Curricular Unit:Code:
Pharmaceutical Technology IV843TFA4
Year:Level:Course:Credits:
4MasterPharmaceutical Sciences5 ects
Learning Period:Language of Instruction:Total Hours:
Spring SemesterPortuguese/English65
Learning Outcomes of the Curricular Unit:
In this course, the students should acquire basic and specific knowledge, skills and abilities to formulate, prepare and control formulations of the clinical prescription, allowing them to take industrial responsibility as regard to ophthalmic, nasal, otic, parenteral and pulmonar dosage forms.
Skills:
- Understand the operating mode of the ophthalmic, nasal, auricular, parenteral and pulmonar preparations depending on the route of administration;
- Identify the most used raw materials in the preparation of pharmaceutical dosage forms for ophthalmic, nasal, auricular, parenteral and pulmonary administration;
- Analyze formulations prepared for ophthalmic, nasal, auricular, parenteral and pulmonary and administration: identify all components and know their role, indications, laboratorial and industrial preparation procedures and quality control;
- Formulate simple preparations to obtain a certain action in accordance with the route of administration
Syllabus:
Theoretical
1. Preparation of sterile products: Manipulation with aseptic technique
2. Ophthalmic preparations
Anatomy and physiology of the eye; Absorption; Monograph; Requirements; Excipients, preparation; Control; Packaging
3. Nasal preparations
Anatomy and physiology of the nasal mucosa; Factors affecting the integrity of the nasal epithelium; Monograph; Excipients; Preparation; Control; Packaging
4. Auricular preparations
Anatomy and physiology of the ear canal; monograph; excipients; preparation; Control; Packaging.
5. Parenteral preparations
Routes of administration; monograph; requirements; excipients; Final and extemporaneous preparations; Verification tests; Packaging
6. Pulmonary preparations
Anatomy and physiology of the respiratory system; Monograph; Pulmonary administration; Pressurized preparations and inhalation devices; Excipients; Control
Practical-laboratory
Compounding of ophthalmic, nasal, auricular, and parenteral formulations.
Demonstration of the Syllabus Coherence with the Curricular Unit's Objectives:
The main objective of Pharmaceutical Technology IV is to study pharmaceutical preparations for ophthalmic, nasal, auricular and parenteral administration. For these purposes concepts related to drug substances and excipients, their incompatibilities, pharmacological actions and bioavailability, formulation, production at laboratory and industrial level, conservation and packaging and quality control will be addressed.
The subject also aims to provide students with skills for the formulation, preparation and quality control of the referred pharmaceutical preparations, allowing the analysis, preparation and control of clinical formulations prescription, with regard to ophthalmic, nasal, auricular, pulmonary and parenteral dosage forms.
Teaching Methodologies (Including Evaluation):
Theoretical (70%): will be presented succinctly, organizational and descriptive, the concepts, theories that form the basis of the syllabus. This exhibition will be accompanied whenever possible with audiovisual material. In order to acquire the skills, students will be encouraged to deepen their knowledge and to seek their application in the analysis other formulations than those covered in class. Upon request, the teacher will clarify the doubts and guide the study of the student. Assessment: 2 written tests.
Practical-laboratory (30%): will be transmitted knowledge about equipment and preparation techniques of provided formulations. The student will research on the components of formulations and their roles, indications, laboratory preparation mode and quality control. During class, students will perform the work based on the research clarifying the doubts. Assessment: ongoing independent performance of activities (30%) and realization of a laboratory examination (70%).
Demonstration of the Coherence between the Teaching Methodologies and the Learning Outcomes:
The theoretical written evaluation allows evaluating the scientific expertise and systematization of knowledge acquired by students throughout the semester. The laboratory evaluation through continuous work and the development of a laboratory formulation allows evaluating the skills acquired at the laboratory level. In order to acquire the skills and the necessary skills, students will be encouraged to deepen the knowledge acquired in class and to seek its practical application. All activities with evaluative nature will be awarded credits (ECTS) properly proportional to the number of total credits. ECTS planned for the work-study student only will be fully allocated or not, depending on the performance demonstrated by the student, in particular with regard to the planned acquisition of knowledge and skills. In addition to the assessments referred to, it will be given to students opportunities to demonstrate that it met the proposed objectives through evaluation moments if the teacher or the student understands the requests. These elements may be considered if it appears to benefit the student.The theoretical written evaluation allows evaluating the scientific expertise and systematization of knowledge acquired by students throughout the semester. The laboratory evaluation through continuous work and the development of a laboratory formulation allows evaluating the skills acquired at the laboratory level. In order to acquire the skills and the necessary skills, students will be encouraged to deepen the knowledge acquired in class and to seek its practical application. All activities with evaluative nature will be awarded credits (ECTS) properly proportional to the number of total credits. ECTS planned for the work-study student only will be fully allocated or not, depending on the performance demonstrated by the student, in particular with regard to the planned acquisition of knowledge and skills. In addition to the assessments referred to, it will be given to students opportunities to demonstrate that it met the proposed objectives through evaluation moments if the teacher or the student understands the requests. These elements may be considered if it appears to benefit the student.
Reading:
1) PRISTA, L.N., CORREIA ALVES, A., MORGADO, R., SOUSA LOBO, J. Tecnologia Farmacêutica III, 8ª Edi. Fundação Calouste Gulbenkian, Lisboa, 2013.
2) Farmacopeia Portuguesa 9; Edição Oficial; Instituto Nacional da Farmácia e do Medicamento, Lisboa, 2008.
3) CARMEN LOZANO et al., Manual de Tecnología Farmacéutica. Elsevier, Barcelona, 2012 ISBN: 978-84-8086-600-2
4) US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (2004), Guidance for Industry Sterile Drug Products produced by aseptic. Current Good Manufacturing Practices.
5) Fox, S. C. Remington Education. Pharmaceutics. PhP (Pharmaceutical Press), 2014.
6) www.infarmed.pt