FARM2150 – Formulation of Drugs and Quality Assurance in Drug Production
Course description
Schedule, syllabus and examination date
Course content
The course focuses on liquid and semi-solid formulations, such as solutions and dispersions. Evaluation of shelf-life are included. The course provides a thorough introduction to small-scale production of pharmaceutical products. Quality assurance in production of both sterile and non-sterile products constitutes an essential part of the course.
Learning outcome
After completing the course:
- you have a wide knowledge of the composition, stability and shelf-life of sterile and non-sterile semi-solid and liquid dosage forms.
- you have a wide knowledge of the principles of quality assurance and the significance of a quality assurance system in pharmaceutical production, together with knowledge on how the product quality is built into the finished product.
- you are able to follow current guidelines?independently prepare preparation procedures, plan, control, carry out and document the production of selected pharmaceutical preparations.
- you can handle unwanted occurrences in the production and evaluate how they will affect the quality of the finished product, and which measures that should be made to reduce the risk of recurrence.
- you have a reflected insight on the pharmacist’s responsibility in drug production.
- you can discuss pharmaceutical challenges linked to sterile and non-sterile semi-solid and liquid dosage forms.
Admission to the course
The course is only available to students enrolled at the Department of Pharmacy at the University of Oslo.
Formal prerequisite knowledge
Passed the exam in:
- FARM1100 – Pharmaceutical Chemistry
- FARM1110 – Pharmacology, Physiology and Cell Biology 1
- FARM1120 – Social Pharmacy
- FARM1130 – Pharmaceutically Based Organic Chemistry
- FARM1140 – Pharmacology, Physiology and Cell Biology 2
- FARM1150 – Pharmaceutical Based Biochemistry
- The compulsory HSE courses HMS0501 – Safety and Physical Environment, HMS0502 – Positive Learning Environment, HMS0503 – Laboratory Safety, HMS0506 – Patient Clinic Safety and HMS0507 – Fire Safety required for students at the 5-year Master`s Programme in Pharmacy.
The compulsory parts of:
- FARM2100 – Medicinal Chemistry
- FARM2110 – Pharmacotherapy 1
- FARM2120 – Pharmaceutics and Biopharmaceutics
Course exemption: Laws and regulations describing the overall learning outcome regulate the Pharmacy Programme. Exemptions are only granted if all learning outcomes in the course are covered.?
Exemption is only granted for FARM2150 – Formulation of Drugs and Quality Assurance in Drug Production if all of the overlapping courses are passed: FRM2020 – Production, Quality Control and Distribution of Medicinal products (discontinued), FRM2030 – Quality Assurance in Drug Production (discontinued) and FRM3010 – Formulation, Production, and Control of Sterile Pharmaceutical Preparations (discontinued).
Recommended previous knowledge
- FARM2100 – Medicinal Chemistry
- FARM2110 – Pharmacotherapy 1
- FARM2120 – Pharmaceutics and Biopharmaceutics
Overlapping courses
- 4 credits overlap with FRM2020 – Production, Quality Control and Distribution of Medicinal products (discontinued).
- 3 credits overlap with FRM2030 – Quality Assurance in Drug Production (discontinued).
- 3 credits overlap with FRM3010 – Formulation, Production, and Control of Sterile Pharmaceutical Preparations (discontinued).
Teaching
The course includes lectures, seminars and laboratory work ("Flipped lab"):
- 22?hours of lectures
- 46 hours of laboratory work (compulsory)
- 13 laboratory lectures of 2 hours?(compulsory)
- 3 seminars of 2 hours
Compulsory participation in the teaching must be completed and approved and compulsory submissions must be approved in order to be able to take the exam.
Read more about what applies in the event of absence from compulsory activities.
As?the?teaching involves laboratory and/or field work, you should consider taking out a separate travel and personal risk insurance. Read about your insurance cover as a student.
A student who has completed compulsory instruction and coursework and has had these approved, is not entitled to repeat that instruction and coursework. A student who has been admitted to a course, but who has not completed compulsory instruction and coursework or had these approved, is entitled to repeat that instruction and coursework, depending on available capacity.
Completed and approved compulsory instruction and coursework are valid for 3 years.
Examination
- Practical examination 3 hours, which counts 30% of final grade.
- Written exam 4 hours, which counts 70% of final grade.
Both exams must be passed to pass the course. Passed practical examination is valid for 2 years.
For admission to the exam the following must be approved:
- all laboratory work
- all laboratory reports
Examination support material
You will have access to a calculator in Inspera?during exam.
Language of examination
The examination text is given in Norwegian. You may submit your response in Norwegian, Swedish or Danish.
Grading scale
Grades are awarded on a scale from A to F, where A is the best grade and F?is a fail. Read more about the grading system.
Resit an examination
This course offers both postponed and resit of examination. Read more:
More about examinations at UiO
- Use of sources and citations
- Special exam arrangements due to individual needs
- Withdrawal from an exam
- Illness at exams / postponed exams
- Explanation of grades and appeals
- Resitting an exam
- Cheating/attempted cheating
You will find further guides and resources at the web page on examinations at UiO.