Course syllabus

Läkemedelsformulering
Drug Formulation

KLGN35, 7,5 credits, A (Second Cycle)

Valid for: 2018/19
Decided by: PLED B/K
Date of Decision: 2018-03-21

General Information

Compulsory for: B4-l, K4-l
Elective for: N5-nbm
Language of instruction: The course will be given in English

Aim

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

Learning outcomes

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 quality 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.

Competences and skills
For a passing grade the student must

• be able to document their work according to the standard present in pharmaceutical industry
• be able to use and understand the terminology that are standard in the pharmaceutical industry
• be able to estimate what formulation that are suitable for different chemical compounds and therapeutic situations
• be able to present their work oraly
• 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.

Examination details

Grading scale: TH - (U,3,4,5) - (Fail, Three, Four, Five)
Assessment: Oral exam, active participation in case work and laborative work, written laboration reports according to industry standard. Written and oral presentation of a project. Fina grade is based on the oral exam.

The examiner, in consultation with Disability Support Services, may deviate from the regular form of examination in order to provide a permanently disabled student with a form of examination equivalent to that of a student without a disability.

Admission

Required prior knowledge: KFKF01, BLTF01/BLT115 or KETF30/KET030.
The number of participants is limited to: No
The course overlaps following course/s: KLG027

Reading list

• Aulton: Pharmaceutics, The Design and Manufacture of Medicines. Churchill Livingstone, ISBN: 0443101086/9780443101083.
• Distributed papers during the course.

Contact and other information

Course coordinator: Professor Marie Wahlgren, Marie.Wahlgren@food.lth.se
Course homepage: http://www.food.lth.se