The objective of this course is to train the student in galenic formulation in terms of composition, manufacture and evaluation of finished products meeting quality control according to the European Pharmacopoeia. It aims to familiarise the student with the formulation of pharmaceutical specialities and magistral/officinal preparations. This course is devoted to the study of the role of excipients related to industrial manufacturing processes and to the formulation of magistral and officinal preparations. The practical work (TP) associated with this teaching aims at allowing the student to integrate through personal laboratory work all the problems related to the formulation, the manufacturing and the control of pharmaceutical forms. Attention will also be drawn to the follow-up of Good Officinal Pharmaceutical Practice (GOPP).
see section "Learning outcomes".
The topics covered include: solid pharmaceutical forms for oral use, liquid pharmaceutical forms (solutions, syrups, eye drops,...), dispersed systems (suspensions, emulsions), semi-solid preparations (creams, milks, ointments, gels,...) as well as rectal, vaginal, pulmonary and oropharyngeal preparations. All the chapters of the theory course are classified by route of administration and organised as follows: - Anatomical and associated biopharmaceutical background; - Theoretical principles of the formulations concerned; - Excipients specific to the types of formulations concerned; - Preparation methods (pharmacist or industrial level and associated quality control); - Examples of medicines (pharmacy and/or hospital level).
Workshops: Written test (theory and/or exercises) before each workshop session. The preparations made for the practical sessions and the associated preparation reports will also be marked. A final test based on the preparation of an unknown formula will take place at the end of the practical sessions (out of session); Theory: an oral exam will be used to evaluate the students. If the number of students is too large, a MCQ or exercises allowing access to the oral exam if successful can be set up. Distribution of points: The final TP mark integrating the marks of the 4 written exams, the 4 reports and the final exam counts for 25% of the theory mark. In case of marks lower than 10/20, either for the practical or the theory, a second session examination will be organised under the same conditions. The exact modalities of the assessment are subject to change when the examination timetable is being drawn up, depending on practical constraints that the faculty administration may face, or in case of illness/force majeure/emergency with a placement, or because of the health situation related to the coronavirus.
-FTM - European Pharmacopoeia - Pharmaceutical Preformulation and Formulation, Mark Gibson, Interpharm Press, 2001. - The Design and Manufacture of Medecines, Aulton's Pharmaceutics, Third Edition, Michael E. Aulton, Churchill Livingstone, Elsevier, 2007. - Basic Fundamentals of Drug Delivery, Rakesh.K. Tekade. Academic Press Elsevier, 2019. - Pharmacie Galénique - Formulation et Technologie Pharmaceutique, P. Wehrle, Maloine Edition, 2007. - Encyclopedia of Pharmaceutical Sciences and Technology, Fourth Edition, Jones Swarbrick, CRC Press, Taylor & Francis Group, 2013.