Pharmaceutics

Level of Study

Master

Place of Instruction

Department of clinical Science, University of Bergen

Objectives and Content

The course has 3 main focus areas.

Drug formulation:

The aim is to provide an understanding of drug production, particularly prescription production / small scale, with special focus on liquid and semi-solid systems. The course includes drug administration routes, physicochemical aspects of drug formulation and dosage, as well as considerations regarding their preparation including stability assessment. Students will be introduced to the practical aspects of producing liquid and semi-solid drug formulations, and will demonstrate competence in the safe and professional production of such dosage forms, including the design of worksheets and good documentation practice. The course also includes an introduction to pharmaceutical forms for veterinary use.

Sterile production:

The aim is to provide an introduction to production methods, technology and quality systems that are used in the production of pharmaceutical forms with requirements for sterility. The course also provides knowledge about the production and treatment with radioactive drugs.

Fixed dosage forms and drug technology:

The aim is to give students a broad understanding of conventional pharmaceutical technology. The main focus is the formulation and production of oral, solid pharmaceutical forms and other conventional forms of administration, the science behind these, production and packaging technology, as well as bioavailability / biopharmaceutical properties. Students get an introduction to the practical aspect of the development, production and quality control of oral, solid drug forms. The course also includes an introduction to requirements for stability testing for marketed drugs.

Learning Outcomes

After completion of the course in Pharmaceutical Formulation students should be able to:

KNOWLEDGE

The student

¿ Can describe the most important administration routes of drugs for patients

¿ Can describe the mechanisms surrounding oral absorption of drugs, including metabolism and how it varies between different dosage forms

¿ Can describe the physico-chemical principles behind rational formulation of liquid and semi-solid pharmaceutical forms

¿ Can describe the physico-chemical principles that underlie the design of oral, solid drug forms

¿ Can describe the production process used to produce various oral, solid pharmaceutical forms on a large and small scale.

¿ Can describe the physico-chemical principles behind the design of an aerosol form of administration

¿ Can describe the requirements for pharmaceutical packaging and packaging material

¿ Can describe the principles of production of sterile pharmaceutical forms and explain why quality assurance and validation of critical steps in the production process are particularly important

¿ Has knowledge of how requisitioning and use of veterinary medicines can contribute to ensuring good animal health and food safety

¿ Has advanced knowledge of quality requirements, assurance and control of key steps in the development, production, storage and distribution of drugs, cf. requirements for QP and FFA

SKILLS

The student

¿ Can master the production of key liquid and semi-solid pharmaceutical forms

¿ Can master the production of key solid dosage forms

¿ Can discuss the basic principles for the manufacture of sterile drugs

¿ Can independently prepare production regulations according to current guidelines, and plan, control, execute and document the production of selected pharmaceutical preparations

¿ Can analyse formulation data and associated analysis results to work independently with practical and theoretical drug formulation

¿ Can master quality assurance, quality control and documentation, for production of liquid and semi-solid drugs on a small scale, related to prescription production

¿ Can master quality assurance, analytical quality control and documentation, for production of solid, dosed drugs on a small scale

¿ Can use monographs in the current pharmacopoeia (Ph Eur) to test product performance

¿ Can use an active substance's physicochemical data to formulate oral medicine

¿ Can interpret recognized reference sources and use stability data to assess stability and compatibility of pharmaceutical product

¿ Can discuss the basic principles for the preparation and treatment of radioactive drugs, including the clinical use of these.

¿ Can carry out the development of quality systems for medicines, drug handling and drug-related products and services

GENERAL COMPETENCE

The student

¿ Has insight into and understanding of drug production, including various dosage forms

¿ Use reputable reference sources to plan the production of pharmaceutical forms in a quality that is suitable for patient use

¿ Can explain the concept and importance behind product performance testing, and the ability to interpret such data.

¿ Has insight into and understanding of how quality systems and quality and improvement work, in drug production contribute to safe drug use and increased patient safety

Required Previous Knowledge

FARM250, FARM280, FARM211

Access to the Course

The subject is reserved for students enrolled in the integrated master programme for Pharmacy

Teaching Methods and Extent of Organized Teaching

Lectures, workshops and digital modules in Mitt UiB and laboratory courses corresponding to 20 ECTS.

It is total three weeks of laboratory course, including exercises in drug formulations, sterile production and drug technology.

Compulsory Assignments and Attendance

Submission of laboratory reports. Participation and attendance in all practicals and workshops are compulsory. Students must pass all lab practicals to pass the course.

All mandatory activities must be passed in order to sit for the exam.

Forms of Assessment

Written exam, 6 hours

No aid allowed

Examination Support Material

Simple calculator, model is subject to limitations determined by UiB.

Grading Scale

A - F

Course Evaluation

The Students will evaluate the education in line with the University of Bergen and department Quality control systems.

Department

Department of Clinical Science