FA504: Drug formulation and production C (5 ECTS)

STADS: 03000601

Level
Bachelor course

Teaching period
The course is offered in the autumn semester.

Teacher responsible
Email: cun@sdu.dk

Additional teachers
mmb@sdu.dk
steffansen@sdu.dk
kuntsche@sdu.dk

Timetable
Show entire timetable
Show personal time table for this course.

Prerequisites:
None

Academic preconditions:
Students taking the course are expected to:

• Have knowledge of liquid and solid dosage forms equivalent to knowledge obtained in FA502 and FA503
• Be able to use calculations and terms of dosage forms and administration way similar to knowledge obtained in FA502 and FA504.
• Have knowledge about experimental work, laboratory safety, presentation of experiments and data treatment.

Course introduction
The aim of the course is to enable the student to choose, formulate, manufacture and evaluate dosage forms, which is important in regard to the competence profile of the education and the expert role of the pharmacist within the formulation, manufacturing and usage of drugs.

The course builds on the knowledge acquired in the courses FA501, FA502 and FA503  and gives an academic basis for studying the topics in “drug delivery and transport systems” that is a mandatory course at the Master program in Pharmacy as well as the elective courses ”drug transporters in ADME”, ”advanced sterile drugs” and ”experimental methods”.

In relation to the competence profile of the bachelor education in Pharmacy the course explicit focus on:

• To give the student knowledge, skills and competences to participate actively in pharmaceutical development of drug substances and drug products in relation to how a drug substance is formulated, administered and evaluated considering the nature of the drug substance and the indication.
• To provides the student with knowledge, skills, and competences to participate in projects and project groups with other health care professionals about the formulation, manufactory and usage of drug substances and products.
• To provide the student with knowledge, skills and competences to formulate manufactory and evaluate non-solid dosage forms.
• Give the competence to formulate manufactory and evaluate non-solid drug product.
• Give skills to enable formulation, manufactory, and evaluation of drug formulations
• Give knowledge and understanding of absorption, bioavailability, stability, administrations routes, drug formulation, pre-formulation, methods and processes of pharmaceutical sterilization, requirements for storage, containers and labelling of drug substances or drug products. 

Expected learning outcome
The learning objectives of the course is that the student demonstrates the ability to:

• Calculate permeability as well as absolute and relative bioavailability and use this to discuss classifying drug substances into the biopharmaceutical classification system.
• Describe pharmaceutical preformulation and use this to formulate drug products
• Calculate absorption, drug release, and stability and to discuss the impact on the choice of dosage form and administration way
• Give an account of excipients for parenteral formulations and discuss the implications for formulation, drug release, and stability.
• Perform an experimental evaluation of drug products and discuss if they comply with current Ph. Eur. requirements
• Have skills and competences in making reports about obtained experimental data and batch quality control.
• Substantiate  physiological properties of different commonly used administration routes and the impact on formulation of parenteral drug products
• To give an account for different methods to describe and quantify if the drug product complies with requirements set by the authorities.
• Give a brief account for formulation of biological drug substances and vaccinines.
• Describe shelf-life of drug products and guidelines for stability testing of drug products in development.
• List requirements for labeling of drugs.

Subject overview
The course FA504 is divided into 3 themes:

1. Drug absorption, drug transport and bioavailability
2. Pharmaceutical preformulation
3. Advanced drug formulations and dosage form evaluation

The first theme is concerned with central concept such as absorption, absolute and relative bioavailability, flux and permeability, as well as the biopharmaceutical classification system.

Theme 2 contains central element within physicochemical pharmacy with elements such as pK_a, partitioning coefficients, stability and shelf life.

The third theme concerns the different aqueous and semisolid dosage forms and their administration ways, as well as their formulation, manufacturing and evaluation.

Literature

• Aulton’s Pharmaceutics, 4. Edition.
• Ph.Eur and FDA guidelines.
• Larsen and Bundgaard: Arch Pharm Chemi Sci, Ed. 5, 66-86, 1997.
• Takeru Higuchi: Journal of Pharmaceutical Sciences, Vol. 50 (10), p874-875, 1961.

Website
This course uses e-learn (blackboard).

Prerequisites for participating in the exam

1. Participation in all lab exercises is a prerequisite for taking part in the exam (both a and b). Pass/fail, internal marking by teacher. (03000622)

Assessment and marking:

1. Reports on laboratory exercises. Exam aids allowed. Pass/fail, internal marking by teacher. (1 ECTS). (03000612).
2. Written exam (2 hours). Exam aids allowed. Danish 7-mark scale, external marking. (4 ECTS). (03000602). 

Expected working hours
The teaching method is based on three phase model.
Intro phase: 20 hours
Skills training phase: 22 hours, hereof:
 - Tutorials: 6 hours
 - Laboratory exercises: 16 hours

Educational activities

Educational form
Activities during the study phase:

• To prepare and submit reports based on work performed during the laboratory exercises.
• To study the curriculum of the course independently
• To work on assignments

Language
This course is taught in Danish or English, depending on the lecturer.

Course enrollment
See deadline of enrolment.

Tuition fees for single courses
See fees for single courses.