KE516: Drug Formulation and Production B (5 ECTS)

STADS: 10009001

Level
Bachelor course

Teaching period
The course is offered in the autumn semester.

Teacher responsible
Email: annette.bauer@sdu.dk
Email: cun@sdu.dk

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

Prerequisites:
Passed 1. year annual examination.

Academic preconditions:
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 tablets and dissolution studies, 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, tablets, liquid drug formulations (infusions, injections, eye drops), suppositories and emulsions will be produced and studied.
• 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
Successfully passing of a written test to asses students’ theoretical knowledge is mandatory to obtain access to the laboratory exercises. (10009012)

Assessment and marking:

1. Attendance of a minimum of 6 out of 8 tutorial (seminars) hours;
2. Mandatory assignments (includes home assignments, problem solving and MCO quiz (or test));
3. Participation to all laboratory exercises including approval of all required reports.

Joint evaluation of a, b and c. Pass/not pass, internal evaluation by the teachers.

Reexamination 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: 28 hours
Skills training phase: 26 hours, hereof:
 - Tutorials: 8 hours
 - Laboratory exercises: 18 hours

Educational activities

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.