FA501: Pharmacy introductory course (10 ECTS)

STADS: 03000001

Level
Bachelor course

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

Teacher responsible
Email: steffansen@sdu.dk

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

Prerequisites:
None

Academic preconditions:
None

Course introduction
The analytical part first introduces GLP (good laboratory practice) as well as general aims and methods of qualitative and quantitative drug analysis. The students get insight into the design of analytical methods as well as data interpretation to facilitate their ability to independently plan and perform quality testing of selected drug substances according to methods described in the European Pharmacopoeia. The biological part of the course provides a general introduction into pharmaceutically relevant organisms, such as plants, fungi, parasites and zoonoses.

Qualifications

• Expertise in using analytical instruments, preparation of stock solutions and dilutions as well as planning, performing and documentation of qualitative and quantitative analytical methods by, e.g.,  spectrophotometry and titration,
• Expertise in using selected analytical methods described in the European Pharmacopoeia and data interpretation,
• Expertise in investigation and identification of plants and herbal material,
• Expertise in the evaluation of taxonomic information, 
• Expertise in the assessment of biological aspects of herbal materials, fungi, parasites and zoonoses with special regard to drug development and their pathogenic potential.

Expected learning outcome
After introduction into drug analysis, the student is expected to be able to:

• operate analytical instruments such as balances, pH-meter, volumetric flasks, burettes,
• pipette accurately, incl. operation check and calibration, 
• independently plan and execute simple analytical laboratory exercises in consideration of laboratory safety rules and document results in a concisely written report,
• calculate concentrations and dilutions of stock solutions and dilution series, e.g. to establish and use a calibration curve,
• execute quantitative analysis of single compounds in solution by titration or spectrophotometry.

After the biological part, the student is expected to be able to:

• prepare single microscopic preparations of biological materials and to analyze them in an optical microscope,
• explain the overall biological taxonomy and its principle,
• identify herbs from selected lines and families,
• describe structure (anatomy and morphology) of organisms, organ functions and to identify different organs and tissues,
• describe the live cycle of selected plants, fungi, parasites and zoonoses.

After the analytical part (methods of the European Pharmacopoeia), the student is expected to:

• have theoretical knowledge about selected analytical methods,
• be able to explain principles of the above mentioned methods, their area of application and potential sources of error,
• be able to calculate the uncertainty of the above mentioned methods,
• be able to explain the requirements of the European Pharmacopoeia on accuracy and precision for the above mentioned methods and unit operations (e.g. determination of mass and volume),
• have obtained sufficient knowledge about analytical chemistry to facilitate independently an evaluation and execution of general and analytical issues concerning drug analysis,
• be able to prepare detailed instructions for selected volumetric and gravimetric analytical methods of the European Pharmacopoeia.

Subject overview
Introduction into drug analysis

• GLP (good laboratory practice)
• Calculation of concentrations (percentage, molar concentrations)
• Preparation of stock solutions, dilutions and buffer solutions
• Establishing and use of calibration curves
• Planning of experiments and documentation

Biology

• Biological taxonomy and systematics
• Morphology, anatomy, characteristic compounds and reproduction of plants with pharmaceutical relevance
• Biology of fungi as source of new drug compounds and pathogens
• Basic biology and live cycle of parasites and zoonoses

Drug analysis after methods of the European Pharmacopoeia

• Identity
• Purity
• Volumetric methods (acid-base-titrations, redox-titrations, precipitation-titrations, complexation-titrations)
• Gravimetric methods
• Spectrophotometric methods
• Chemical reactions and equilibrium

Literature

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

Website
This course uses e-learn (blackboard).

Prerequisites for participating in the exam
Participation in laboratory exercises i a prerequisite for participating in examination parts a, b, and c. Pass/fail, internal evaluation by teacher.

Assessment and marking:

1. Report on laboratory exercises. Pass/fail, internal evaluation. If the report is not approved, there will be a chance of a re-hand in. 1 ECTS
2. Mandatory assignments in plant biology. Pass/fail, internal evaluation. If the assignments are not approved, there will be a chance of a re-hand in. 2,5 ECTS
3. Mandatory assignments in pharmacopeia analytic part. Pass/fail, internal evaluation. If the assignements are not approved, there will be a chance of a re-hand in. 2,5 ECTS
4. 2 hours written exam without aids (based on examination parts a and c, and textbook "Introduction to pharmaceutical chemical analysis"). Evaluated by Danish 7-mark scale, external evaluation. 4 ECTS

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.

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

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.