KE517: Drug Formulation and Production A (10 ECTS)

STADS: 10001801

Level
Bachelor course

Teaching period
The course is offered in the autumn semester.
1st and 2nd quarter

Teacher responsible
Email: ebp@ifk.sdu.dk

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

Comment:
Yderligere underviser:
Torben Henriksen, Ekstern lektor, cand.pharm. email: tv8@galnet.dk

Prerequisites:
None

Academic preconditions:
KE501 Fundamental chemistry, FY501 The Changing Nature and KE504 analytical spectroscopy must be passed. BMB525 - Microbiology for Pharmaceutical Science and BB523 Pharmaceutical toxicology A are recommended

Course introduction
The lecture is aimed at introducing the students to the most important drug dosage forms, and the impact of the physico-chemical and biopharmaceutical properties of active ingredients and excipients on the drug stability, its clinical application, their therapeutic effect, as well as the types of drug administration.
The lecture is aimed to overview the standard manufacturing operations, overlaying production processes, and methods of quality assurance covering all steps of drug production (GMP guide lines, validation, quality control of manufacturing processes and products, documentation).

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

• demonstrate an overview of the most common drug formulations, its properties and use, as well as the types of drug administration.
• give an account of methods and equipment of drug production.
• explain the introduced standard operations and manufacturing processes.
• give an account of the most common excipients and its application.
• demonstrate an understanding of the importance of GMP for pharmaceutical drug production and can develop strategies for GMP-conform manufacturing.
• Explain properties for, problems around, and quality assurance of packing.

Subject overview
Based on the descriptions of the Ph.Eur. and the DLS, the drug formulation and types of administration will be communicated.
• The theoretical knowledge about the basic formulation techniques of milling, blending, granulating, drying, pelleting, coding, 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.
• The physico-chemical and biopharmaceutical properties of active ingredients and its impact on the design and methods applied for drug formulation and production, and drug stability.
• The most common excipients, its physico-chemical properties and its application/function.
• The theoretical knowledge of the modern methods of quality assurance and validation of manufacturing processes and drug formulations.
• The communication of the manufacturing processes and pharmaceutical products to patients, health professionals, officials and institutions of administration with relevance of routes of drug administration, mode of action and compliance

Literature

Oplyses senere.

Syllabus
See syllabus.

Website
This course uses e-learn (blackboard).

Prerequisites for participating in the exam
None

Assessment and marking:
Written exam
1 Danish 7 mark scale, external examiner
Requires exam protocol

Examination in opposite terms: 4 hours written exam at the end of the 2nd quarter

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

84 forelæsninger og 12 eksaminatorietimer.
Educational activities

Language
This course is taught in Danish.

Remarks
The course is compulsory in the following curricula: Pharmaceutical Science
The course is optional in the following curricula: Chemistry, Biomedicine, Biochemistry and Molecular Biology

Course enrollment
See deadline of enrolment.

Tuition fees for single courses
See fees for single courses.