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 physicochemical and biopharmaceutical characteristics of the drug substances influence their dosage form design. Several key topics will be illustrated and reviewed using some specific drug products:
- Biopharmaceutical classification.
- Requirements for drug substances including solubility, hydrophilic/hydrophobic property and stability.
- Quality requirements and assessment for drug products.
- Formulation design and composition of drug products with regards to technical production requirements as well as bioavailability.
- Selecting pharmaceutical 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.
- Stability studies and shelf-life.
- Quality by Design (QbD) in Drug Development.
Lab exercises provide a practical opportunity to work on producing semi-solid dosage forms and tablets, in which it is possible to practise 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 biopharmaceutical 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/group on a project dealing with all the important aspects of rationales of dosage form design, formulation, manufacturing and evaluation of final products based on one or more specified drugs.
To give students a broad and solid knowledge in pharmaceutical products, 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 acquired knowledge in physicochemical properties of drug substances that influence drug absorption and dosage form design.
- Show acquired knowledge in biopharmaceutical aspects that influence the fate of drug substances in vivo related to bioavailability.
- Show acquired knowledge in most commonly used dosage forms, and general GMP requirements.
- State the difference in drug development of small molecules and biologics.
- Choose suitable methods to characterise the biopharmaceutical and physicochemical properties of drug substances.
- Choose some relevant pharmaceutical excipients for formulating, and select relevant methods for manufacturing of the final drug product for a given drug substance.
- Produce relevant dosage forms of drug substances and evaluate final drug products according to The European Pharmacopoeia (Ph.Eur.).
- Debate quality assurance and quality control for drug products.
- Discuss the critical characteristics of various dosage forms for drug substances and rational design of dosage forms for specific drug substance in question.
- Identify the challenges in developing new drug products.
- Aulton’s Pharmaceutics, The Design and Manufacture of Medicines, M.E. Aulton Ed. 4th Edition 2013, Churchhill Livingstone
- Øvelsesvejledning/ Exercise Guide, Employees in Dept. A, 2009
•Class lessons: 24 hours
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 examination, 20 minThe individual oral examination is based on the project report written on a specific and detailed review of one or more forms of drugs. All laboratory reports must be approved prior to examination. The length of the oral examination is 20 min/student, and the students are allowed to bring any aids to the examination.
- 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.
Students will be assessed based on:
The physicochemical properties of drug substances. that influence drug absorption, dosage form design and drug production.
The biopharmaceutical aspects that influence the fate of drug substances in vivo related to bioavailability.
Most commonly used dosage forms, and general GMP requirements.
Suggest suitable methods to characterise the biopharmaceutical and physicochemical properties of drug substances.
Suggest relevant pharmaceutical excipients for formulating, and select relevant methods for manufacturing of the final drug product for a given drug substance.
Elucidate the principles for producing relevant dosage forms of a given drug substance using relevant pharmaceutical unit operations.
Evaluate final drug products according to The European Pharmacopoeia (Ph.Eur.).
Discuss factors that influence the quality of final drug products.
Identify the challenges in developing new drug products.
- Practical exercises
- Project work