| Code |
13676
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| Year |
4
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| Semester |
A1
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| ECTS Credits |
16
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| Workload |
PL(30H)/T(30H)/TP(60H)
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| Scientific area |
Ciências Farmacêuticas
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Entry requirements |
not appllicable
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Mode of delivery |
Face-to-face
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Work placements |
Not applicable.
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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.
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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.
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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.
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Teaching Methodologies and Assessment Criteria |
1. Theoretical master classes
2. Theoretical-practical classes - tutorial/self-learning regime and exercise resolution (subdivided into 2 shifts)
3. Laboratory classes (4 shifts)
The evaluation, expressed on a scale of 0-20 values, consists of:
- Periodic Evaluation of Theoretical Knowledge (APCT)
- Practical Skills Assessment (PCA)
- Continuous Assessment of Behaviors and Attitudes (ACCA)
Each component contributes to the calculation of the final classification (FC), without any rounding, according to the following equation: CF = 0.8(APCT)+0.15(ACP)+0.05(ACCA)
The APCT has 10 parts, 1 test in each PU (UP1 to UP6), and two integrative tests, in the middle and at the end of the year, with two parts each, theoretical (IT) and practical (IP), following the following equation:
APCT=0.1*(UP1+UP2+UP3+UP6)+0.1125*(UP4+UP5)+0.125(IT1+IT2)+0.0625(IP1+IP2)
The ACP has two evaluation moments, in the middle and at the end of the year, following the following equation:
ACP=0.5(ACP1 + ACP2)
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Language |
Portuguese. Tutorial support is available in English.
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