FRM5520 – Advanced Drug Formulation, Production and Quality Control

Schedule, syllabus and examination date

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Course content

The course is to provide the students with insight into the formulation and production processes of tablets: the preformulation phase, the small scale production, and scale-up. The production process involves many types of processes, such as spray-drying, granulations/pelletization, compression and coating.
The students are led through the various steps in the process by having to solve relevant tasks aided by simple experiments. The main focus for the formulation problems will be (the lack of) powder flow and controlled release.

Preformulation: The central issues will be studies concerning the stability of the active agents, as well as characterizing physical and chemical properties. Spectroscopic methods such as UV/VIS and fluorescence will be employed in addition to DSC.

Lab formulation: The objective is a formulation that fulfils the desired powder flow, release rate, and technical quality. The methods used are the evaluation of powder flow, spray-drying (of lactose), granulations/pelletization, working with SOP, the production of trial batches, and the coating of tablets/pellets. In addition, the following will also be taught: Evaluation of hardness, friability, uniformity of mass etc, as well as the characterization of release rate by mathematical models.
Scale-up This will be illustrated through visits to industrial production sites.

The course syllabus is a collection of relevant literature (books, scientific articles) in order to provide the students with a thorough understanding of the problems connected to the formulation and production of pharmaceutical materials on a large scale.

Learning outcome

At the end of the course, the participants will, as part of a drug formulation team, be able to take responsibility for reformulation of pharmaceutical preparations.

Admission

The course is primarily open to students who have been admitted to the School of Pharmacy at the University of Oslo. If there is space available then others may also apply to take the course as long as their academic background is adequate.

Prerequisites

Formal prerequisite knowledge

The course is only available to students who have passed their pharmacy apprenticeship and have passed all previous pharmacy courses or have the equivalent academic background.

Recommended previous knowledge

Overlapping courses

10 credits overlap with FRM9520

Teaching

Study groups, a laboratory course, excursions and self-tuition.

The course is taught in 1 or 2 groups, each including between 4 to 7 students. The number of participants is limited to between 4 and 14.

Inactivity and / or excessive absences in compulsory education means that the student does not receive final assessment / examination

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.

Examination

A four hour written exam/oral exam after the number of students

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.

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

Resit an examination

This course offers both postponed and resit of examination. Read more:

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

Master

Teaching

Every autumn

Examination

Every autumn

Teaching language

Norwegian