At the end of this practical work, students should be able to make magistral preparations in accordance with legal requirements, including capsules, suppositories, oral solutions & suspensions, eye drops & nasal drops and dermatological preparations. As drug specialists, they must also be able to know and understand the industrial manufacturing processes of the various pharmaceutical forms commonly dispensed in pharmacies and hospitals, such as capsules, naked tablets, coated tablets, pellets and injectable preparations. On the other hand, they also need to know how to control quantitatively and qualitatively these different dosage forms by means of tests commonly used as quality control tests such as pharmacotechnical tests (dissolution, hardness, friability), microbiological tests (sterility) and osmolarity or viscosity measurements described in the different pharmacopoeias.
- To be able to make magistral preparations in accordance with legal requirements. - To know and understand the industrial manufacturing processes of the different pharmaceutical forms commonly delivered to pharmacies and hospitals. - Know how to control these different dosage forms and the critical steps in their manufacture.
The content of the Practical Work in Galenic Pharmacy course (MPHAM211) is a continuation of the Master 1 Galenic Pharmacy courses (MPHAM114 and MPHAM115). The magistral preparations covered in Master 1 (gastroluble capsules / powder mixtures, suppositories, liquid preparations and simple dermatological preparations) will be reviewed and supplemented by new, more complex preparations (gastroresistant capsules, eye drops, nasal instillation preparations, more complicated dermatological and cosmetic preparations). These preparations may be accompanied by the students writing a practical report or completing a questionnaire designed to assess their understanding of the corresponding subject. These documents will include their observations, calculations, etc. Students will also be required to draw up a laboratory notebook, which they will be able to keep for personal use and complete during their pharmacy placement.
In addition, a calculation and reflection test will be organised every week in the laboratory.
Magistral preparations:
1) Preparations from the Therapeutic Magistral Formulary (TMF).
2) Complex preparations.
3) Cosmetic preparations (only available when conditions allow).
Practical work in the laboratory: after the dispensation of the good practice instructions (safety, use of the material) and during a period of one month, the students will have access to the laboratory where the galenic practical work will be carried out. This will be free teaching where students will be able to approach the preparations at their own pace with validation of their preparations by the supervisors. The tasks of those involved in this course are as follows: - Mentor: will provide theoretical support and answer specific questions from students (either face-to-face or via a question box on the webcampus); - Assistant: will ensure the smooth running of the practical sessions. The assistant will be available to the students during different periods of the day; - Technician: will ensure the supply of raw materials, the preparation of the laboratory at the beginning/end of the session and will check the cleanliness of the laboratory during the course. The technician will also be available to the students at various times during the day.
In addition to weekly tests and quizzes, students will sit a practical exam at the end of the month. At the end of the month's practical work in galenics, they will have to make two magistral preparations drawn at random, under the supervision of the assistant and/or supervisor. These preparations must comply with official standards (uniformity of content, uniformity of mass, sterility test, dissolution test, etc.) and must be accompanied by a laboratory report. A 3rd preparation must be discussed (not carried out) by the student.
Distribution of points:
Weekly exams: 25%
Preparations (including packaging, labelling and questionnaires): 25%
Practical exam: 50%
General comments and penalty points:
The weekly tests will always follow the same format, with the first question relating to a "rule of three". Any error on this question will result in an automatic mark of 0/20 for the assessment concerned, as well as a penalty of one point on the final mark for the UE.
The supervisory team attaches great importance to respect for laboratory equipment and staff, and to the prevention of chemical waste. Any behaviour that interferes with the smooth running of the practical work may result in a penalty.
We also attach great importance to safety and good laboratory practice. In the event of non-compliance with the BPDL or inappropriate behaviour, penalties (or even exclusion from the laboratory for the day) may be applied.
Each day, a laboratory supervisor will be appointed from among the students. This student will be responsible for the cleanliness of the shared equipment (balances, hoods, dissolution baths, etc.) and for tidying up and maintaining order in the laboratory.
Each student will be allocated an individual cupboard, which he or she will have to check every day (inventory provided by the laboratory technologist).
The laboratory notebook may be checked at random during practical sessions and at the examination. Failure to complete the notebook will result in a penalty.
In the event of a second session, a practical examination will be organised and only the mark from this assessment will count for the August session (no marks from tests, questionnaires, etc. will be carried over).
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| Training | Study programme | Block | Credits | Mandatory |
|---|---|---|---|---|
| Master in Pharmacy, Professional focus | Standard | 0 | 4 | |
| Master in Pharmacy, Research focus | Standard | 0 | 4 | |
| Master in Pharmacy, Research focus | Standard | 2 | 4 | |
| Master in Pharmacy, Professional focus | Standard | 2 | 4 |