Drug Formulation and Delivery

Course code: FMIMA1161U (previously A-8116)

Course objectives

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.

Target group

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

Prerequisites

Applicants must meet the following criteria:

• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

Learning outcomes

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 route of administration when designing a dosage form
• Summarise the main processes related to formulation design

Skills

• Identify relevant physicochemical properties of active pharmaceutical ingredients (APIs) and excipients as a part of formulation work
• Identify relevant biological aspects related to delivery route as a part of formulation work

Competencies

• Identify and extract relevant information from the overall drug development process
• Work in teams and exchange knowledge with other drug development professionals when implementing basic formulation design principles in practice

Contents

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.

Course materials/syllabus

Before the course, students should read chapters 1, 2, 8, 19, 20, 21, 22, 24, 25, 27, 36, 38, 41, 43 in the textbook “Aulton's Pharmaceutics: The Design and Manufacture of Medicines" by M.E. Aulton (ed.) (Churchill Livingstone; 3rd edition, 2007).

A total of 226 pages + hand-outs from course presentations.

Teaching methods

Lectures, group work, student presentations, project report.

Assessment

Type of examination: Essay on a selected case of drug formulation and delivery (8-15 pages, to be submitted 6 weeks after the course). Active participation in the course is a prerequisite.

Examiners: Course directors and an external examiner

Assessment: According to the 7-point grading scale

Grading

Grade 12:

The participant:

• 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.

Grade 7:

The participant:

• 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.

Grade 02:

The participant:

• 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.

Student workload

Preparation: 35 hours
Confrontation: 40 hours
Essay writing: 35 hours
A total of 110 hours

Course directors

Professor Jukka Rantanen, PhD, Department of Pharmaceutics and Analytical Chemistry, The Faculty of Pharmaceutical Sciences, University of Copenhagen.

Lecturers

The list of lectures is preliminary, yet to be confirmed.

• Jukka Rantanen, Department of Pharmaceutics and Analytical Chemistry, The Faculty of Pharmaceutical Sciences, University of Copenhagen.
• Hanne Mørck Nielsen, Department of Pharmaceutics and Analytical Chemistry, The Faculty of Pharmaceutical Sciences, University of Copenhagen.
• Lassina Badolo, Principal Scientist / In Vitro Dx ADME at H. Lundbeck A/S
• Anette Müllertz, Director of The Bioneer-FARMA Center, Department of Pharmaceutics and Analytical Chemistry, The Faculty of Pharmaceutical Sciences, University of Copenhagen
• Heidi Lopez de Diego, Senior Specialist in solid state characterization at H. Lundbeck A/S
• Daniel Bar-Shalom, Associate Professor at The Department of Pharmaceutics and Analytical Chemistry, The Faculty of Pharmaceutical Sciences, University of Copenhagen
• Moein Moghimi, Professor at The Department of Pharmaceutics and Analytical Chemistry, The Faculty of Pharmaceutical Sciences, University of Copenhagen,
• Kyrre Thalberg, Ass. Principal Scientist at AstraZeneca, R&D, Lund
• Marco van de Weert, Associate Professor at The Department of Pharmaceutics and Analytical Chemistry, The Faculty of Pharmaceutical Sciences, University of Copenhagen
• Charlotte Vermehren, Managing Director at DermaVeris ApS 

Practical information

Status: 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 at the Faculty of Pharmaceutical Sciences (subject to study board approval).

Date: 12-16 November 2012. Deadline for submission of report: 30 November 2012.

Application deadline: 3 September 2012. Application form

Course credits: 4 ECTS credits = a student workload of approx.110 hours

Course fee: Part-time master’s students at Faculty of Pharmaceutical Sciences DKK 12,630, freelance students DKK 14,960, non EU/EEA freelance students DKK 18,060. An additional fee of DKK 900  is charged for course materials and lunch. Prices may be subject to change. The textbook must be purchased by the participants.

Course capacity: 30 participants

Language of instruction: English

Preliminary course description