EPN

FARB1400 Pharmaceutics and Drug Calculations Course description

Course name in Norwegian
Legemiddelfremstilling og legemiddelregning
Study programme
Bachelorstudium i farmasi - reseptarutdanning
Weight
10.0 ECTS
Year of study
2021/2022
Curriculum
SPRING 2022
Schedule
Course history

Introduction

This course covers the formulation and production of non-sterile pharmaceuticals. 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.

Required preliminary courses

The student must have been admitted to the study programme.

Learning outcomes

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

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 carry out correct drug calculations and can assess and control his/her own and other people’s calculations
  • 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

Content

Subjects covered by the course, with credits specified:

  • Drug calculations 1 credit
  • Pharmaceutics 9 credits

Teaching and learning methods

Work and teaching methods include lectures, seminars, study groups, project assignments, group work and skills training in the form of laboratory assignments.

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.

Course requirements

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 at laboratory courses

Assessment

Combined exam:

1) Supervised individual written exam in pharmaceutics, 3 hours

2) Individual practical exam in pharmaceutics, 3 hours 

3) Supervised individual written exam in drug calculations, 2 hours

One overall grade is awarded based on the following weighting of parts 1 and 2 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.

In addition, the student must pass the exam in drug calculations. A faultless exam paper is required to pass. If a student fails the drug calculations exam, he/she must retake this part.

Students can appeal the grade awarded for part 1 and 3 of the exam.

Permitted exam materials and equipment

All parts of the exam: Calculator

Grading scale

Parts 1 and 2 pharmaceutics: Grade scale A-F

Part 3 drug calculations: Pass/fail

Examiners

Parts 1 and 2 pharmaceutics: All exams are assessed by two examiners. At least 30% of the exam papers will be assessed by an external examiner. The external examiner’s assessment should benefit all the students.

Part 3 drug calculations: All the exam papers will be assessed by an internal examiner.

Overlapping courses

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