drops) dosage forms will be prepared using the standard operation procedures and most commonly applied excipients. The stability of the corresponding drug formulation (chemical / biological / physical) during the processing and/or short-time storage, the accuracy and conformity of mass, and the conformity of form and appearance will be tested when indicated, in order to evaluate the production process and product quality. In experiments the students will test the influence of formulation/storage conditions and/or drug-excipient interactions on the drug stability and/or drug release, and discuss their relevance for the quality and functionality of drug formulations. As far as suitable, the drug production and characterization will be performed in view of the concepts for quality insurance described in the EU-GMP and/or ICH guide lines (validation, quality control of products and manufacturing processes, documentation).

Expected learning outcome
At the end of the course the student will be able to:

• have an overview of the standard operation procedures for drug formulation, methods for the small-scale on-demand drug production and the basic principles of quality insurance.
• gain an insight into the influence of the physico-chemical properties of ingredients and drug formulations, on the formulation design and methods, on the drug stability and biopharmaceutical properties of the drug formulation.
• have an overview of the most common excipients, its physico-chemical properties and its application/function.

Subject overview
• Based on the descriptions of the Ph.Eur. and the DLS, solid (powders, granulates, capsules, microparticles), semi-solid (topics), and liquid drug formulation (infusions, injections, eye drops, emulsions, suspensions) will be produced.
• A practical experience in the basic formulation techniques of milling, blending, granulating, sterile/filtering, and sterilizing will be transferred focussing on equipment usually available in hospital pharmcies.
• The impact of the drug formulation process, excipients used, the production/storage conditions, and drug-excipient-interactions on drug stability and product quality will be demonstrated in experiments.

Literature

Udsendes på Blackboard.

Website
This course uses e-learn (blackboard).

Prerequisites for participating in the exam
None

Assessment and marking:
Lab. work. Pass/fail, internal evaluation by teacher.

Expected working hours
The teaching method is based on three phase model.

42 laboratorieøvelser. 6 eksaminatorietimer/opgaveregning.
Educational activities

Language
No recorded information about the language used in the course.

Course enrollment
See deadline of enrolment.

Tuition fees for single courses
See fees for single courses.