Drug Formulation and Delivery
Course content
The ultimate aim of drug formulation is to deliver the active pharmaceutical ingredient (API) through biological membranes to the right target in the right concentration during a defined time interval. Optimal performance of the drug formulation can be achieved by considering the physicochemical properties of API and excipients, along with both the pharmacological properties and processability of a given formulation. Understanding the most relevant factors affecting the drug product performance enables the development of an optimal pharmaceutical product.
The course will consist of 17 lectures covering different concepts related to designing a dosage form and delivering the active pharmaceutical ingredient to the right target. Lectures will cover the importance of biological and metabolic barriers related to delivery, role of preformulation/processing, and finally, the design of formulation –specific lectures will be on solid dosage forms, semisolids, inhalation products, and macromolecular delivery systems. Students will also work in small groups around given problems and summarize their problem as a presentation for other students. During the group work, students will learn how to effectively use different literature databases.
This course is a compulsory course at the Master's Programme in Industrial Drug Development.
The course is continuing professional development (CPD) intended
for professionals who are working within drug development and
manufacturing related activities.
Master’s level (second cycle higher education). Open for freelance
students who meet the admission criteria. Compulsory for MIND
students, elective for other part-time master's students.
(subject to study board approval).
Upon completion of the course, participants are expected to be able to:
Knowledge
- Demonstrate a basic knowledge about the relevant formulation strategies in connection with the route of administration when designing a dosage form
- Demonstrate a basic knowledge about the specific advantages and disadvantages of the different routes of drug administration
- Demonstrate a basic knowledge about the most important physicochemical properties of drugs and dosage forms underpinning the relevant formulation strategies
- Demonstrate a basic knowledge about the most important groups and types of excipients used in the formulation of dosage forms
- Demonstrate a basic knowledge about the most important biological and metabolic barriers related to delivery
- Demonstrate a basic knowledge about role of preformulation and processing in drug formulation and delivery
- Summarise the main processes related to formulation design.
Skills
- To choose core formulation parameters in a formulation design, based on identification of relevant physicochemical properties of active pharmaceutical ingredients (APIs)
- To choose core formulation parameters in a formulation design, based on identification of relevant physicochemical properties of excipients
- To choose core formulation parameters in a formulation design, based on identification of relevant physiological aspects related to delivery route.
Competencies
- Identify and extract the relevant information for a given drug formulation and delivery process, with respect to drug properties, excipient properties, and formulation technology.
- Work in teams and exchange knowledge with other drug development professionals when implementing basic formulation design principles in practice”
Lectures, group work, student presentations, project report.
Before the course, students should read chapters 1, 2, 8, 18, 19, 20, 21, 23, 24, 26, 27, 28, 30, 31, 36, 37, 40, 43 in the textbook “Aulton's Pharmaceutics: The Design and Manufacture of Medicines" by M.E. Aulton and K.M.G. Taylor (eds.) (Churchill Livingstone; 5th edition, 2017).
A total of approx. 250 pages + hand-outs from course presentations.
Applicants must meet the following criteria:
• A bachelor's degree, a professional bachelor’s degree, a
diploma degree, a master’s degree or equivalent within chemistry,
biochemistry, pharmacy, medicine, biomedicine, human biology,
molecular biology, veterinary sciences, health sciences, nursing,
engineering or equivalent.
• At least two years of relevant work experience related to
development of medicines
• Proficiency in English
Application deadline is 8 weeks before the day of instruction.
- ECTS
- 4 ECTS
- Type of assessment
-
Written assignment
- Type of assessment details
- Essay on a selected case of drug formulation and delivery (8-15 pages, to be submitted 6 weeks after the course). Small groups of approx. three participants will prepare a joint report.
- Exam registration requirements
-
Active participation in the course is a prerequisite.
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
- Exam period
-
Announced at the MIND programme's webpage
- Re-exam
-
The exam form for the reexam is the same as the ordinary exam. See dates in the exam schedule at the MIND programme's webpage
Criteria for exam assessment
To obtain the grade 12 the student should be able to:
Knowledge
- Demonstrate an ability to analyze, recapitulate and critically evaluate the most important literature for the selected case
- Demonstrate a correct use of the terms and concepts used in the field of drug formulation and delivery
- Demonstrate a basic knowledge about the relevant formulation strategies in connection with the route of administration when designing a dosage form
- Demonstrate a basic knowledge about the specific advantages and disadvantages of the different routes of drug administration
- Demonstrate a basic knowledge about the most important physicochemical properties of drugs and dosage forms underpinning the relevant formulation strategies
- Demonstrate a basic knowledge about the most important groups and types of excipients used in the formulation of dosage forms
- Demonstrate a basic knowledge about the most important biological and metabolic barriers related to delivery
- Demonstrate a basic knowledge about role of preformulation and processing in drug formulation and delivery
- Summarise the main processes related to formulation design.
Skills
- Critically evaluate the route of administration and dosage form design for an existing formulation presented in group work
- Choose core formulation parameters in a formulation design, based on identification of relevant physicochemical properties of active pharmaceutical ingredients (APIs), relevant physicochemical properties of excipients, and relevant physiological aspects related to delivery route.
- Present relevant alternatives to this existing formulation.
Competencies
- Identify and extract the relevant information for a given drug formulation and delivery process, with respect to drug properties, excipient properties, and formulation technology.
- Work in teams and exchange knowledge with other drug development professionals when implementing basic formulation design principles in practice.
Part time Master and Diploma courses
- Category
- Hours
- Class Instruction
- 40
- Preparation
- 35
- Exam
- 35
- English
- 110
Kursusinformation
- Language
- English
- Course number
- SMIMA1161U
- ECTS
- 4 ECTS
- Programme level
- Part Time Master
- Duration
-
5 days
- Placement
- Autumn
- Price
-
Fees are published on the programme's homepage at https://mind.ku.dk/tuition/
Fee includes course materials and lunch/coffee.
Prices may be subject to change.
The textbook must be purchased by the participants.
- Schedulegroup
-
See course calendar
- Capacity
- 25 participants
- Studyboard
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinator
- Thomas Rades (12-796d74726678337766696a7845787a736933707a336970)
Teacher
Thomas Rades, Professor, Department of Pharmacy, Faculty of
Health and Medical Sciences, University of Copenhagen.
Hanne Mørck Nielsen, Professor at the Department of Pharmacy,
Faculty of Health and Medical Sciences, University of Copenhagen.
Anette Müllertz, Director of The Bioneer-FARMA Center, Department
of Pharmacy, Faculty of Health and Medical Sciences, University of
Copenhagen.
Heidi Lopez de Diego, Senior Specialist in solid state
characterization at H. Lundbeck A/S
Holger Grohganz, Associate Professor at the Department of Pharmacy,
Faculty of Health and Medical Sciences, University of Copenhagen.
Andrea Heinz, Associate Professor at the Department of Pharmacy,
Faculty of Health and Medical Sciences, University of Copenhagen.
The list of lecturers may be subject to change.
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