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 of Galenic Pharmacy (MPHAM211) is a continuation of the Galenic Pharmacy courses of Master 1 (MPHAM114 and MPHAM115). The magistral preparations covered in Master 1 (gastroluble capsules / mixtures of powders, suppositories, liquid preparations and simple dermatological preparations) will be reviewed and completed by new more complex preparations (gastroresistant capsules, eye drops, nasal instillation preparations, more complicated dermatological and cosmetic preparations). The realization of these preparations will be accompanied by the drafting of a report of TPs by the students. These reports will include their observations, calculations, etc... The students will also have to write a laboratory notebook that they can keep for personal use and complete during their pharmacy internship. In addition, a calculation and reflection test will be organised every week via the webcampus test tool. In parallel with the production of these magistral preparations, the students will have moments of reflection and discussion in small groups in order to dissect the industrial manufacturing processes of different pharmaceutical specialities marketed and presenting a particular galenic form. This work will also cover the quality control tests to be carried out during the manufacturing process to ensure that it runs smoothly (in-process controls) as well as the tests to be carried out on the finished product to ensure its conformity before release.
At the end of the practical galenic sessions (after one month of practical work), the students will have to make, in the presence of the assistant and/or the supervisor, three magistral and/or cosmetic preparations chosen at random. These preparations must comply with the official standards (uniformity of content, uniformity of mass, sterility test, dissolution test, etc.). They must be accompanied by a report identical to those requested during the previous month.
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