FARB1400 Pharmaceutics and Drug Calculations Course description

This course covers the formulation and production of non-sterile pharmaceuticals, and drug calculations. Important topics include pharmaceutical development, the study of types of pharmaceuticals and their composition, and production with pertaining quality control systems at different levels of production. The course provides a detailed introduction to practical production of non-sterile pharmaceuticals on a small scale, in which quality assurance in the production of pharmaceuticals is central.

The student must have been admitted to the study programme.

After completing the course, the student should have the following learning outcomes defined in terms of knowledge, skills and general competence:

Knowledge

The student

• can explain the composition and production of mixtures, ointments, creams, gels, capsules, granulates and tablets in accordance with basic principles, and their stability and durability
• can explain the physical properties of colloids and disperse systems
• can explain physical and/or chemical factors that can influence solubility, rates of dissolubility and sedimentation
• can explain requirements related to quality, quality assurance and control of pharmaceuticals and relevant medical equipment
• can describe which physical-chemical properties of active ingredients and additives in a formulation are important in the preclinical work of the pharmaceutics process
• can explain the key concepts in drug calculations

Skills

The student

• masters relevant techniques for the production of non-sterile pharmaceuticals
• can use relevant pharmaceutical reference works and apply academic knowledge to suggest solutions to theoretical and practical challenges related to the production of non-sterile pharmaceuticals
• can independently create production regulations, plan, control, implement and document the production of selected pharmaceutical specimens in accordance with the relevant guidelines
• can independently perform drug calculations correctly and assess and review his/her own and other’s calculations, as part of responsible professional medicines management
• can apply quality assurance systems and assess and handle unwanted incidents during production and the measures that must be implemented to reduce the risk of repeat incidents

General competence

The student

• has insight into and an understanding of the role and responsibility of pharmacists in connection with the production of pharmaceuticals
• can discuss challenges related to pharmaceutical formulation and production without being subject to sterility requirements
• can assess possibilities for individual adaptation of pharmaceutical formulation to create the best possible health at the individual level
• has insight into and an understanding of how quality systems in pharmaceutics and quality and preparatory work contribute to increasing patient safety

Work and teaching methods include lectures, seminars, study groups, project assignments and skills training in the form of laboratory assignments and workshops on drug calculations.

The flipped classroom method is used for parts of the course. Digital learning resources will be made available to students in advance, and the time they spend at the university will be used to work on assignments and group work.

The laboratory assignments elucidate physical-chemical principles and provide practical training in the pharmaceutics. A practical mock exam will be held at which the students are given individual feedback.

The following must have been approved in order for the student to take the exam:

• Minimum of 80% attendance at seminars
• Minimum of 90% attendance in skills training

Combined exam:

1) Supervised individual written exam in drug calculations, 3 hours

2) Supervised individual written exam in pharmaceutics, 4 hours

3) Individual practical exam in pharmaceutics, 3 hours

A faultless exam paper is required to pass the exam in drug calculations. If a student fails the drug calculations exam, he/she must retake this part. One overall grade is awarded based on the following weighting of parts 2 and 3 of the exam: Written exam in pharmaceutics 60%, practical exam in pharmaceutics 40%. Students must be awarded a pass grade (A-E) for both parts of the exam in pharmaceutics in order to pass the course. If the student is awarded an F in one part of the exam, this part of the exam must be retaken.

Students can appeal the grade awarded for part 1 and 2 of the exam.

All parts of the exam: Calculator

Part 1 drug calculations: Pass/fail

Parts 2 and 3 pharmaceutics: Grade scale A-F

Part 1 drug calculations and part 2 pharmaceutics: All answers are assessed by one examiner. An external examiner is used regularly, at a minimum of every third completion of the course. When selecting answers for external evaluation, a minimum of 10 percent of the answers shall be included, with no fewer than 5 answers. The external examiner’s assessment of the selected answers shall benefit all students.

Part 3 pharmaceutics: All answers are assessed by two examiners. An external examiner is used regularly, at a minimum of every third completion of the course. When selecting answers for external evaluation, a minimum of 10 percent of the answers shall be included, with no fewer than 5 answers. The external examiner’s assessment of the selected answers shall benefit all students.

• 9 credits overlap with the course FARMA1410 Pharmaceutical Technology.
• 1 credit overlaps with the course FARMA2400 Drug Calculations