2024
Pharmaceutical Technology I
Name: Pharmaceutical Technology I
Code: CMS13773I
6 ECTS
Duration: 15 weeks/156 hours
Scientific Area:
Ciências Farmacêuticas
Teaching languages: Portuguese
Languages of tutoring support: Portuguese
Presentation
This Units aims to provide the students with knowledge in the field of Pharmaceutical Technology, namely in pharmaceutical operations for solid and semisolid dosage forms, for all routes of administration, with their advantages and disadvantages highlighted.
Sustainable Development Goals
Learning Goals
The students should:
1. Understand the properties of the solid state, as well as the advantages of the production of solid pharmaceutical formulae.
2. Link the different physiological characteristics of the patients with the intrinsic properties of the drugs, identifying and developing the appropriate pharmaceutical form.
3. Know the development process, the production and the quality control assays of solid and semisolid pharmaceutical forms, from a molecular point of view to the final pharmaceutical product.
4. Comprehend the different components of the production process of solid and semisolid pharmaceutical forms, concerning matrixes and particles and the basic operations required for preparation.
5. Correlate the characteristics of the drug with the packaging envisaged for storage (techniques and materials used).
6. Acknowledge the conventional and the new Process Analytical Technologies (PAT) on the production and quality control assessment of pharmaceutical forms.
1. Understand the properties of the solid state, as well as the advantages of the production of solid pharmaceutical formulae.
2. Link the different physiological characteristics of the patients with the intrinsic properties of the drugs, identifying and developing the appropriate pharmaceutical form.
3. Know the development process, the production and the quality control assays of solid and semisolid pharmaceutical forms, from a molecular point of view to the final pharmaceutical product.
4. Comprehend the different components of the production process of solid and semisolid pharmaceutical forms, concerning matrixes and particles and the basic operations required for preparation.
5. Correlate the characteristics of the drug with the packaging envisaged for storage (techniques and materials used).
6. Acknowledge the conventional and the new Process Analytical Technologies (PAT) on the production and quality control assessment of pharmaceutical forms.
Contents
1. Basic pharmaceutical operations I: pulverization, separation, spray-drying (micro and nano), mixture (solids) and granulation;
2. Solids: tablets, immediate release (instant dissolution, conventional tablets and effervescent), tablets, controlled release (prolonged and selected release), capsules (soft and hard), granules, powders for lung delivery (DPIs, MDIs, microparticles), powders for cutaneous application, powders for parenteral administration, particle engineering (related to spray-drying), suppositories, vaginal anf transdermal;
3. Excipients I (solids);
4. Semisolids: ointments (hydrophobes, water absorbant, hydrophilic), creams (hydrophobes, hydrophilic), gels (oleogeles, hidrogeles), pastes and ophthalmic dosage forms I;
5. Excipients II (semisolids);
6. Stability I: solid degradation and Active Pharmaceutical Ingredient (API) leakage;
7. Industry I: pre-formulation studies, scale-up, physicochemical characterization and quality control.
2. Solids: tablets, immediate release (instant dissolution, conventional tablets and effervescent), tablets, controlled release (prolonged and selected release), capsules (soft and hard), granules, powders for lung delivery (DPIs, MDIs, microparticles), powders for cutaneous application, powders for parenteral administration, particle engineering (related to spray-drying), suppositories, vaginal anf transdermal;
3. Excipients I (solids);
4. Semisolids: ointments (hydrophobes, water absorbant, hydrophilic), creams (hydrophobes, hydrophilic), gels (oleogeles, hidrogeles), pastes and ophthalmic dosage forms I;
5. Excipients II (semisolids);
6. Stability I: solid degradation and Active Pharmaceutical Ingredient (API) leakage;
7. Industry I: pre-formulation studies, scale-up, physicochemical characterization and quality control.
Teaching Methods
The T classes will be predominantly expositive, and they will be complemented with TP sessions. The latter intends to give students the tools to establish links between every subject discussed by means of practical exercises, and to stimulate their critical thinking.
The PL classes are a complement of the T/TP, in which the students will plan and develop practical formulae from the theoretical concepts.
In the S class, an invited professional, with expertise in Industry, will share his/her experience, and it will help students to integrate the theoretical concepts in a real-world setting. In the TC, with the visit to the pharmaceutical industry, the perspective of scale-up will take place.
Evaluation:
• T/TP (60%) a final exam (or two evaluations)
• PL (40%) the performance in the PL classes and the elaboration of the respective reports (10%), a final practical exam (20%) and an oral group presentation of a certain subject (10%).
The PL classes are a complement of the T/TP, in which the students will plan and develop practical formulae from the theoretical concepts.
In the S class, an invited professional, with expertise in Industry, will share his/her experience, and it will help students to integrate the theoretical concepts in a real-world setting. In the TC, with the visit to the pharmaceutical industry, the perspective of scale-up will take place.
Evaluation:
• T/TP (60%) a final exam (or two evaluations)
• PL (40%) the performance in the PL classes and the elaboration of the respective reports (10%), a final practical exam (20%) and an oral group presentation of a certain subject (10%).
Certificações
