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Galenic Pharmacy and Pharmaceutical Technology

Code 13676
Year 4
Semester A1
ECTS Credits 16
Workload PL(30H)/T(30H)/TP(60H)
Scientific area Ciências Farmacêuticas
Entry requirements not appllicable
Mode of delivery Face-to-face
Work placements Not applicable.
Learning outcomes The generic aims are: 1. To promote the study of scientific and technological aspects of medicines for human use, including the different dosage forms, substances for pharmaceutical use, production methods, drug release/delivery technologies, control assays, packaging and labeling; 2. To develop laboratory competences in the development, production and quality control of drug products, with special focus on compounded formulations. The student should acquire the ability to: 1. use of the Pharmacopeias and the “Formulário Galénico Português” to execute preparations and tests; 2. distinguish, select, execute e justify the multiple operating procedures and good practices in pharmaceutical compounding; 3. Distinguish, enumerate, describe, classify, compare and justify excipients, dosage forms, technologies of drug release/delivery, procedures, tests, packaging, labeling and storage in the development and manufacturing of medicines.
Syllabus 1. Fundamental concepts and introduction to pharmaceutical compounding, solid preparations (introduction and powders), solid dispersions preparations for inhalation;
2. Granulates, tablets and capsules; modified release oral systems,
3. introduction to liquid dosage forms: rheology, simple and extractive solutions , derivate preparations; auricular preparations; Medicated chewing gums, oromucosal preparations
4. Colloidal dispersions, suspensions, and emulsions, nanomedicines and targeted delivery; nasal preparations
5. Cutaneous semi-solid preparations, transdermal therapeutic systems, nail lacquers, rectal and vaginal preparations, sticks; sterility and isotonicity, ophthalmic preparations
6. Parenteric preparations, preparations for irrigation, and recipients; stability of drug substances and products, pre-formulation studies, drug development for special populations.
Main Bibliography Nogueira Prista et al. 2011. TECNOLOGIA FARMACÊUTICA. 8ª/7a ed. Vol. I e II. FCG; Aulton, Michael E., and Kevin Taylor, eds. 2013. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. 4th ed. Edinburgh: Churchill Livingstone/Elsevier; Farmacopeia Portuguesa 8ª e 9ª ed., Infarmed, 2005/2008; Formulário Galénico Português, ANF e LEF; Allen, L.V. et al. 2007. Formas farmacêuticas e sistemas de libertação de fármacos. 8a Ed. Artmed Dec.-Lei n.º 176/2006 (Estatuto do Medicamento) e outros documentos legais; http://www.infarmed.pt/ ; ICH Topic Q 1 A (R2) Stability Testing of New Drug Substances and Products. 2006; SCIENTIFIC ARTICLES.
Teaching Methodologies and Assessment Criteria 1. Magistral lectures 2. Classes in groups of 20 to 28 students, for tutorial work, and resolution of exercises 3. Laboratory lectures in groups of 12-18 students, including preparation, control, packaging, labeling and documenting of manipulated medicines, , and control tests on pharmaceutical preparations, which serve to acquire technical skills and for application of knowledge .
The evaluation consists of: Assessment of theoretical knowledge (8 periodic assessment tests with a coefficient of 0.0625 each + 2 tests of integrated assessment with a weighting coefficient of 0.1 each) + 2 moments of laboratory evaluation of knowledge and skills (weighting coef. 0.125 each) + Continuous assessment of behavior and attitudes (weighting coefficient 0.05).
Language Portuguese. Tutorial support is available in English.
Last updated on: 2021-06-17

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