General provisions

The course is a part of "European Master's degree program left Advanced Safety Sciences left Medicines designed by SafeSciMET as part of the European Innovative Medicines Initiative (IMI)"

Entry requirements

Bachelor's degree within chemistry or biology and basic courses in physical chemistry and physiology or the equivalent which be tested individually.

Learning outcomes

The students should on completion of the course:

- be able to account for the different routes of drug administration including prerequisites for drug absorption

- be able to account for the different dosage forms, included excipients and their function

- be able to account for manufacturing processes for the most common dosage forms

- be able to account for packaging and administration tool for drugs

- be able to explain relationship between the design of drug compounding, administration routes and the effect of the drug

- be able to account for quality assurance and Good Manufacturing Practice (GMP) in connection with drug production

- be able to search, compile, present and critically review knowledge from a given problem

Content

The course comprises:

Administration routes

The different dosage forms

For dosage forms relevant physical systems, their properties and characterisation

Preformulation i.e. initial characterisation of physico-chemical properties of active pharmaceutical substance

Drug Formulation with special emphasis how the properties of raw materials and design of the manufacturing process influence the technical and biopharmaceutical properties of drugs

Unit operations and production procedures

Stability of drug including stability testing

Packaging and administration tools

Quality systems and Good Manufacturing Practice (GMP)

Formulation aspects at laboratory animal studies

Instruction

Teaching is given in the form of lectures, demonstrations and project work.

Compulsory parts of the course:

All part in connection with demonstrations and project work.

Assessment

Written examination is arranged during the course. For passed in the course are required apart from passed test passed compulsory parts.

Each student has the opportunity to in all six examinations i.e. one examination and five re-examinations.