Aim
The aim of this course is to give, based on basic knowledget of chemistry and chemical engineering, a depend understanding of formulation and production of pharmaceutical.

Knowledge and understanding
For a passing grade the student must

• be able to design different pharmaceutical formulations, including choice of ingredients, quality aspects and production methods.

• be able to evaluate how pharmaceutical components are taken up by the body

• have knowledge about the qulity system used in pharmaceutical industry

• understand how to characterise a pharmaceutical product including physical characterisation and in vitro release

• understand issues related to development of pharmaceutical products and be able to design a stability investigation.

Skills and abilities
For a passing grade the student must

• the students should be able to document their work according to the standard present in pharmaceutical industry

• the students should be able to use and understand the terminology that are standard in the pharmaceutical industry

• the students should be able to estimate what formulation that are suitable for different chemical compounds and therapeutic situations

• the student should be able to present their work oraly

• the student should be able to independently plan and execute laborative work

Judgement and approach
For a passing grade the student must

• comprehend the correlation between patient compliance and the choice of pharmaceutical product to develop.

• comprehend why there are such hard quality demands on the pharmaceutical industry and to understand the ethical demands that involved in pharmaceutical development.

Contents
The course describes pharmaceutical products and production with an emphasis on physicochemical and chemical engineering questions. It also describes what happens to the drug product in the living organism when administered through different routes. The course focuses on different pharmaceutrical formulations such as solutions, suspensions, emulsions, granulates, tablets, capsules, aerosols, creams etc.

Furthermore the course will give an overview of the quality aspects of pharmaceutical industry, and special requirements on pharmaceutical industry when it comes to demands from authorities both Swedish and international. The course will include visits to pharmaceutical industries and exercies that aim to show different aspects of pharmaceutical technology. The laboratory assignments will illustrate important formulation aspects and how to evaluate quality and physical chemical properties of the formulation. Furhtermore they will illustrate different quality documents in the industry.

Literature
Aulton: Pharmaceutics, 3 rd edition. The Design and Manufacture of Medicines. Churchill Livingstone. Published September 2007 SBN 0443101086/9780443101083.
Material that can be bought from the person responsible for the course.