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Galenic Formulation and Development Course

Code 13700
Year 5
Semester S1
ECTS Credits 3
Workload PL(10H)/T(10H)/TP(10H)
Scientific area Ciências Farmacêuticas
Entry requirements Previous frequency of the UC Farmácia Galénica e Tecnologia Farmacêutica or equivalent.
Learning outcomes The general learning goals are: 1. To analyze the industrial drug product life cycle, with focus on the context of the paradigm “Quality by Design”; 2. To discuss, and learn how to use, the tools that support this new paradigm; 3. To develop competences in the development of new formulations applying these and previous knowledge (Galenic Pharmacy). The students should acquire the ability to: 1. Describe the evolution of the drug product and active substances quality concept, and of the ways to demonstrate and assure it; 2. To develop formulation of medicines making use of the tools of the “Quality by Design” paradigm and working as a team; 3. To discuss some aspects of scale transposition, process validation and drug product manufacture management.
Syllabus Global vision of formal aspects: drug product life cycle and applications for marketing authorization; International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); “Common Technical Document” (CTD) and quality modules; Good manufacturing practices; 2. Introduction of basic concepts and vocabulary [Six Sigma method, quality control – including statistical quality control, “Design of experiments (DoE), “Quality Management Systems” (ISO 9000:2005), “Knowledge management”, etc.]; 3. Evolution of the concepts related with medicine quality and ICH guidelines [“Process analytical technology” (PAT), “Quality by design”(QbD), “Quality risk management” (QRM) e “Pharmaceutical quality systems” (PQS), etc.]; 4. Pre-formulation and formulation during the preclinical phase of drug product design; 5. Scale transposition, process validation and production management;
Main Bibliography http://www.infarmed.pt; http://www.ich.org; http://www.fda.gov/; http://www.ema.europa.eu/ema/; ISO 9000:2005; Allen, T.T., 2006. Introduction to engineering statistics and six sigma: statistical quality control and design of experiments and systems, 1st ed. ed. Springer, London.; Lachman, L., Lieberman, H.A., Kanig, J.L., Pinto, J.E., Fernandes, 2001. Teoria e prática na indústria farmacêutica. Fundação Calouste Gulbenkian, Lisboa.; Vários artigos científicos de publicações periódicas.
Teaching Methodologies and Assessment Criteria Mixed methodologies of lectures and tutorial classes – 15 h; Laboratorial courses – 15 h, The evaluation will include a written evaluation test (8 values), Evaluation of the report of the laboratorial work, individual laboratorial competences evaluation (3 values), Individual qualitative attitudes evaluation (1 values).
Language Portuguese. Tutorial support is available in English.
Last updated on: 2018-07-30

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