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: 11-11-2019
Duration: 1 semester
Version: Archive
Comment
Entry requirements
Academic preconditions
Students taking the course are expected to:
Have knowledge of FA502
Be able to apply knowledge from 1st year pharmacy courses.
Course introduction
The course aims to give participants knowledge of selected solid pharmaceutical forms (such as powders, granules, capsules and tablets), in particular focusing on formulation principles and manufacturing methods, requirements in the European Pharmacopoeia, the importance of the physico-chemical and chemical properties of pharmaceuticals and excipients. physical and biopharmaceutical characteristics and quality of drugs.
This is important in relation to quality of solid medicines.
The course builds on the knowledge gained in the courses FA502, and provides a professional basis for studying the topics Fa504, which is located later in the program.
In relation to the education's competency profile, the course explicitly focuses on:
- Provide competence to explain the quality of solid drugs and carry out quality control
- Give knowledge about solid 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. Pharmacopoeia Europaeia) 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 some examples of commercial drugs into this perspective.
Content
The course contains the following main Scientific areas:
- General aspects of solid drug formulations (definitions, general functions of the drug formulations and routes of administration, general biopharmaceutical, physicochemical and therapeutic issues)
- Formulation and industrial manufacture of solid pharmaceutical forms (powder, granules, capsules and tablets)
- Physico-chemical principles of importance for the various drug forms (e.g. solid state properties, particle size, surface properties, powder flow, compression properties, solubility, etc.)
- Functions and structures of important excipients / auxiliary groups for the various drug forms mentioned above
- evaluation of solid drugs
- Relevant requirements and monographs of the European Pharmacopoeia (Ph.Eur.) For the different pharmaceutical forms mentioned above
Literature
Churchill Livingstone Elsevier: Aulton’s Pharmaceutics.
See Blackboard for syllabus lists and additional literature references.
See Blackboard 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' on Blackboard.
Dansk
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
Reports for all 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 under 'Course Information' on Blackboard.
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 45 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, joint assesmnent.
The examination form for re-examination may be different from the exam form at the regular exam.
Indicative number of lessons
Teaching Method
Teaching activities result in an estimated indicative distribution of the work performance of an average student as follows:
- Intro phase (lecture, class hours) - Hours: 22
- Training phase: Number of hours: 22, including 6 hours of examination and 16 hours of laboratory
Teaching methods:
- The course consists of three sections where the contents of the first and second sections are included in the third section and everyone prepares for the exam
- Introduction to topics as well as its perspective is offered in the form of lectures with demonstrations
- Section 2 builds on this and is a theoretical aftermath of Section 1 with self-study with own learning that is not scheduled
- Deepening and / or visualization for selected topics follows in section 3 the form of a review of theoretical and practical examples (E-hours, Lab)
Activities in the study phase:
- 56 hours of reading, problem solving and group work
- Deepening and post-work from lectures and lab exercises
- Training in text book understanding; correlation between current Ph.Eur. monographs and text book 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 |