General provisions

Substitutes and corresponds to 3FG301 or 3FG510, Extemporaneous Compounding of Drug Products.

Entry requirements

For search within: Bachelor of Science Programme in Pharmacy the student should have at least 120 credits including 60 credits pharmacy including programme course in pharmaceutics and pharmaceutical physical chemistry, 10.5 credits and have followed all earlier courses within the programme.

Admitted to the Master Programme in Drug Discovery and Development including basic knowledge in pharmaceutics.

Qualified to single subject course is student with a Bachelor of Science in Pharmacy including knowledge equivalent 60 credits pharmacy including basic education in pharmaceutics. Other education is tested individually. Knowledge in Swedish and English equivalent what that is required for basic eligibility to Swedish higher education on basic level.

Learning outcomes

The students should on completion of the course: - be able to account for dosage forms and properties especially for oral, cutaneous and rectal administration and sterilely/aseptic produced drugs for parental and ocular administration - be able to produce and assess extempore-produced drug and explain the function of included excipients - be able to explain and apply aseptic working technique at production of sterile extemporaneous drugs - be able to calculate shelf-life for extempore-produced drugs - be able to explain biopharmaceutical issues, stability aspects and technical properties of extempore-produced drugs - be able to explain quality assurance and Good Manufacturing Practice (GMP) within extemporaneous compounding of drugs - be able to account for radioactive drugs, their production, properties and usage

Content

Certain pharmaceutical working methods and technical unit operations, sterilisation technique. For extempore-produced drugs relevant physical systems, their properties and characterisation. Dosage forms and properties, especially regarding drug for oral, cutaneous and rectal administration and certain sterilely produced drugs for parental and ocular administration. Especially, biopharmaceutical issues, stability aspects and technical properties are treated. Production of extemporaneous drugs. In this connection is treated especially the importance of different presentation techniques and physico-chemical properties about included subjects. Study and control of extempore-produced drugs. Quality assurance and Good Manufacturing Practice (GMP). Orientation concerning radioactive drugs, their production, properties and usage. Written and oral presentation that intends to train the student's ability to search, compile, present and review knowledge from a given problem critically.

Instruction

The teaching is given in the form of lectures, seminars, laboratory sessions, study visit and practice. Compulsory parts of the course: Course introduction, laboratory sessions, certain seminars, study visits and practice.

Assessment

Examination takes place at the end of the course. To pass the course is required apart from passed examination (examination code), passed results of practice (examination code), passed results of other compulsory parts (examination code). Possibility to supplement failed compulsory part can be given at the earliest at next course and only in case of a vacancy. Each student has the right to in all six examinations i.e. one examination and five re-examinations.