FA503: Drug formulation and production B
Study Board Pharmacy
Teaching language: English, but not offered to international students
EKA: N560007112, N560007102, N560007122
Assessment: Second examiner: None, Second examiner: External
Grading: Pass/Fail
Offered in: Odense
Offered in: Spring
Level: Bachelor
STADS ID (UVA): N560007101
ECTS value: 5
Date of Approval: 13-10-2022
Duration: 1 semester
Version: Approved - active
Comment
Entry requirements
Academic preconditions
Students taking the course are expected to:
- Have knowledge of FA511
- Be able to apply knowledge from 1st year pharmacy courses.
Course introduction
The course aims to give the participants knowledge about selected solid dosage forms (such as powders, granules, capsules and tablets), in particular focusing on formulation principles and manufacturing methods, requirements in the European Pharmacopoeia as well as the significance of the physico-chemical and chemical properties of active pharmaceutical ingredients and excipients on the physical and biopharmaceutical characteristics and quality of dosage forms.
The course builds on the knowledge gained in the courses FA501, FA511 and KE538 and provides a basis for studying the topics in FA504, which is located later in the study program.
In relation to the education's competency profile, the course explicitly focuses on:
- Providing competence to explain manufacturing and quality of solid dosage forms and to carry out quality control
- Giving knowledge about selected solid dosage forms and medicines
Expected learning outcome
The learning objective of the course is that the student demonstrates the ability to:
- Define and describe the most commonly used solid dosage forms
- Demonstrate knowledge and understanding of the properties of selected drug dosage forms (solid formulations such as powders, granules, capsules, and tablets)
- Explain the quality of medicines, quality requirements (cf. European Pharmacopoeia) and quality control.
- Explain the formulation principles and explain the structure of solid dosage forms.
- Discuss the use of excipients / groups of excipients for the various drug dosage forms.
- Explain and discuss the functions of excipients in commercial drugs.
- Explain production methods on both small scale and industrial scale for the mentioned dosage forms
- Apply and discuss basic biopharmaceutical principles and definitions for oral drugs.
- Put selected commercial drugs into the above- mentioned perspectives.
Content
The course contains the following main topics:
- General aspects of solid dosage forms (definitions, general functionality of the dosage forms and routes of administration, general chemical, physico-chemical, biopharmaceutical and therapeutic issues)
- Formulation and industrial manufacture of solid dosage forms (powders, granules, capsules and tablets)
- Significance of the physico-chemical principles for the various dosage forms (e.g. solid state properties, particle size, surface properties, powder flow, compression properties, solubility, etc.)
- Functionality and chemical structures of important excipients and groups of excipients for use in the various dosage forms mentioned above
- Quality tests of solid dosage forms with respect to biopharmaceutical aims and quality
- Relevant requirements and current monographs of the European Pharmacopoeia (Ph.Eur.) for the different dosage forms mentioned above
Literature
- Churchill Livingstone Elsevier: Aulton’s Pharmaceutics.
- European Pharmacopoeia (Ph.Eur.).
See itslearning for syllabus lists and additional literature references.
Examination regulations
Prerequisites for participating in the exam element a)
Timing
Spring
Tests
Participation in tutorials and laboratory exercises
EKA
N560007112
Assessment
Second examiner: None
Grading
Pass/Fail
Identification
Full name and SDU username
Language
Normally, the same as teaching language
Examination aids
To be announced during the course
ECTS value
0
Additional information
The prerequisite examination is a prerequisite for participation in exam element a)
Exam element b)
Timing
June
Tests
Portfolio with oral defense
EKA
N560007102
Assessment
Second examiner: External
Grading
Pass/Fail
Identification
Student Identification Card
Language
Normally, the same as teaching language
Duration
Written MCQ test 30 min.
Oral exam 10 min.
Oral exam 10 min.
Examination aids
Written MCQ exam
The exam is without aids. However, it is allowed to use the standard build in calculator in Windows/MAC.
Internet is not allowed during the exam. However, you may the course site in itslearning in connection with filling out the multiple-choice questions.
The exam is without aids. However, it is allowed to use the standard build in calculator in Windows/MAC.
Internet is not allowed during the exam. However, you may the course site in itslearning in connection with filling out the multiple-choice questions.
Oral Exam:
All aids except for communication with others allowed for the oral part of the examination.
ECTS value
4
Additional information
Portfolio consisting of written MC test and oral exam with joint assessment.
Re-examination: If nine or fewer people register, the reexamination is changed to only oral and the MCQ test lapses.
Re-examination: If nine or fewer people register, the reexamination is changed to only oral and the MCQ test lapses.
Exam element a)
Timing
Spring
Prerequisites
| Type | Prerequisite name | Prerequisite course |
|---|---|---|
| Prerequisite not found |
Tests
Laboratory reports and home-assignments
EKA
N560007122
Assessment
Second examiner: None
Grading
Pass/Fail
Identification
Full name and SDU username
Language
Normally, the same as teaching language
Examination aids
To be announced during the course
ECTS value
1
Additional information
Approval of reports for lab exercises and home assignments with acceptable answers
Indicative number of lessons
Teaching Method
- Intro phase (lectures): Hours: 16
- Training phase: Number of hours: 28, including 12 hours of tutorials and 16 laboratory hours
Activities in the study phase (app. 93 hours):
- Reading the syllabus and solving exercises
- Absorption and pre- and post-work from lectures and lab exercises
- Training in textbook understanding; correlation between current Ph.Eur. monographs and textbook knowledge
- Task calculations based on pharmaceutical forms and current official tests
- Perspective from lab scale to industry scale
Teacher responsible
| Name | Department | |
|---|---|---|
| Annette Bauer-Brandl | annette.bauer@sdu.dk | Institut for Fysik, Kemi og Farmaci |
Timetable
Administrative Unit
Team at Educational Law & Registration
Offered in
Recommended course of study
Transition rules
Transitional arrangements describe how a course replaces another course when changes are made to the course of study.
If a transitional arrangement has been made for a course, it will be stated in the list.
See transitional arrangements for all courses at the Faculty of Science.