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 quarter

Teacher responsible
Email: annette.bauer@sdu.dk

Additional teachers
mmb@sdu.dk
kuntsche@sdu.dk
mdc@sdu.dk

Timetable
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Revison of timetable:
: Skema er under opdatering og endnu ikke endeligt.

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
The aim of the course is to introduce the students to the influence of the active ingredient´s physical and chemical and most commonly applied excipients, overlaying production processes, and methods of quality assurance described in the EU-GMP and/or ICH guIde lines (Validation, quality control of manufacturing processes and product, documentation).

In the lab course the students will intensify their theoretical knowledge and gain practical experience in the formulation and characterization of granulates, capsules, tablets, solutions, liquids for infusion and injection as well as eye drops. The students will learn about the influence of formulation on drug stability (chemical, biological and physical) and product quality. In experiments the students will test the influence of formulation on the quality and safety of the finished product. 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.

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

• have an overview of the standard operation procedures and equipment applied for different drug formulations
• Demonstrate an understanding of quality assurance and validation of drug formulations

Subject overview

• Based on the descriptions of the Ph.Eur. and the DLS, drug formulations like granulates, capsules and liquid drug formulations (infusions, injections, eye drops) will be produced.
• Theoretical background knowledge of commonly used standard operation procedures like blending, granulating, drying, compression, coating, filtering, sterile filtering and sterilization, as well as the principles of process and product control will be discussed with a focus on the methods and equipment applied for drug production.
• A practical experience in the basic formulation techniques of blending, granulating, sterile/filtering, and sterilizing will be transferred focusing on equipment usually available in hospital pharmacies.
• The impact of the drug formulation process excipients used and the production/storage conditions 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:
Mandatory tutorials (seminars) and assignments, as well as mandatory reports and lab exercises are evaluated collectively, passed/failed, internal censorship by lecturer.

Reexamination after second quarter

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

28 forelæsninger
20 Laboratorieøvelser
6 eksaminatorietimer/seminarer
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.