SLVKA0341U Research Project in Pharmaceutics and Drug Delivery

Volume 2013/2014
Education
MSc in Pharmaceutical Sciences - compulsory
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.
Learning Outcome

Formål / Objective

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.

Målbeskrivelse / Course outcome

At the end of the course, students are expected to be able to:
  1. Plan and conduct research concerning drug formulation with regard to physical-chemical and microbial stability, biopharmaceutical characteristics and technical production aspects
  2. Produce a pilot-scale drug formulation and conduct a pharmaceutical assessment of the type of drug in question by selecting relevant equipment and tests
  3. Draft and present written documentation of the work carried out in the form of laboratory portfolios and the project report.
Literature
  • 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.
Three lectures, 96 hours of laboratory work, 40 hours of discussion classes, etc. (for a total of 413 hours)
  • Category
  • Hours
  • Colloquia
  • 40
  • Lectures
  • 3
  • Practical exercises
  • 96
  • Preparation
  • 274
  • Total
  • 413
Credit
15 ECTS
Type of assessment
Course participation
Oral examination
Prøveform / 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.

Prøvedesign / 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
All written and approved pocket calculator
Marking scale
7-point grading scale
Censorship form
External censorship
Criteria for exam assesment

Beskrivelse af prøven og bedømmelse / Description of examination and assessment criteria

Karakterbeskrivelse / Description of grades

12 - Excellent performance
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. The student demonstrates, with few minor weaknesses:
  • Command of important concepts and methods used to develop drug formulations
  • Command of explaining general chemical, physical-chemical and pharmacokinetic characteristics of drug formulations
  • Command of assessing the chemical and physical-chemical characteristics of the secondary substances used and command of understanding the role of secondary substances in drug formulations
  • Command of explaining which pharmaceutical assessments should be made of the drug formulations produced.
7 - Good performance
A structured project report and a reasonably well-formulated presentation. The student demonstrates a grasp of the research and topics covered in the project report. In the course of the project, the student has demonstrated the commitment and ability to cooperate with the rest of the group, and has taken initiative in designing the tests, finding specialised literature and preparing the portfolios. The student demonstrates, with minor weaknesses:
  • Understanding of important concepts and methods used to develop drug formulations
  • Ability to explain general chemical, physical-chemical and pharmacokinetic characteristics of drug formulations
  • Ability to assess the chemical and physical-chemical characteristics of the secondary substances used and command of understanding the role of secondary substances in drug formulations
  • Ability to explain which pharmaceutical assessments should be made of the drug formulations produced.
02 - Acceptable performance
A somewhat structured project report and presentation, although with some unclear and imprecise formulations. The student does not demonstrate a full grasp of the research and topics covered in the project report. In the course of the project, the student has not demonstrated commitment and ability to cooperate with the rest of the group, nor convincingly taken initiative in designing the tests, finding specialised literature and preparing the portfolios. The student is able to demonstrate:
  • Acceptable understanding of important concepts and methods used to develop drug formulations
  • Acceptable ability to explain general chemical, physical-chemical and pharmacokinetic characteristics of drug formulations
  • Acceptable ability to assess the chemical and physical-chemical characteristics of the secondary substances used and command of understanding the role of secondary substances in drug formulations
  • Acceptable ability to explain which pharmaceutical assessments should be made of the drug formulations produced.