Medicinal Product Quality Control

Recommended Prerequisites

Relevant curricular units:

- Laboratory Methodologies (1^st Y/1^st S)

- Analytical Chemistry (1^st Y/2^nd S)

- Instrumental Analysis (2^nd Y/1^st S)

- Metrology and Analytical Validation (2^nd Y/2^nd S)

- Analytical Technologies (2^nd Y/2^nd S)

- Drugs and Medication (2^nd Y/2^nd S)

 

Recommended basic knowledge:

- Medication

- Drugs

- Pharmaceutical dosage forms

- Analytical methods applied to medication

- Quality control concepts

Teaching Methods

- Lectures, with incentive to the students active participation, by stimulating critical thinking;

- Practical laboratory lessons;

- Writen exercises regarding data analysis of the results obtained from the laboratory lessons.

Learning Outcomes

- Mastering the concept of medication;

- Having in mind a clear distinction between the different types of pharmaceutical dosage forms;

- Knowing when in a medicines' life cycle its quality control is applied;

- Deep knowledge and know-how of the quality control assays that are applied to the different pharmaceutical dosage forms, and general assays applied to all of them;

- Knowledge of quality control standard guidelines applied in the pharmaceutical industry.

Work Placement(s)

No

Syllabus

- Quality control of solid dosage forms: granulometry, flow properties, apparent volume, weight uniformity, humidity, porosity, disaggregation, dissolution, resistance, hardness, melting point, liquefaction time, etc.;

- Quality control of liquid dosage forms: pH, osmolality, viscosity, particle size, weight/released dose/filling uniformity, sterility, pirogenicity, polarimeric properties, density, stability, etc.;

- Quality control of semisolid dosage forms: pH, consistency, plasticity,  interfacial tension, difusion/dissolution, sterility, particle size, weight/volume, etc.;

- Control of active substances: content uniformity, identification and quantification, release, permeation, pharmacokinetic and pharmacodynamic assays;

- Pharmaceuticals quality control guidelines.

Head Lecturer(s)

Patrícia Sofia Cabral Pires

Assessment Methods

Assessment
Resolution Problems: 30.0%
Exam: 70.0%

Bibliography

- L. Nogueira Prista, A. Correia Alves, Rui Morgado, J. Sousa Lobo, “Tecnologia Farmacêutica”, I Volume, 8ª Edição, Fundação Calouste Gulbenkian, Lisboa, 2014;

- L. Nogueira Prista, A. Correia Alves, Rui Morgado, J. Sousa Lobo, “Tecnologia Farmacêutica”, II Volume, 8ª Edição, Fundação Calouste Gulbenkian, Lisboa, 2014;

- L. Nogueira Prista, A. Correia Alves, Rui Morgado, J. Sousa Lobo, “Tecnologia Farmacêutica”, III Volume, 8ª Edição, Fundação Calouste Gulbenkian, Lisboa, 2013;

- Farmacopeia Portuguesa VIII, Instituto Nacional da Farmácia e do Medicamento (INFARMED), 2005;

- United States Pharmacopeia 37, United States Pharmacopeial Convention, 2014;

- Decreto-Lei n.º 176/2006;

- Directiva 2003/94/CE;

- Directiva 2010/63/EU.