SMIMA1161U Drug Formulation and Delivery

Volume 2014/2015
Education

Please note this is course description is for the study year 2014/2015. For updated information on dates, prices etc. in other semesters please visit www.mind.ku.dk.

This course is a compulsory course at the Master's Programme in Industrial Drug Development.


The course is continuing professional development (CPD) intended for professionals who are working within drug development and manufacturing related activities.

Master’s level (second cycle higher education). Open for freelance students who meet the admission criteria. Compulsory for MIND students, elective for other part-time master's students. (subject to study board approval).

Content

The ultimate aim of drug formulation is to deliver the active pharmaceutical ingredient (API) through biological membranes to the right target in the right concentration during a defined time interval. Optimal performance of the drug formulation can be achieved by considering the physicochemical properties of API and excipients, along with both the pharmacological properties and processability of a given formulation. Understanding the most relevant factors affecting the drug product performance enables the development of an optimal pharmaceutical product.

 

The course will consist of 12 lectures covering different concepts related to designing a dosage form and delivering the active pharmaceutical ingredient to the right target. Lectures will cover the importance of biological and metabolic barriers related to delivery, role of preformulation/processing, and finally, the design of formulation –specific lectures will be on solid dosage forms, semisolids, inhalation products, and macromolecular delivery systems. Students will also work in small groups around given problems and summarize their problem as a presentation for other students. During the group work, students will learn how to effectively use different literature databases.

 

Learning Outcome

Upon completion of the course, participants are expected to be able to:

Knowledge

  • Demonstrate a basic knowledge about the relevant formulation strategies in connection with the route of administration when designing a dosage form
  • Demonstrate a basic knowledge about the specific advantages and disadvantages of the different routes of drug administration
  • Demonstrate a basic knowledge about the most important physicochemical properties of drugs and dosage forms underpinning the relevant formulation strategies
  • Demonstrate a basic knowledge about the most important groups and types of excipients used in the formulation of dosage forms
  • Demonstrate a basic knowledge about the most important biological and metabolic barriers related to delivery
  • Demonstrate a basic knowledge about role of preformulation and processing in drug formulation and delivery
  • Summarise the main processes related to formulation design.

Skills

  • To choose core formulation parameters in a formulation design, based on identification of relevant physicochemical properties of active pharmaceutical ingredients (APIs)
  • To choose core formulation parameters in a formulation design, based on identification of relevant physicochemical properties of excipients
  • To choose core formulation parameters in a formulation design, based on identification of relevant physiological aspects related to delivery route.

Competencies

  • Identify and extract the relevant information for a given drug formulation and delivery process, with respect to drug properties, excipient properties, and formulation technology.
  • Work in teams and exchange knowledge with other drug development professionals when implementing basic formulation design principles in practice”

Before the course, students should read chapters 1, 2, 8, 18, 19, 20, 21, 23, 24, 26, 27, 37, 39, 46, 50 in the textbook “Aulton's Pharmaceutics: The Design and Manufacture of Medicines" by M.E. Aulton and K.M.G. Taylor (eds.) (Churchill Livingstone; 4th edition, 2013).

A total of approx. 250 pages + hand-outs from course presentations.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
Lectures, group work, student presentations, project report.
  • Category
  • Hours
  • Class Instruction
  • 40
  • Exam
  • 35
  • Preparation
  • 35
  • Total
  • 110
Credit
4 ECTS
Type of assessment
Written assignment
Essay on a selected case of drug formulation and delivery (8-15 pages, to be submitted 6 weeks after the course).
Exam registration requirements

Active participation in the course is a prerequisite.

Marking scale
7-point grading scale
Censorship form
External censorship
Criteria for exam assesment

The grade 12 is given when the examinee:

  • has written a report in his/hers own words, which demonstrates an exhaustive literature search and the most important literature relevant for the selected case has been properly referenced
  • has demonstrated an ability to analyze, recapitulate and critically evaluate the most important literature for the selected case
  • has demonstrated a correct use of the terms and concepts used in the field of drug formulation and delivery
  • is able to critically evaluate the route of administration and dosage form design for an existing formulation presented in group work
  • is able to present relevant alternatives to this existing formulation.

The grade 7 is given when the examinee:

  • has written a report in his/hers own words, which demonstrates a thorough literature search and the important literature relevant for the selected case has been properly referenced
  • has demonstrated an ability to analyze and recapitulate the relevant literature for the selected case
  • has demonstrated a fairly correct use of the terms and concepts used in the field of drug formulation and delivery
  • is able to evaluate the route of administration and dosage form design with an existing formulation presented in group work
  • is able to present a relevant alternative to this existing formulation.

The grade 02 is given when the examinee:

  • has written a report in his/hers own words, which demonstrates a satisfactory literature search and some important literature relevant for the selected case has been referenced
  • has demonstrated an ability to understand and report relevant literature for the selected case
  • has demonstrated knowledge of the terms and concepts used in the field of drug formulation and delivery
  • is able to describe the route of administration and dosage form design with an existing formulation presented in group work
  • is able to describe a basic idea of an alternative to this existing formulation.