SLVKA0371U Pharmaceutics and Drug Development

Volume 2018/2019
Education

MSc Programme in Pharmaceutical Sciences (English programme) - compulsory

MSc Programme in Medicinal Chemistry - elective

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 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.

 

Laboratory work
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.
 

Project assignment
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.

Learning Outcome

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:

Knowledge

  • 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

 

Skills

  • 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.
Literature
  • 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
None.
Course teaching is based on the assumption that students have completed a bachelor's degree in the natural, health or technical sciences, and have passed at least 15 ECTS credits in chemistry, of which at least 10 ECTS credits must be in the field of organic chemistry.
•Laboratory work: 5 x 4 hours
•Class lessons: 24 hours
  • Category
  • Hours
  • Exam
  • 26
  • Lectures
  • 24
  • Practical exercises
  • 20
  • Preparation
  • 88
  • Project work
  • 48
  • Total
  • 206
Continuous feedback during the course of the semester
Credit
7,5 ECTS
Type of assessment
Oral examination, 20 min
The individual oral examination is based on the project report. The student must be able to clearly demonstrate at the examination that he or she has made an active contribution to writing the report.
Exam registration requirements

To qualify for the exam the student must have carried out all laboratory exercises, handed in all laboratory reports and had them approved.

In addition, the student must have handed in a project report written on a specific and detailed review of one or more forms of drugs and had the report approved.

Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
No external censorship
Criteria for exam assesment

In order to obtain the grade 12 the student must be able to:

Knowledge

  • 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

 

Skills

  • 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