FA501: Pharmacy introductory course (10 ECTS)

STADS: 03001201

Level
Bachelor course

Teaching period
The course begins in the autumn semester and continues in the spring semester.

Teacher responsible
Email: steffansen@sdu.dk

Additional teachers
Dahlgren@biology.sdu.dk

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

Prerequisites:
None.

Academic preconditions:
None

Course introduction
The aim of the course, which is divided into an introduction to analytical chemistry part, a biological part and a pharmacopeia analysis part, is to enable the student to plan and accomplish basic analysis of drug substances/active pharmaceutical ingredients (APIs) as well as define and describe organisms of pharmaceutical relevance, including plants, fungi, and other organisms involved in human parasitism or zoonosis. Furthermore the aim is to enable the student to calculate compound concentrations and give an account of qualitative and quantitative methods described in a pharmacopeia monographs with primary focus on The European Pharmacopeia (Ph.Eur) This includes that the student enables to define analytical concepts and concepts used in Ph.Eur. monographs as well as accomplish analysis according to “good laboratory practice” (GLP). 

The course aims are important in regard to the student is given knowledge to use and competences to discuss analytical methods described in applicable pharmacopeia’s when they take part in interdisciplinary work situations where the focus is to develop, perform and/or documents analysis of drug formulations and/or drug substances. The course aims are also important for giving the student competences necessary in order to take part in work situations where assessment of the biology of plants and fungi may affect development of drug substances and/or be relevant for prevention of diseases caused by fungi or other parasites and zoonoses.

In relation to the competence profile of the degree it is the explicit focus of the course to:

• Give knowledge and understanding of concepts and principles in selected analytical methods described in pharmacopeia monographs
• Give knowledge and understanding of substances water solubility
• Give knowledge and understanding of the selected methods applicability and knowledge of potential errors related to these methods
• Give knowledge and understanding of GLP
• Give knowledge and understanding of plant identification among selected divisions and angiosperm families
• Give knowledge and understanding of organisms’ anatomy, physiology, reproduction and organ function 
• Give knowledge and understanding of the life cycles of selected plants, fungi, and other organisms involved in parasitism and zoonosis
• Give skills to handle analytical laboratory equipment such as analytical balance, volumetric flask, pH-meter, burette, UV-spectrophotometer, TPC plate ect.
• Give skills in GLP including to conduct laboratory notebook
• Give skills to suitable pipetting, including function check and calibration
• Give skills to calculate substance concentrations and dilution factors used to perform fx. stock solutions and standards that are used for drawing and application of standard curves
• Give skills to calculate the precision of the applied quantitative procedures
• Give skills to identify and determine concentrations of single compounds in solution by titration and by spectrophotometry
• Give skills to prepare a detailed protocol for simple volumetric and gravimetric methods according to the description in monographs from primarily Ph.Eur.
• Give skills to provide an account of the overall biological systematics and taxonomy and their underlying principles  
• Give skills to make simple microscopic preparations of biological material and examine the preparations in a light microscope.
• Give competences to discuss Ph. Eur’s requirements to accuracy and precision related to the applied procedures including the basic single operations (fx. weigh, and volumetric measure of the single operations)
• Give competences to independently plan and perform regular analytical laboratory experiments according to the laboratory security regulations and competences to document results according to the course guidelines in report writing 
• Give competences to discuss issues in relation to regular analysis of drug substances/drugs
• Give competences to assess whether biological aspects of plants and fungi can affect drug development and/or be relevant in regard to prevention of disease arising from fungi, other parasites or zoonotic diseases. 

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

• Define terms and substantiate principles and applications of the selected analytical methods described in pharmacopeia monographs.
• Define GLP.
• Identify and classify plants from selected divisions and families.
• Describe organism anatomy, organ functions, and reproduction, including identification of different organs and tissues
• Describe the life cycle of selected organism groups
• Apply and handle analytical laboratory equipment and prepare stock solutions, dilutions and stand solutions for fx calibration curves
• Give an account of planning, documentation, execution and reporting quantitative and qualitative compound analysis by spectrophotometry, titration and TLC.
• Calculate concentrations and dilution factors used in stock solutions, dilutions and standards fx for preparation and application of calibration curves and standard curves.
• Calculate and draw standard curves in Excel or similar program
• Calculate precision of the selected procedure.
• Investigate and identify plants and plant tissues
• Describe biological taxonomic information.
• Apply and give an account of the selected analytical methods described in the updated pharmacopeias
• Account for solubility of ionized compounds
• Discuss and assess biological aspects of plants and fungi as sources of drug substances and of diseases caused by fungi or other parasites and zoonoses
• Describe and discuss the analytical experiments according the course report writing guidelines

Subject overview
The following main topics are contained in the course:

• Basic compound analysis according to GLP
• Concentration calculation and application of correct units (percentage, molarity etc.)
• Preparation of stock solutions and dilutions of compounds as well as buffer solutions
• Basic aqueous solubility experiments
• Preparation of calibration curves
• Preparation of standard curves in Excel or similar program
• Planning and documentation of experiments
• Biological systematics and taxonomy
• Morphology and anatomy of plants
• The plant kingdom, pharmaceutically relevant plant families
• The biology of fungi, their importance in discovery of new drug compounds and their role in causing disease
• The basic biology and life cycles of other organisms involved in parasitism and zoonosis
• Identification analysis according to Ph. Eur. (identification)
• Test of purity analysis according to Ph. Eur. (Test)
• Quantitative analysis according to Ph. Eur. (Assay)
• Volumetric methods (acid/base titration; redox titration, complexometric titration
• Gravimetric methods
• Spectrophotometric methods
• Equations for chemical reaction and chemical equilibrium

Literature

• Hansen, Steen m.fl: Introduction to Pharmaceutical Chemical Analysis.

Website
This course uses e-learn (blackboard).

Prerequisites for participating in the exam

1. Participation in laboratory exercises during the autumn semester is a prerequisite for participating in examination parts a) and b).
2. Participation in laboratory exercises during the spring semester is a prerequisite for participating in examination c).

Both a) and b) are evaluated by pass/fail, internal marking by teacher.

Assessment and marking:

1. Mandatory reports on laboratory exercises. Pass/fail, internal evaluation. Autumn semester. (2,5 ECTS).
2. Mandatory assignments in plant biology. Pass/fail, internal evaluation. Autumn semester. (2,5 ECTS).
3. Mandatory assignments in pharmacopeia analytic part. Pass/fail, internal evaluation. Spring semester. (1 ECTS).
4. Written exam (based on examination parts a), b) and c), and textbook "Introduction to pharmaceutical chemical analysis"). Evaluated by Danish 7-mark scale, external evaluation. (4 ECTS). (03001202).

Two possible reexaminations in parts a), b), and c) in form of a re-hand-in. Reexamination in part d) in the same exam period or immediately thereafter.

A closer description of the exam rules will be posted under 'Course Information' on Blackboard.

Expected working hours
The teaching method is based on three phase model.
Intro phase: 21 hours
Skills training phase: 89 hours, hereof:
 - Tutorials: 19 hours
 - Laboratory exercises: 70 hours

Educational activities Study phase: 23 hours
Educational form
Activities during the study phase:

• Terminology training i Ph. Eur. Monography (role reading exercise)
• Calculation training (concentration, percentage, molarity, unites, standard addition) Standard curve in Excel
• Memory exercise by mindmapping in central analytical concepts such as units, precision and accuracy

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.