KE517: Drug Formulation and Production A (10 ECTS)

STADS: 10004901

Level
Bachelor course

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

Teacher responsible
Email: kuntsche@ifk.sdu.dk

Additional teachers
annette@ifk.sdu.dk
mmb@ifk.sdu.dk

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

Prerequisites:
None

Academic preconditions:
The Science year must be passed. BMB525 - Microbiology for Pharmaceutical Science and BB523 Pharmaceutical toxicology A are recommended known.

Course introduction
The aim of the course is to introduce students to essential drug dosage forms and ways of application along with the influence of both the active and inactive ingredients´ chemical and physicochemical characteristics for the drug´s biopharmaceutical performance, applicability and storage stability.

Expected learning outcome
After completed course, the students are expected to be able to:

• Document principle knowledge of ways of drug application and explain essential characteristics and use of drug dosage forms.
  
• Describe general principles and methods for drug dosage form design
  
• Understand general characteristics and use of common excipients
  
• Document a general understanding of GMP related requirements to drug quality.
  
• Discuss and judge the influence of the dosage form on a drug´s bioavailability.
  
• Discuss characteristics, challenges, and quality issues in relation to drug packaging.
  
• Communicate their knowledge on drug dosage forms and dosage form design with respect to application, effect, side effects and patient compliance to patients, health care professionals, the public, and authorities.

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

• M.E. Aulton: The Design And Manufacture of Medcines, Aulton´s Pharmaceutics, 3rd ed.

Syllabus
See syllabus.

Website
This course uses e-learn (blackboard).

Prerequisites for participating in the exam
None

Assessment and marking:
a) Mandatory participation in 28 hours’ laboratory exercises as well as approval of individual reports. Internal evaluation by the teacher, pass/fail.
b) 4 hour written examination with all aids (books, notes and calculater) after 2nd quarter. External marking with 7-scale.

Re-examination after 4th quarter.
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.

48 forelæsninger, 28 laboratorieøvelsestimer og 6 eksaminatorietimer. 1-dags Ekskursion.
6 timer af laboratorieøvelserne vil foregå som teoretiske øvelser.
Educational activities

Language
This course is taught in Danish.

Course enrollment
See deadline of enrolment.

Tuition fees for single courses
See fees for single courses.