Pharmaceutics and Drug Development
Course content
Class lessons
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
characteristics of drug substances and biopharmaceutical aspects
influence their dosage form design. Several key topics will be
illustrated and reviewed using the specific drug products:
- Physicochemical properties of drug substances including solubility, log P, pKa, impurities and stability etc that influence the design of dosage forms
- Drug absorption, distribution, metabolism, and elimination
- Biopharmaceutical classification system
- 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 for various dosage forms
- Production techniques including the special regulations for sterile drug products
- Various 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.
Laboratory work
Lab exercises provide a practical opportunity to work on producing
solid, semi-solid, and liquid dosage forms, in which it is
possible to present a number of unit operations and evaluation of
the final drug 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.
Project assignment
Students work in a group consists of 4-5 students on one specific
drug molecule to deliver a literature project dealing with all the
important aspects in drug product development including
biopharmaceutics consideration, pre-formulation, formulation,
production and quality control for the specific drug
molecule.
MSc Programme in Pharmaceutical Sciences (English programme) - compulsory
MSc Programme in Medicinal Chemistry - elective
To give students a broad and solid knowledge in drug products and types of drug 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 product development in pharmaceutical industry. Laboratory work provides practical insight into pharmaceutical production techniques and evaluation methods that promote understanding of the core pharmaceutical sciences. Nomenclature and technical pharmaceutical terminology will also be introduced in the both class lessions and laboratory course.
At the end of the course, students are expected to be able to:
Knowledge
- Describe what the term medicine comprises
- Explain how dosage forms, drug properties, and administration routes affect the absorption, fate of drug substances in vivo related to bioavailability
- Explain formulation compositions of various pharmaceutical dosage forms
- Describe common manufacturing methods for various pharmaceutical dosage forms
- Describe quality assessment of drug substances, excipients, and drug products
- Describe the choice and use of various drug dosage forms for the various administration routes
- Explain critical characteristics of various dosage forms for drug substances
- Describe the general GMP requirements for producing drug products
Skills
- Discuss the influence of physicochemical properties of drug substances on the design of dosage forms
- Discuss the choice of excipients, manufacturing methods and equipment for various pharmaceutical dosage forms
- Discuss 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) for assessing the quality of final drug products
- 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.
- Discuss the challenges of developing new drug products
Competences
- Plan and design the formulation, production, and quality control of various pharmaceutical dosage forms for specific drug substances in question
- Discuss how physicochemical properties of drugs and excipients affect the formulation, manufacture and quality of drug products
•Laboratory work: 5 x 4 hours
•Class lessons: 24 hours
- Aulton’s Pharmaceutics, The Design and Manufacture of Medicines, M.E. Aulton Ed. 5th Edition 2017, Churchhill Livingstone
- Øvelsesvejledning/ Exercise Guide, Employees in Dept. A, 2009
Course teaching is based on the assumption that students have completed a bachelor's degree in the natural, health or technical sciences.
For students in the Danish Pharmacy program they must have passed ‘Organisk kemi I – fysisk kemiske egenskaber’ and ’Organisk kemi II – syntese af lægemiddelstoffer’. If you apply for the course as a credit transfer student, you must have passed both courses, or have obtained similar competencies from another course. Documentation for similar competences in the form of a course description and results after graduation must be attached to the application.
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
Credit transfer student at SUND – University of Copenhagen
(ku.dk)
Other external students:
https://healthsciences.ku.dk/education/student-mobility/guest-students/
Credit transfer and other external students are welcomed on the course if there are seats available and they have the academic qualifications.
- ECTS
- 2,5 ECTS
- Type of assessment
-
Requirement to attend classesOther
- Type of assessment details
- To obtain a course certificate, the student must have carried out all laboratory exercises, handed in all laboratory reports and had them approved.
- Aid
- All aids allowed
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
Criteria for exam assessment
The following elements must be demonstrated to obtain the course certificate:
Knowledge
- Describe formulation compositions and manufacturing methods for some solid, semi-solid and liquid dosage forms
- Describe relevant methods to evaluate the quality and stability of pharmaceutical preparations
- Describe the general GMP requirements for producing drug products
Skills
- Analyze the function of the ingredients used in pharmaceutical formulations
- Discuss the manufacturing methods, process control, and quality control on the pharmaceutical preparations
Competences
- Plan the production of some pharmaceutical preparations including solid, semi-solid and liquid dosage forms
- Plan relevant quality control methods to evaluate the pharmaceutical drug products
- Deliver satisfactory laboratory reports with critical review on the experimental data
- ECTS
- 5 ECTS
- Type of assessment
-
Written assignmentOral examination, 20 min
- Type of assessment details
- The individual oral examination is based on the literature
project report that the student wrote on drug product development
processes for a specific drug molecule in a group of ca. 4 - 5
students. The examination consists of up to 3 minutes of short
introduction to the report and ca. 15 minutes of questioning and
discussion. In the individual examination the student must be able
to clearly demonstrate that he or she has made an active
contribution in writing the report, and indicate the part that they
have contributed in the report.
Students in the same group cannot participate in their fellow students individual oral exam unless they have already had their own individual oral exam. - Aid
- All aids allowed
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
Criteria for exam assessment
In order to obtain the grade 12 the student must be able to:
Knowledge
- Explain how drug properties, administration routes, dosage forms influence bioavailability
- Describe the methods to characterize the physicochemical properties of drug substances
- Explain formulation compositions of various pharmaceutical dosage forms
- Describe common manufacturing methods for various pharmaceutical dosage forms
- Describe the quality assessment of drug substances and excipients
- Describe the choice and use of various drug dosage forms for the various administration routes
Skills
- Discuss the influence of physicochemical properties of drug substances on the design of dosage forms
- Discuss the choice of excipients, manufacturing methods and equipment for the design of various dosage forms
- Discuss pharmacopeia methods for assessing the quality of final drug products
Competences
- Plan and design the formulation, production, and quality control of various pharmaceutical dosage forms
- Discuss how physicochemical properties of drugs and excipients affect the formulation, manufacture and quality of drug products
Single subject courses (day)
- Category
- Hours
- Lectures
- 24
- Preparation
- 88
- Practical exercises
- 20
- Project work
- 48
- Exam
- 26
- English
- 206
Kursusinformation
- Language
- English
- Course number
- SMPS20004U
- ECTS
- See exam description
- Programme level
- Full Degree Master
- Duration
-
1 block
- Placement
- Block 2
- Schedulegroup
-
A And C
- Capacity
- 60 students (4 seats reserved for international students).
- Studyboard
- Study Board of Pharmaceutical Sciences
Contracting department
- Department of Pharmacy
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinator
- Mingshi Yang (12-726e736c786d6e337e66736c45787a736933707a336970)
Timetable
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