SLVKA0331U Pharmaceutics and Drug Development

Volume 2014/2015
Education
MSc in Pharmaceutical Sciences - compulsory, MSc 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

Formål / Objective

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.

Målbeskrivelse / Course outcome

At the end of the course, students are expected to be able to:
  • Describe what the term medicine comprises
  • Have knowledge of absorption, fate of drug substances in vivo related to bioavailability
  • Have aquired knowledge in different dosage forms
  • Have acquired insight into the challenges of developing new drug products
  • Be able to clarify the critical characteristics of various dosage forms for drug substances and rational design of dosage forms for specific drug substance in question
  • Have acquired knowledge of producing various dosage forms of drug substances
  • Have acquired knowledge of quality assurance and quality control for drug products
  • Have acquired knowledge of The Danish Medicine Agency’s requirements for drug approval
  • Have acquired knowledge about The European Pharmacopoeia (Ph.Eur.) and Danish drug standards (DLS)
  • Be able to choose suitable methods to characterise the biopharmaceutic and physicochemical properties of drug substances and characterize drug products
  • Have an insight into 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
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
Credit
7,5 ECTS
Type of assessment
Oral examination
Written assignment
Prøveform / Examination type:
Individual oral examination based on project and laboratory reports. All reports must be approved prior to examination.

Prøvedesign / Examination design
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

Beskrivelse af prøven og bedømmelse / Description of examination and assessment criteria

Beståkrav / Pass criteria

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.

Karakterbeskrivelse / Description of grades

12 - Excellent performance
The student must be able to:
  1. elucidate the principles for producing the most commonly used dosage forms of drugs by relevant, pharmaceutical unit operations
  2. elucidate the most commonly used methods and equipment for producing drugs
  3. elucidate the influence of the physical and physical-chemical properties of raw materials on drug production
  4. being able to discuss factors that influence the quality of end drug product
  5. elucidate the general GMP requirements for producing drugs
  6. elucidate pharmacopia methods for assessing the technical properties of drugs
7 - Good performance
The student must be able to:
  1. explain the principles for producing the most commonly used forms of drugs by relevant, pharmaceutical unit operations
  2. discuss the most commonly used methods and equipment for producing drugs
  3. relate the influence of the physical and physical-chemical peroperties of raw materials on drug production
  4. categorize the factors that influence drug quality
  5. sketch out the general GMP requirements for producing drugs
02 - Acceptable performance
The student must be able to:
  1. know the principles for producing the most commonly used forms of drugs by relevant, pharmaceutical unit operations
  2. know the most commonly used methods and equipment for producing drugs
  3. know the influence of the physical and physical-chemical properties of raw materials and drug production
  4. mention factors that have influence on drug quality
  5. know the general GMP requirements for drug prodcuction
  6. mention the pharmacopia methods for evaluating the technical properties of drugs.