FARM2150 – Formulation of Drugs and Quality Assurance in Drug Production

Schedule, syllabus and examination date

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Course content

The course focuses on liquid and semi-solid formulations, such as solutions and dispersions. Reaction kinetics and 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, reaction kinetics, stability and shelf-life of pharmaceutical products.
  • 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 independently prepare preparation procedures, plan, 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 improve the final result.
  • 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

The course is only available to students enrolled at the Department of Pharmacy at the University of Oslo.

Prerequisites

Formal prerequisite knowledge

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 Program in Pharmacy.

For students admitted to the 5-year Master`s Program in Pharmacy until and including 2016 and who have been transferred from the old study plan, separate formal prerequisite knowledge apply. These are in professional compliance with the formal prerequisite knowledge that apply to the course, but may be replaced by courses from the old study plan, as well as transitional courses. Students on transitional arrangements may contact the study administration for å complete overview of the formal prerequisite knowledge required.

Recommended previous knowledge

Teaching

The course includes lectures, seminars, an educational excursion and laboratory work (“Flipped lab”):

  • 28 hours of lectures
  • 8 laboratory lectures (mandatory)
  • 58 hours of laboratory work (18 assignments and written reports) (mandatory)
  • 8 seminars
  • educational excursion to hospital pharmacy (3 hours)

Mandatory participation in the teaching must be completed and approved and mandatory submissions must be approved in order to be able to take the exam.

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.

Access to teaching

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, counts 30% of final grade
  • Written (digital) exam 4 hours, counts 70% of final grade

Both exams must be passed to pass the course.

For admission to the exam the following must be approved:

  • all laboratory work and laboratory lectures
  • 18  laboratory reports

Digital examination

The written examination is conducted in the digital examination system Inspera. You will need to familiarize yourself with the digital examination arrangements in Inspera.

Read more about written examinations using Inspera.

Examination support material

As of 1 August, 2016, the use of own calculators is no longer permitted. Casio FX-991EX calculators are handed out to all exam candidates at the beginning of the exam.

Language of examination

You may write your examination paper 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.

Explanations and appeals

Withdrawal from an examination

It is possible to take the exam up to 3 times. If you withdraw from the exam after the deadline or during the exam, this will be counted as an examination attempt.

Special examination arrangements

Application form, deadline and requirements for special examination arrangements.

Evaluation

The course is subject to continuous evaluation. At regular intervals we also ask students to participate in a more comprehensive evaluation.

Facts about this course

Credits

10

Level

Bachelor

Teaching

Every spring

Examination

Every spring

Teaching language

Norwegian