Research Project in Pharmaceutics and Drug Delivery

Course content

Problem-oriented and case-based teaching. Students work in groups of 3 to 4 on a research project dealing with selected aspects of pre-formulation, formulation and testing of types of drugs. Advisers provide students with a project topic and students are then expected to conduct independent literature studies, formulate the project together with the process adviser, conduct practical laboratory work, and practise making a presentation in a discussion class mid-way through the course. The project is concluded by a project report and subsequent individual oral examination.
The project starts with a planning phase, in which students define the project together with a process adviser on the basis of the project topic and self-selected background literature. Project topics may be defined together with a Danish company (we currently have contact with Lundbeck and Novo Nordisk) and represent a specific problem these companies would like investigated. Then students draft a research protocol, which includes choice of method, regard for the physical-chemical characteristics of the drugs and secondary substances, as well as statistical deliberations. The research protocol will be discussed with internal advisers as well as corporate advisers. Laboratory work will consist of pre-formulation studies, drug development and testing (if possible). Emphasis will be on the systematic testing and mechanical studies of secondary substances and formulation characteristics. Students will make ongoing laboratory portfolios to give them practice in process evaluation. Each student will report on the general course of the process and will contribute to group work.
A discussion class will be held mid-way through the course so that each project group can make an electronic presentation dealing with the project and its current status. The process adviser as well as corporate advisers will participate.
At the end of the course each group will write up a project report based on literature studies and research conducted. The report must contain relevant theories about drugs, secondary substances, types of drugs, indications, biopharmaceutical and pharmacological characteristics. The results found must be reported clearly and precisely in keeping with the conventions in force in English-language journals.

Education

MSc in Pharmaceutical Sciences - compulsory

Learning outcome

 

To introduce students to selected aspects of drug development and design as well as pre-clinical studies of the characteristics of secondary substances and formulations via a laboratory-based development project.

At the end of the course, students are expected to be able to:

Skills

  • Plan and conduct research concerning drug formulation with regard to physical-chemical and microbial stability, biopharmaceutical characteristics and technical production aspects
  • Draft and present written documentation of the work carried out in the form of laboratory portfolios and the project report.

 

Competences

  • Produce a pilot-scale drug formulation and conduct a pharmaceutical assessment of the type of drug in question by selecting relevant equipment and tests

Three lectures, 96 hours of laboratory work, 40 hours of discussion classes, etc. (for a total of 413 hours).

  • M.E.Aulton, Pharmaceutics, The Design and Manufacture of Medicines, 3. edition, Churchill Livingstone Elsevier 2007.
  • A.T. Florence and D. Attwood, Physicochemical Principles of Pharmacy, 4th edition, Pharmaceutical Press 2006.
  • Original research articles and review articles, research papers, selected by students.
  • Guidelines for the Research Project in Pharmaceutics and Drug Delivery (Department of Pharmaceutics and Analytical Chemistry, 2009), Torben Schæfer, Jørn Møller-Sonnergaard and Birger Brodin.

Course teaching is based on the assumption that students have taken the course entitled Pharmaceutics and Drug Development, and have acquired knowledge corresponding to the content of the subjects Pharmacology (general and organ-related), Organic Chemistry and Physical Chemistry.

ECTS
15 ECTS
Type of assessment
Course participation
Oral examination
Examination type:
The student is assessed on the basis of satisfactory participation in laboratory work and discussion classes, satisfactory effort in connection with designing the laboratory portfolio and written report, as well as on the basis of an oral examination on the project report.

Examination design:
At the end of the course students draw up a project report and turn it in to the adviser and external examiner. Then each student takes an oral exam, which consists of a 10-minute oral presentation of parts of the project report, followed by a 10-minute discussion of the contents of the report.
Aid
Written aids allowed

and approved pocket calculator.

Marking scale
7-point grading scale
Censorship form
External censorship
Criteria for exam assessment

A well-structured project report and a clearly and precisely formulated presentation. The student demonstrates a firm grasp of the research and topics covered in the project report. In the course of the project, the student has demonstrated serious commitment as well as the ability to cooperate with the rest of the group, and has taken the initiative in designing the tests, finding specialised literature and preparing the portfolios.

To achieve the grade 12 the student must be able to:

Knowledge

  • Understand important concepts and methods used to develop drug formulations
  • Explain general chemical, physical-chemical and pharmacokinetic characteristics of drug formulations
  • Assess the chemical and physical-chemical characteristics of the secondary substances used
  • Describe the role of secondary substances in drug formulations
  • Demonstrate which pharmaceutical assessments should be made of the drug formulations produced.

 

Skills

  • Plan and conduct research concerning drug formulation with regard to physical-chemical and microbial stability, biopharmaceutical characteristics and technical production aspects
  • Draft and present written documentation of the work carried out in the form of laboratory portfolios and the project report.

 

Competences

  • Produce a pilot-scale drug formulation and conduct a pharmaceutical assessment of the type of drug in question by selecting relevant equipment and tests
  • Category
  • Hours
  • Lectures
  • 3
  • Preparation
  • 274
  • Colloquia
  • 40
  • Practical exercises
  • 96
  • English
  • 413