FA503: Drug formulation and production B
Study Board Pharmacy
Teaching language: Danish or English depending on the teacher, but English if international students are enrolled
EKA: N560007112, N560007122, N560007102
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: 30-10-2020
Duration: 1 semester
Version: Archive
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 impact of the physico-chemical and chemical properties of pharmaceutical 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 functions of the dosage forms and routes of administration, general chemical, physico-chemical, biopharmaceutical and therapeutic issues)
- Formulation and industrial manufacture of solid pharmaceutical forms (powders, granules, capsules and tablets)
- Impact 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.)
- Functions and chemical structures of important excipients for use in the various dosage forms mentioned above
- Evaluation 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
Student Identification Card
Language
Normally, the same as teaching language
Examination aids
A closer description of the exam rules will be posted under 'Course Information' ,”Course Materials” and/or “Announcements“ on Blackboard.
ECTS value
0
Additional information
The prerequisite examination is a prerequisite for participation in exam element a)
Exam element a)
Timing
Spring
Prerequisites
| Type | Prerequisite name | Prerequisite course |
|---|---|---|
| Examination part | Prerequisites for participating in the exam element a) | N560007101, FA503: Drug formulation and production B |
Tests
Approval of reports for lab exercises and home assignments with acceptable answers
EKA
N560007122
Assessment
Second examiner: None
Grading
Pass/Fail
Identification
Full name and SDU username
Language
Normally, the same as teaching language
Examination aids
Allowed, a closer description of the exam rules will be posted in itslearning.
ECTS value
1
Additional information
The examination form for re-examination may be different from the exam form at the regular exam.
Exam element b)
Timing
June
Tests
Portfolio
EKA
N560007102
Assessment
Second examiner: External
Grading
Pass/Fail
Identification
Student Identification Card
Language
Normally, the same as teaching language
Duration
Written MC test 30 min.
Oral exam 10 min.
Examination aids
No aids allowed for MC; 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.
The examination form for re-examination may be different from the exam form at the regular exam.
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 |