Kursussøgning, efter- og videreuddannelse – Københavns Universitet

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Kursussøgning, efter- og videreuddannelse

Drug Formulation and Delivery

Practical information
Study year 2016/2017
Time
Autumn
Price

DKK 17,200, non EU/EEA citizens DKK 20,068. Fee includes course materials and meals.  Prices may be subject to change. The textbook must be purchased by the participants.

Programme level Part Time Master
ECTS 4 ECTS
Course responsibles
  • Thomas Rades (12-7b6f7674687a3579686b6c7a477a7c756b35727c356b72)
  • Korbinian Löbmann (18-7276796970757068753573766c6974687575477a7c756b35727c356b72)
  • Department of Pharmacy
Course number: SMIMA1161U

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 12 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.

Learning outcome

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”

Mandatory prerequisites

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

Sign up

Application deadline 1 September 2016.

Apply here

Education

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).

Studyboard

Study Board for Part-time Master’s Programmes of Pharmaceutical Sciences

Course type

Part time Master and Diploma courses

Teacher

Thomas Rades, Professor at the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen.
Jukka Rantanen, Professor at the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen.
Hanne Mørck Nielsen, Associate Professor at the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen.
Lassina Badolo, Principal Scientist / In Vitro Dx ADME at H. Lundbeck A/S
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
Daniel Bar-Shalom, Associate Professor at the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen.
Moein Moghimi, Professor at the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen.
Kyrre Thalberg, Ass. Principal Scientist at AstraZeneca, R&D, Lund
Marco van de Weert, Associate Professor at the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen.
Charlotte Vermehren, Managing Director at DermaVeris ApS

Duration

28 November - 2 December 2016

Schedulegroup

5 days
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Teaching and learning methods

Lectures, group work, student presentations, project report.

Capacity

25 participants

Language

English

Literature

Before the course, students should read chapters 1, 2, 8, 18, 19, 20, 21, 23, 24, 26, 27, 37, 39, 46, 50 in the textbook “Aulton's Pharmaceutics: The Design and Manufacture of Medicines" by M.E. Aulton and K.M.G. Taylor (eds.) (Churchill Livingstone; 4th edition, 2013).

A total of approx. 250 pages + hand-outs from course presentations.

Workload

Category Hours
Preparation 35
Class Instruction 40
Exam 35
English 110

Exam (SMIMA1161E)

Type of assessment

Written assignment
Essay on a selected case of drug formulation and delivery (8-15 pages, to be submitted 6 weeks after the course).

Marking scale

7-point grading scale

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.

Censorship form

External censorship

Exam period

Announced at the MIND programme's webpage

Re-exam

Announced at the MIND programme's webpage

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