Curricular Unit:Code:
Pharmaceutical Technology I1202TFA1
Year:Level:Course:Credits:
2MasterPharmaceutical Sciences5 ects
Learning Period:Language of Instruction:Total Hours:
Spring SemesterPortuguese/English65
Learning Outcomes of the Curricular Unit:
The purpose of this course is to provide the basic and specific knowledge that allow acquire the ability and competences to formulate, prepare and control formulations of clinical prescription, allowing them to take industrial responsibility in respect of the preparation and quality control of oral solid dosage forms (i.e. pharmaceutical powders, granules, soft tablets, capsules, tablets, coated and special solid dosage forms).
Syllabus:
Pharmaceutical powder: Characterization of the active substances and excipients; Preparation; Pulverization; Mixture; Alterations; Incompatibilities.
Granules: Theory granulation; General concepts and granulated preparation techniques.
Soft tablets: preparation, alterations.
Capsules: Types and techniques of obtaining the soft capsules; hard capsules; soft capsules; gastro-resistant capsules; Incompatibilities.
Tablets: Characteristics of the material to compress; Compression physical; Preparation; Special types of tablets; Alterations.
Coated solid dosage forms: different dragged-making processes.
Pharmaceutical powder, granules, capsules, tablets, and coated pharmaceutical forms: Verification tests: physical, physicochemical and stability tests; Packaging: packaging materials and types of packaging; Formulary. Legislation.
Practical-laboratory classes
Laboratory preparation of solid dosage forms: powders, granules, capsules and tablets.
Demonstration of the Syllabus Coherence with the Curricular Unit's Objectives:
The main objective of Pharmaceutical Technology I is to obtain solid pharmaceutical preparations. For these purposes concepts of 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 solid pharmaceutical preparations, allowing the analysis, preparation and control of clinical formulations prescription, with regard to pharmaceutical systems such as pharmaceutical powders, granules , capsules, tablets, coating and special solid 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; 8ª edição; Vol. I, Fundação Calouste Gulbenkian; Lisboa; 2011.
2) AULTON, The Science of Dosage Form Design, 3rd Churchill Livingston Ed; 2008
3) ROWE, R.C., SHESKEY, P.J., WELLER, P.J. Handbook of Pharmaceutical Excipients. London: Pharmaceutical Press, 2003
4) Farmacopeia Portuguesa 9; Edição Oficial; Instituto Nacional da Farmácia e do Medicamento; Lisboa; 2008.
5) CARMEN LOZANO et al., Manual de Tecnología Farmacéutica. Elsevier, Barcelona, 2012 ISBN: 978-84-8086-600-2
6) Remington: the science and practice of pharmacy: Limmer, D. (ed.) 2013 22nd Ed. Lippincott Williams & Wilkins, Philadelphia
7) www.infarmed.pt