| Code |
13676
|
| Year |
4
|
| Semester |
A1
|
| ECTS Credits |
16
|
| Workload |
PL(60H)/T(36H)/TP(64H)
|
| 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. 2021. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. 4th ed. Edinburgh: Churchill Livingstone/Elsevier; Farmacopeia Portuguesa 9ª ed., Infarmed, 2008; European Pharmacopoeia ed 10; 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.
|
|
Language |
Portuguese. Tutorial support is available in English.
|