SLVK18003U  Pharmaceutics and Drug Development

Volume 2019/2020
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 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.

Learning Outcome

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
  • 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, 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
Continuous feedback during the course of the semester
Credit
2,5 ECTS
Type of assessment
Course participation
Other
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 assesment

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
Credit
5 ECTS
Type of assessment
Written assignment
Oral examination, 20 min
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.
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

  • 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
  • Category
  • Hours
  • Lectures
  • 24
  • Preparation
  • 88
  • Practical exercises
  • 20
  • Project work
  • 48
  • Exam
  • 26
  • Total
  • 206