Curricular Unit:Code:
Pharmaceutical Technology II843TFA2
Year:Level:Course:Credits:
3MasterPharmaceutical Sciences6 ects
Learning Period:Language of Instruction:Total Hours:
Spring SemesterPortuguese/English78
Learning Outcomes of the Curricular Unit:
To acquire capabilities for the formulation, preparation and quality control of liquid dosage forms at the industrial level as well as analysis, preparation and quality control of the formulas of the clinical prescription of dosage forms such as solutions, colloidal dispersions, suspensions, emulsions;
- To know the administration routes of liquid preparations and to relate with other ways of administration;
- To identify all the components used in the preparation of liquid pharmaceutical forms; - To analyze formulations of liquid preparations: to identify to all the components and to know its function, indications, laboratorial procedure and industrial production as well as quality control;
- To formulate simple liquid preparations to a certain route of administration
- To evaluate the stability of medicines and to determine its expire date.
Syllabus:
Theoretical:
1. Solutions: dissolution and solubility; factors that influence the solubility; drug solubility; filtration and centrifugation; solvents used and additives. Formulation, preparation, stability and quality control of: aqueous solutions, non-aqueous solutions. 2. Extractive dissolution: extracts and complementary forms
3. Alcoholic solutions: simple alcoholic solutions, tinctures and alcoholatures;
4. Pharmaceutical forms obtained by distillation
5. Pharmaceutical forms obtained by mechanic dispersion: formulation, preparation, stability and quality control of colloidal dispersions, suspensions and emulsions;
6. Stability of medicines: kinetic of the degradation reactions, stability studies and determination of expiration date of medicines.
Laboratorial: Laboratorial preparation of liquid dosage forms: solutions, colloids, suspensions and emulsions; calculation of expire date.
Demonstration of the Syllabus Coherence with the Curricular Unit's Objectives:
The Curricular Unit has as main objective to obtain liquid pharmaceutical preparations. 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 liquid pharmaceutical preparations allowing the analysis, preparation and monitoring of clinical formulations of prescription in respect with solutions, colloids, suspensions, emulsions. Students should also acquire knoledge about stability and expiration date of dosage forms.
Teaching Methodologies (Including Evaluation):
In 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. Theoretical assesment include 2 written tests; In laboratory classes will be transmitted knowledge about equipment and techniques for the preparation of various formulations provided. The student will be encouraged to research the formulation components and know their role, indications, mode of preparation and the respective laboratory quality control. During the lesson the student will perform laboratory work based on his research clarifying the questions with the teacher. Laboratory assesment will include 1 pratical test and the work in the laboratory.
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 liquid dosage forms. 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