2024
Pharmaceutical Chemistry II
Name: Pharmaceutical Chemistry II
Code: CMS13774I
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 pharmaceutical operations of liquid and parenteral dosage forms, from their unit operations to regulatory aspects, and the analytical technologies in process of manufacture and product quality control.
Sustainable Development Goals
Learning Goals
The students should:
1. Understand the properties of the liquid state, as well as the importance of producing liquid and parenteral dosage forms;
2. Relate the physiological characteristics of patients and the intrinsic properties of medicines, with the identification and development of the appropriate pharmaceutical form;
3. Know the process of development, production and quality control of liquid and parenteral pharmaceutical forms, from a molecular perspective towards the final product;;
4. Understand the production process of liquid and parenteral forms (unit operations and regulatory aspects);
5. Relate the characteristics of the medicine, with the techniques, materials and characteristics of the packaging for storage;
6. Recognize the conventional and the new analytical technologies in process (PAT) of manufacture and product quality control;
7. Understand the new pharmaceutical forms, as well as their perspectives of therapeutic applicability.
1. Understand the properties of the liquid state, as well as the importance of producing liquid and parenteral dosage forms;
2. Relate the physiological characteristics of patients and the intrinsic properties of medicines, with the identification and development of the appropriate pharmaceutical form;
3. Know the process of development, production and quality control of liquid and parenteral pharmaceutical forms, from a molecular perspective towards the final product;;
4. Understand the production process of liquid and parenteral forms (unit operations and regulatory aspects);
5. Relate the characteristics of the medicine, with the techniques, materials and characteristics of the packaging for storage;
6. Recognize the conventional and the new analytical technologies in process (PAT) of manufacture and product quality control;
7. Understand the new pharmaceutical forms, as well as their perspectives of therapeutic applicability.
Contents
1. Basic pharmaceutical operations II: mixing (liquids), filtration, drying, lyophilization and sterilization;
2. Liquids: solutions (solutions, syrups, elixirs, mouthwashes, gargle solutions), emulsions (oral, as an encapsulation vehicle), suspensions (immediate and controlled release), ophthalmic dosage forms II, lotions, liniments, foams, shampoos, excipients, GRAS excipients and nanoparticles (polymeric, SLN, LNC, liposomes);
3. Excipients III (liquids);
4. Parenteral: asseptic techniques, dosage forms for injection (single and multidose, for infusion, concentrated solutions, implants), magnetic nanoparticles and parenteral nutrition;
5. Excipients IV (parenterals);
6. Stability II: liquids, parenterals and biologics;
7. Industry II: pre-formulation studies, scale-up, physicochemical characterization and quality control.
2. Liquids: solutions (solutions, syrups, elixirs, mouthwashes, gargle solutions), emulsions (oral, as an encapsulation vehicle), suspensions (immediate and controlled release), ophthalmic dosage forms II, lotions, liniments, foams, shampoos, excipients, GRAS excipients and nanoparticles (polymeric, SLN, LNC, liposomes);
3. Excipients III (liquids);
4. Parenteral: asseptic techniques, dosage forms for injection (single and multidose, for infusion, concentrated solutions, implants), magnetic nanoparticles and parenteral nutrition;
5. Excipients IV (parenterals);
6. Stability II: liquids, parenterals and biologics;
7. Industry II: 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
