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's Programme in Drug Discovery and Development including basic knowledge in pharmaceutics.

Admitted to the Master's Programme in Drug Management 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 - search, compile and Written and orally present and critically review knowledge from a given problem

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.

Instruction

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

Assessment

Written examination takes place at the end of the course. To pass the course is required apart from passed examination (7,5 hp), passed results of practice (3 hp), passed results of other compulsory parts (4,5 hp). Possibility to supplement failed compulsory part can be given at the earliest at next course and only in case of a vacancy.

If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the University's disability coordinator.