FA502: Drug formulation and production A (5 ECTS)

STADS: 03000101

Level
Bachelor course

Teaching period
The course is offered in the autumn semester.

Teacher responsible
Email: kuntsche@sdu.dk

Timetable
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Comment:
Ekstraordinær F-time i FA502 fredag den 11/11 kl. 12-14 i U14.

Prerequisites:
None.

Academic preconditions:
Students taking the course are expected to:

• have knowledge about general and organic chemistry, physics and biology.
• have basic calculation skills (basic equations, calculation of concentrations, calculations with physical units etc.).
• have practical experiences of laboratory work and fundamental laboratory safety rules.
• be able to use common computer programs (e.g. word and excel).

Course introduction
The aim of the course is to introduce general aspects and requirements in drug formulation and production and to provide comprehensive knowledge about liquid and semi-solid formulations especially with regard to formulation principles and manufacturing methods together with the relevant physico-chemical principles, structure and functional properties of pharmaceutical excipients as well as definitions and requirements of the European Pharmacopoeia (Ph.Eur.) and the Danish Drug Standards (DLS).

The course provides the basis for the subsequent courses in pharmaceutical technology (FA 503 and FA 504). As an interdisciplinary discipline itself, the course illustrates the relevance of other courses in natural sciences such as physical chemistry, chemistry, analytical chemistry and biology for the pharmaceutical sciences.

The course builds on the knowledge and competences acquired in the first-year courses in natural sciences (chemistry, physics, mathematics and biology) and the fundamental analytical techniques which have been acquired in FA 501 (Pharmacy introductory course).

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

• to provide knowledge and understanding of general aspects and requirements in drug formulation and production namely of liquid and semi-solid formulations, relevant pharmaceutical excipients and physico-chemical principles.
• to obtain fundamental skills in drug manufacturing in small scale combined with documentation and to use relevant literature (Ph.Eur. and DLS) and databases for information search
• to give competences in critical discussion of liquid and semi-solid formulations with respect to both drug development (development of new formulations) and commercial medicines (information to patients, medical doctors and nurses).

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

• apply requirements and definitions of the European Pharmacopoeia (Ph.Eur.) with respect to liquid preparations for oral use and cutaneous application and semi-solid preparations for cutaneous application.
• discuss the different formulations (solutions, suspensions, emulsions, ointments, creams and gels), their formulation principles and stability.
• apply relevant physico-chemical terms and principles with respect to the formulations stated above.
• discuss the use of pharmaceutical excipients/excipient groups with respect to the formulations stated above.
• reason functions of pharmaceutical excipients in commercial medicines.
• apply and describe general biopharmaceutical terms and principles.
• manufacture relevant drug formulations (liquid and semi-solid formulations) in small batch-size together and to carry out adequate documentation.

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

• general definitions, requirements and principles in drug formulation and production (terms and definitions, quality assurance, stability, GMP)
• general biopharmaceutical aspects (administrations routes, LADME, bioavailability, general pharmacokinetic terms, bioequivalence)
• physiological and biopharmaceutical considerations concerning the oral and dermal administration route
• relevant monographs and requirements of the European Pharmacopoeia (Ph.Eur.) and the Danish Drug Standards (DLS)
• formulation principles and general production methods of liquid formulations for oral use and cutaneous administration
• formulation principles and general production methods of semi-solid formulations for cutaneous administration
• definitions and general production methods of herbal medicines
• relevant pharmaceutical excipients and groups of excipients (solvents and co-solvents, preservative agents, antioxidants, thickeners, stabilisers such as surface-active compounds, buffers) and their functional properties
• relevant physico-chemical principles of solutions (solubility and solubilisation, acid-base properties, colligative properties, pH, pKa, logP), suspensions, emulsions (disperse systems, stabilization and instability phenomena, electrostatic and steric stabilization, DLVO plot and zeta potential) and semi-solid formulations (ointments, creams and gels, incompatibilities, rheology)
• extemporaneous formulations (definitions and requirements) and preparation of drug formations in small scale incl. adequate documentation

Literature

• Churchill Livingstone Elsevier: Aulton’s Pharmaceutics.
• Europæisk Farmakopé (Ph.Eur.): Danske Lægemiddelstandarder (DLS).
• kursusmaterialer (lægges på e-learn).

Website
This course uses e-learn (blackboard).

Prerequisites for participating in the exam

1. Participation in tutorials and laboratory exercises is a prerequisite for taking part in the examination b). Pass/fail, internal evaluation by teacher.

Assessment and marking:

1. Home assignments and reports with acceptable replies for all assignments and reports. Pass/fail, internal evaluation by teacher (1 ECTS). (03000112).
2. 2 written tests (1 hour each) and a home assignment. Overall assessment, external censorship, Danish 7-mark scale At the written tests are only calculator, digital pen and hand scanner allowed. At the home assignment are all aids allowed apart from communicating with others (4 ECTS). (03000102).

Reexamination in the same exam period or immediately thereafter. The mode of reexamination may differ from the mode of the ordinary exam.

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: 22 hours
Skills training phase: 30 hours, hereof:
 - Tutorials: 6 hours
 - Laboratory exercises: 24 hours

Educational activities

Educational form
Activities during the study phase:

• self study of the textbook and other relevant literature
• homeworks and laboratory reports
• continuous collection and repetition of the learning materials and course contents

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.