KE517: Drug Formulation and Production A (10 ECTS)

STADS: 10004901

Level
Bachelor course

Teaching period
The course is held twice a year, once in the autumn semester and once in the spring semester.
The course begins in the spring semester and continues in the autumn semeter. 4th and 1st quarter.

Teacher responsible
Email: kuntsche@sdu.dk

Additional teachers
mmb@sdu.dk
annette.bauer@sdu.dk
mdc@sdu.dk

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

Prerequisites:
None

Academic preconditions:
The Science year must be passed. BMB528 - Microbiology for Pharmaceutical Science is 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 properties with regard to 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
• 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.
• Document a general understanding of legal requirements in quality assurance of the production of pharmaceutical dosage forms (relevant monographs and methods of the Ph.Eur. and DLS, principles of GMP).
• 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 routes of administration will be communicated.

• Physico-chemical and biopharmaceutical properties of active ingredients and their impact on the design and methods applied for drug formulation and production and drug stability.
• Most common excipients, its physico-chemical properties and its application/function.
• Introduction into commonly used dosage forms, their formulation and production.
• Overview about most common package materials of pharmaceutical products.
• Introduction into methods of quality assurance for pharmaceutical dosage forms.
• Excursion to a relevant pharmaceutical manufacturer.

Literature

• Churchill Livingstone Elsevier: Aulton’s Pharmaceutics, 3rd edition,2007.
• Europæiske Farmakopé (Ph.Eur.). : Europæiske Farmakopé (Ph.Eur.). Danske Lægemiddelstandarder (DLS)., Kursusmaterialer (skal ligge på e-learn). .

Website
This course uses e-learn (blackboard).

Prerequisites for participating in the exam
None

Assessment and marking:

1. Active and successful participation in 33 hours’ laboratory exercises and 6 hours seminars including approval of individual reports and theoretical exercises. (pass/fail, internal evaluation by the teacher). 
2. 4 hour written examination with all aids (books, notes and calculator) after 1st quarter. External marking with 7-scale.

* Active and successful participation includes:
• 80% attendance
• Carrying out the practical exercises (lab-course) in an adequate quality (the exercises will be evaluated passes/not passed, internal evaluation)
• Solving theoretical questions in connection with the seminars and handing over of satisfactory lab-protocols on schedule (laboratory exercises) (the exercises will be evaluated passed/not passed, internal evaluation)

Re-examination after 2nd 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.

46 timer forelæsninger, 33 timer obligatoriske laboratorieøvelser (10 timer af laboratorieøvelserne vil foregå som teoretiske øvelser) og 6 obligatoriske og 6 ikke obligatoriske eksaminatorietimer. 1-dags ekskursion.

(De angivne timetal er vejledende og der vil derfor kunne forekomme afvigelser).
Educational activities

Language
This course is taught in Danish or English, depending on the lecturer. However, if international students participate, the teaching language will always be English.

Course enrollment
See deadline of enrolment.

Tuition fees for single courses
See fees for single courses.