SLVKA0331U Pharmaceutics and Drug Development
MSc in Pharmaceutical Sciences - compulsory
MSc in Medicinal Chemistry - elective
The students will be introduced to biopharmaceutical principles of drug delivery, scientific principles of dosage form design, pharmaceutical manufacturing technologies and different types of dosage forms. Teaching can be based on specific drug products, particularly the most widely used drug products. Selected drug products can be presented as 'hands on' examples, and special emphasis will be placed on how the special phsiochemical and biopharmacological characteristics of the drug substances influence their dosage form design. Several key topics will be illustrated and reviewed using the specific drug products:
- Requirements for drug substances including solubility, impurities and stability
- Quality requirements for drug products
- Quality assessment of drug substances, excipients and drug products
- Formulation and composition of drug products with regards to technical production requirements as well as bioavailability
- Selecting excipients
- Production techniques including the special regulations for sterile drug products
- Alternative administrative routes
- Drug product specifications and Pharmacopoeia requirements
- Quantitative and analytical techniques for drug substances and characterization techniques for physical characteristics of intermediate drug product and final drug products
- Process control and finished-products control
- Durability and stability studies
- Quality by Design (QbD) in Drug Development.
Lab exercises provide a practical opportunity to work on producing granulates and tablets, in which it is possible to present a number of unit operations and evaluation of the final drugs products. Pharmacopoeia monographs, GMP rules and other guidelines will also be briefly introduced during drug manufacturing lab exercises. In order to clarify the primary physicochemical and biopharmaceutic characteristics of the drug substances and their impact on the finished formulations, a number of pre-formulation assessment methods will be reviewed and demonstrated as part of the exercises.
Students work in groups of 4-5 students on a project dealing with all the important aspects of formulation, production and biopharmaceutical characteristics based on one or more specified forms of drugs.
To give students a broad and solid knowledge in drugs and types of drugs, with special focus on their formulation, production and quality assurance with respect to the appropriate regulatory requirements (Ph.Eur.). Further, to give an insight into drug development in pharmaceutical industry. Laboratory work provides practical insight into pharmaceutical production techniques and evaluation methods that promote understanding of core pharmaceutical sciences. Nomenclature and technical pharmaceutical terminology will also be introduced in the laboratory course.
At the end of the course, students are expected to be able to:
- Describe what the term medicine comprises
- Show knowledge of absorption, fate of drug substances in vivo related to bioavailability
- Show aquired knowledge in different dosage forms
- discuss the challenges of developing new drug products
- Clarify the critical characteristics of various dosage forms for drug substances and rational design of dosage forms for specific drug substance in question
- Produce various dosage forms of drug substances
- Debate quality assurance and quality control for drug products
- Discuss The Danish Medicine Agency’s requirements for drug approval
- Discuss The European Pharmacopoeia (Ph.Eur.) and Danish drug standards (DLS)
- Choose suitable methods to characterise the biopharmaceutic and physicochemical properties of drug substances and characterize drug products
- Identify the difference in drug development of small molecules and biologics.
- Aulton’s Pharmaceutics, The Design and Manufacture of Medicines, M.E. Aulton Ed. 3rd Edition 2007, Churchhill Livingstone
- Øvelsesvejledning/ Exercise Guide, Employees in Dept. A, 2009
•Class lessons: 24 hours
- Practical exercises
- Project work
Open for Danish and international guest students. For application details look here: http://sund.ku.dk/uddannelse/andre-uddannelsestilbud/meritstuderende/.
- 7,5 ECTS
- Type of assessment
- Oral examinationWritten assignmentIndividual oral examination based on project and laboratory reports. All reports must be approved prior to examination.
The basis for the individual oral examination is the series of reports written on a specific and detailed review of one or more forms of drugs.
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
Criteria for exam assesment
The basis for passing the course is having carried out all laboratory exercises, handed in all laboratory reports and had them approved. In addition, the project report must be satisfactory and the student must be able to clearly demonstrate at the examination that he or she has made an active contribution to writing the report.
In order to obtain the grade 12 the student must be able to:
- elucidate the principles for producing the most commonly used dosage forms of drugs by relevant, pharmaceutical unit operations
- elucidate the most commonly used methods and equipment for producing drugs
- elucidate the general GMP requirements for producing drugs
- elucidate pharmacopia methods for assessing the technical properties of drugs
- Discuss factors that influence the quality of end drug product
- Argue the influence of the physical and physical-chemical properties of raw materials on drug production