The subject consists of 2 main parts: 1) Pharmaceutical formulation and 2) Pharmaceutical technology. The aim for part 1 is to give an understanding of pharmaceutical production, with particular focus on how liquid and semi-solid preparations are developed and manufactured. The subject includes routes of administration, physio-chemical aspects of pharmaceutical formulation and dosing, and considerations of the pharmaceutical production process. Students will be introduced to the practical aspects of production through laboratory work in production of liquid and semi-solid pharmaceutical formulations, and should resultantly demonstrate competence in manufacture of such dosage forms.

The goals for the second part of the course are to give students a broad understanding of conventional pharmaceutical technology. The main focus is on the formulation and production of oral, solid pharmaceuticals and other conventional administration forms, the science behind these, production- and packaging technology, in addition to evaluation of stability. The subject also gives knowledge on the production, manufacture and handling of radioactive pharmaceuticals. Students will be given an introduction into the practical aspects around production and quality control of oral, solid pharmaceutical dosage forms.

Sterile pharmaceutical production: An introduction will be given in production methods, technology and quality systems which will be used in the production of pharmaceutical where sterility is a demand.

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

• Describe the most important administration routes of pharmaceuticals to patients.
• Describe the mechanisms of oral absorption of drugs.
• Describe the physiochemical properties of rational formulation of liquid and semi-solid dosage forms.
• Interpret formulation data and subsequent analysis data towards choice of the most relevant formulations.
• Explain the therapeutic use of liquid and semi-solid drugs.
• Draft suitable production techniques, including quality assurance, quality control and documentation, for the production of liquid and semi-solid dosage forms in small scale.
• Produce pharmaceutical formulations from known reference sources in a quality that is suitable for patient use.

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

• Describe the physiochemical principles behind the design of oral, solid pharmaceuticals.
• Describe the small and large scale production processes used to manufacture different oral, solid pharmaceuticals
• Interpret a drugs physiochemical data and from this design the optimal oral formulation for the drug in solid form.
• Describe the physiochemical principles behind the design of aerosol administration forms
• Explain the concept and importance of testing of product performance, and the ability to interpret such data.
• Describe the demands of pharmaceutical packaging and packaging materials.
• Describe criteria of stability testing of pharmaceutical products, and ability to interpret stability data.
• Describe the fundamental principles of manufacturing and handling of radioactive pharmaceuticals, including the clinical applications of these.
• Describe the principles of sterile production and explain why quality assurance and validation of critical steps in the production process are of particular importance.

Pharmaceutical Technology:

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

Pharmaceutical Formulation:

the students must demonstrate competencies in the small-scale production of liquid and semi-solid pharmaceuticals. All lab practicals are compulsory and must be passed before the written exam can be taken.

Pharmaceutical Formulation

• Written Exam (3 hours)

Pharmaceutical Technology

• Written Exam (3 hours )

The final grade for the course FARM295 will be an average grade derived from results of the written exams in Pharmaceutical Formulation and Pharmaceutical Technology.