Characterization of Drug Substances and Drug Delivery Systems

Course content

In the development of stable, safe and effective drug products, it is essential to understand the role and importance of preformulation and formulation activities and how to evaluate and select formulation strategies for solving pharmaceutical challenges.

Assessment of data obtained using relevant experimental methods/techniques for characterization of drug substances and the performance of drug delivery systems is crucial in various areas within pharmaceutical sciences.

Students interested in formulation design, drug delivery, analytical techniques, drug manufacturing, ADME and medicinal chemistry, will profit from attending the course.

The course will focus on interplay between the drug candidate physicochemical properties and drug-ability and discuss how solubility, lipophilicity, pKa, stability and solid state properties affect the in vivo fate as well as selection of formulation design strategies.

The course will cover selected drug delivery systems including properties and effect of relevant excipients, e.g. cyclodextrins, prodrugs and nanoparticulate systems. Emphasis will be on evaluation of drug delivery systems to optimize the bioperformance and not to give a comprehensive overview of various drug delivery systems.

The course will include separation-based, spectroscopic, thermal and microscopic methods, X-ray scattering techniques, titrations and dissolution/release methods for characterization of drug substances, excipients and drug delivery systems.

In the course, the students will apply their basic scientific knowledge and skills by working with selected pharmaceutical cases and assignments.

Education

MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and cand.scient.pharm) - elective

MSc Programme in Medicinal Chemistry - elective

MSc Programme in Pharmaceutical Sciences (English programme) - elective

Learning outcome

At the end of the course, the students should be able to:

Knowledge

  • define concepts and terms related to preformulation and formulation activities.
  • identify and discuss the importance of properties of drug substances and drug delivery systems in relation to development of effective drug products.
  • explain principles in experimental methods and techniques used for characterization of drug substances and drug delivery systems.
  • account for the advantages and limitations of methods used for characterization of drug substances and the performance drug delivery systems.

 

Skills

  • analyse and assess experimental obtained data for characterization drug substances and drug delivery systems.
  • discuss selection of drug candidates and design of delivery systems on the basis of their stability, solid state and physicochemical properties.
  • critical evaluate formulation strategies for solving pharmaceutical challenges based on scientific studies.
  • present and discuss aspects related to preformulation and formulation issues.

 

Competencies:

  • plan studies related to characterization of drug candidates and drug delivery systems for selection of formulation design strategy.
  • obtain further and specialized knowledge and skills related to preformulation and formulation aspects.

The course is structured to be based on student centered learning.
Each week will be related to specific topics and the students will work in groups of 4-5 on assignments after introduction lecture(s). The students will be given relevant materials and can consult a teacher at scheduled times. The solution/answer to the assignment will be discussed (and feedback given) with students from other groups by splitting the groups. In plenum for all students attending the course, selected students should orally present solutions/answers. Finally, the teacher will give lectures on the topics of the week. It is mandatory to participate actively in the group work and the discussion of the assignments and all students must present at least one time during the course. Concurrently with these activities, a project work based on a literature study with focus on a specific drug substance and selected drug delivery systems will be performed in the groups. The results of the project work should be presented in the form of a poster at a poster session for all students attending the course.

Selected scientific articles, chapters from relevant books and supplementary notes.

Teaching is based on the assumption that the students have acquired knowledge, skills and competences corresponding to those obtained by completion of the first five semesters of the BSc Programme in Pharmacy.

Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
ECTS
7,5 ECTS
Type of assessment
Continuous assessment
Course certificate
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

To pass the course, the students should actively participate in group work, discussion of the assignments, oral presentation of solutions/​answers to assignments and project work including preparation and presentation of poster. 

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

Knowledge

  • define concepts and terms related to preformulation and formulation activities.
  • identify and discuss the importance of properties of drug substances and drug delivery systems in relation to development of effective drug products.
  • explain principles in experimental methods and techniques used for characterization of drug substances and drug delivery systems.
  • account for the advantages and limitations of methods used for characterization of drug substances and the performance drug delivery systems.

 

Skills

  • analyse and assess experimentally obtained data for characterization drug substances and drug delivery systems.
  • discuss selection of drug candidates and design of delivery systems on the basis of their stability, solid state and physicochemical properties.
  • critical evaluate formulation strategies for solving pharmaceutical challenges based on scientific studies.
  • present and discuss aspects related to preformulation and formulation issues.

 

Competencies:

  • plan studies related to characterization of drug candidates and drug delivery systems for selection of formulation design strategy.
  • obtain further and specialized knowledge and skills related to preformulation and formulation aspects.

Single subject courses (day)

  • Category
  • Hours
  • Lectures
  • 23
  • Theory exercises
  • 42
  • Preparation
  • 70
  • Colloquia
  • 14
  • Project work
  • 54
  • Colloquia
  • 3
  • English
  • 206