Curricular Unit:Code:
Pharmaceutical Technology III844TFA3
Year:Level:Course:Credits:
4MasterPharmaceutical Sciences5 ects
Learning Period:Language of Instruction:Total Hours:
Portuguese/English65
Learning Outcomes of the Curricular Unit:
To know the routes of administration of the semisolid preparations, with particular incidence on the skin, and to relate with other routes of administration.
- To identify the ingredients used in the preparation of semisolid pharmaceutical forms, patches, rectal and vaginal forms;
- To analyze semisolid, rectal and vaginal forms: to identify to all the components and to know its function, indications, laboratorial and industrial preparation and quality control;
- To formulate simple semisolid preparations according to a therapeutical action and route of administration;
- to distinguish dermal an transdermal administrations;
- To know the characteristics of molecules to be delivered by transdermal route;
- To know the composition of the different types of transdermal patches.
Syllabus:
Theoretical: 1. Semisolid pharmaceutical forms: factors that affect dermal and transdermal permeation; classification of the semisolid forms; absorption promoters; ingredients for the preparation of semisolid forms; semisolid bases (oily, absorption, emulsified, water soluble); preparation and formulation of ointments, creams, pastes and gels; industrial production; quality control of finished product in accordance with GMP and ICH. 2. Transdermal pharmaceutical forms: transdermal drug delivery; types of transdermal systems; drug release profile; preparation and quality control; evaluation of commercial products. 3. Rectal and vaginal pharmaceutical forms: factors that influence the rectal and vaginal absorption; ingredients used in the preparation of suppositories and pessaries; preparation and quality control; anomalies of the suppositories and pessaries; other rectal and vaginal. Laboratorial: preparation of semisolid pharmaceutical forms, rectal and vaginal forms
Demonstration of the Syllabus Coherence with the Curricular Unit's Objectives:
The Curricular Unit has as main objective to obtain dermal vehicles, transdermal drug delivery systems, retal and vaginal forms . For this purpose concepts about raw materials and medicinal substances, their incompatibilities, pharmacological actions and bioavailability, formulation, production at laboratory and industrial level, conservation and packaging and quality control will be addressed.
Thus, the curricular unit provide students with skills for the formulation, preparation and quality control of pharmaceutical preparations allowing the analysis, preparation and monitoring of clinical formulations of prescription in respect with creams, ointments, pastes, gels, suppositories, vaginal suppositories .
Teaching Methodologies (Including Evaluation):
n the theoretical classes will be presented concepts, theories and mechanisms that underlie the syllabus of these lessons. This exhibition will be accompanied with appropriate audiovisual material. Students will be encouraged to deepen their knowledge and to seek its application in the analysis of new formulations, beyond those in the lectures. When asked, the teacher will clarify the questions and guide student study. The theoretical component will be assessed through two written tests (60% 1st test e 40% 2nd test); the laboratory component will be evaluated through continuous assessment (30%) in each lesson of the quality and quantity of student work and achievement of a laboratory formulation without consultation with the preparation of a report (70%). The final grade is given by the scores of the theoretical and laboratory components weighting 70% and 30% respectively.
Demonstration of the Coherence between the Teaching Methodologies and the Learning Outcomes:
The theoretical classes will endow the students with knowledge about excipients, active substances, incompatibilities, therapeutic actions, bioavailability, formulation, industrial and laboratory production, stability and quality control. The aim of practical-laboratorial classes is that students acquire capabilities of basic galenic compounding familiarizing with the equipment and preparation of semisolid dosage forms nad vaginal and rectal products. The verification of the acquisition of knowledge will be obtained through the evaluation of the autonomous work. However, assessment methodologies provided include writing tests, on the grounds that only this form of evaluation allows a full and thorough assessment of the capacities, scientific skills and the systematization of knowledge that students must acquire in the course.
Reading:
(1) PRISTA, L.N., CORREIA ALVES, A., MORGADO, R.; Tecnologia Farmacêutica; 5º edição; vol. I, II e III; Fundação Calouste Gulbenkian; Lisboa; 1995
(2) AULTON, M.E.; Pharmaceutics: the science of dosage form design; 2th edition; Elsevier; 2002
(3) TRILLO, C.F.; Tratado de Farmacia Galénica; 1ª edição; Luzán 5, S.A.; Madrid; 1993
(4) Farmacopeia Portuguesa 9; Edição Oficial; Instituto Nacional da Farmácia e do Medicamento; Lisboa; 2008
(5) LACHMAN, L.; LIEBERMAN; H.A.; Teoria e prática na Indústria Farmacêutica; vol. I e II; Fundação Calouste Gulbenkian; Lisboa; 2001