FA513: Pharmaceutical preformulation
Internal Course Code
Comment
Entry requirements
Academic preconditions
The scientific fundament of the course is the skills that the students have acquired from their chemical or pharmaceutical education. The course builds on basic competencies in chemistry and physical chemistry as well as elements from drug formulation and manufacturing.
Basic chemical background equal to KE501: Basic chemistry (10 ECTS), KE538: Physical Chemistry for pharmacy (5 ECTS) and KE505: Organic chemistry (10 ECTS) or similar.
Participant limit
Course introduction
Expected learning outcome
- Understand the pharmaceutical implications for the solid stage selection for the active substance
- In depth understand the pharmaceutical chemical studies that can be considered to support rational drug formulation work
- Understand and select the relevant pharmaceutical and physicochemical elements and considerations in the discovery phase, how this can be used to select the most suitable development candidate, as well as how to define a rational pharmaceutical formulation strategy
- Have a deep theoretical and application-oriented understanding of the chemical reactivation and stability of pharmaceutical substances so that stable formulations can be selected more quickly based on a chemical mechanistic understanding
- Have an insight into how the other topics discussed in the course should be viewed from a biopharmaceutical perspective and what this might mean for the definition of the pharmaceutical manufacturing process
Content
The course contains the following main areas;
- Pharmaceutical developability activities
- Determination of the solid phase including salts, cocrystals and polymers in a pharmaceutical context
- Determining the pharmaceutical formulation strategy
- Pharmaceutical compatibility studies
- Solubility theory and the related chemical characterizations
- Assessment of the chemical stability of active substance and drug formulation via chemical mechanistic understanding of the breakdown
- Setting up relevant phase diagrams for amorphous solid solutions and lipid based formulations
Literature
Examination regulations
Exam element a)
Timing
Tests
Portfolio
EKA
Assessment
Grading
Identification
Language
Examination aids
ECTS value
Additional information
- 80% participation in examiner hours
- Take-home assignment drawn up in groups of 2 people with a duration of 48 hours
- A oral examination in the content of the examiner lessons
- Take-home assignment drawn up in groups of two people/individually with duration of 48 hours
Indicative number of lessons
Teaching Method
Planned lessons:
Total number of planned lessons: 32
Hereof:
Common lessons in classroom/auditorium 32
The teaching consists of group lessons, where an introduction to the course's topics is given, an overview is created and perspective is given for both the individual opinion and the whole reviewed in the course. Dialogue is created using questions and built-in cases, but also by asking the students to hold parts of the introduction based on discussion of relevant primary literature.
The teaching also consists of discussion of cases in groups as well as in plenary sessions immediately following the lectures. Involvement is essential to ensure positive learning, and the students are encouraged to participate actively in the teaching as much as possible, for example by solving tasks in groups or other work in groups or independent work.
Other planned teaching activities:
- Reading the material
- Work in study groups, including the use of cooperative learning
- Preparation of exam assignment
The aim is for the students to work with the material in a different way than usual teaching. The self-study may be used as preparation for the teaching lessons or there may be work from the self-study that is directly reported in the teaching hours. Cooperative learning is envisaged as part of the self-study.