SFKKA9081U Pharmaceutical Preformulation - Profiling Drug Substances for the Biomedical Sciences
MSc in Pharmaceutical Sciences - elective, MSc in Medicinal Chemistry - elective, Cand.Scient.Pharm. - elective, Cand.Pharm. - elective
The course focuses on preformulation activities in drug discovery and in the drug development phase with emphasis on a practical approach. Experimental methods and data related to physical chemical characterization and stability studies of drug substances are presented and discussed. The following subjects are covered:
Solid state properties and characterization
- polymorphism, amorphous/crystalline forms, solvates
- experimental methods such as X-ray diffraction, DSC and TGA
Aqueous solubility
- pH-solubility profiles, salt selection, intrinsic dissolution rate
- solubility enhancing methods
- experimental measurements
- prediction
pKa
- experimental methods
- prediction
Partitioning
- pH-distribution profiles, extra thermodynamic relationships,
- experimental and calculation methods
Kinetics and chemical reactivity
- types of chemical reactions
- simple and complicated rate equations
- pH-rate profiles
- prodrugs
Stability testing
- planning stability tests
- temperature accelerated degradation
- solid state stability including drug-excipient compatibility
- experimental methods
Case studies and project work are used as the basis for discussing the application of the knowledge of physicochemical and stability properties of substances for selecting drug candidates and designing dosage forms . Further, the course is designed with emphasis on providing practical skills related to prediction and calculation of basic preformulation parameters.
The objectives of the course are to give students:
- insight into the methods used for physicochemical characterization of drug substances and instability studies as well as interpretation and assessment of experimental data.
- understanding of the importance of pharmaceutical profiling of
drug substances in relation to selecting formulation strategies and
drug administration route.
At the end of the course students should be able to:
Knowledge
- define concepts and terms related to preformulation.
- identify and discuss the importance of basic physicochemical and stability properties of drug substances in drug development.
- account for the advantages and limitations of methods used in pharmaceutical profiling of drug substances.
Skills
- calculate/predict basic prefomulation parameters.
- assess experimental data obtained in preformulation studies.
- discuss the selection of drug candidates and design of dosage forms on the basis of their stability and measured physicochemical properties.
- present and discuss preformulation issues in the form of a poster.
Competencies:
- design experiments related to physicochemical characterization and stability studies of drug substances.
- obtain further and specialized knowledge and skills related to preformulation.
Selected scientific articles, chapters from relevant books and supplementary notes.
•Student activities (project work, poster preparation, theoretical exercises, case studies, discussion of scientific articles, oral presentations): 18 hours
•Excursion: 3 hours
- Category
- Hours
- Exam
- 3
- Excursions
- 3
- Lectures
- 26
- Practical exercises
- 18
- Preparation
- 156
- Total
- 206
Open for Danish and international guest students. For application details look here: http://sund.ku.dk/uddannelse/andre-uddannelsestilbud/meritstuderende/.
- Credit
- 7,5 ECTS
- Type of assessment
- Oral examination, 15-20 minIndividual oral examination based on the project work. A short presentation (7 min) followed by discussion.
- Exam registration requirements
Prerequisites for taking the oral examination are (i) approval of four written reports with solutions to exercises and (ii) a poster prepared as the final product of a project work on a specific drug substance. The project work and the written reports are performed in groups of 2-3 students.
- Aid
- All aids allowed
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
Criteria for exam assesment
To pass the course the student must be able to:
Knowledge
- define concepts and terms related to preformulation.
- identify and discuss the importance of basic physicochemical and stability properties of drug substances in drug development.
- account for the advantages and limitations of methods used in pharmaceutical profiling of drug substances.
Skills
- calculate/predict basic prefomulation parameters.
- assess experimental data obtained in preformulation studies.
- discuss the selection of drug candidates and design of dosage forms on the basis of their stability and measured physicochemical properties.
- present and discuss preformulation issues in the form of a poster.
Competencies:
- design experiments related to physicochemical characterization and stability studies of drug substances.
- obtain further and specialized knowledge and skills related to preformulation.
Course information
- Language
- English
- Course code
- SFKKA9081U
- Credit
- 7,5 ECTS
- Level
- Full Degree MasterFull Degree Master choice
- Duration
- 1 block
- Placement
- Block 2
- Schedule
- B
- Course capacity
- 30
- Study board
- Study Board of Pharmaceutical Sciences
Contracting department
- Department of Pharmacy
Course responsibles
- Susan Weng Larsen (12-7678766471316f64757668714376787167316e7831676e)