Pharmaceutical technology

Recommended Prerequisites

Not applicable.

Teaching Methods

Theoretical lectures.
Final written exam.
Presentation and discussion of work.
Experimental follow-up.

Learning Outcomes

Curricular unit to standardize knowledge in the field of pharmaceutical technology, designed to provide students with fundamental knowledge of the development, formulation, preparation, control and stability of medicines.Provide knowledge of the particularities of parenteral dosage forms, namely the guarantee of their sterility
To know the specificity of the control of sterile liquid pharmaceutical forms Knowledge of relevant Pharmacopoeias and Guidelines for drug quality assurance.
Enable participants to outline the rational development of medicines and maintenance of their quality throughout their shelf life.Knowledge of the specificities of work in an aseptic environment Ability to differentiate the pharmacotechnical tests described in the Pharmacopoeias according to the type of drug product and its appropriate application;Ability to carry out pharmacotechnical control tests in pharmaceutical forms, in particular parenterals, according to European Pharmacopea.

Work Placement(s)

No

Syllabus

General principles of pharmaceutical technology including unit operations with emphasis on the preparation of dosage forms. Fundamentals of development and formulation. General properties of active substances with an impact on the formulation of a pharmaceutical form. Sterile products: particularities of their formulation and preparation. Excipients: water suitable for injections. Types of immediate packaging and their suitability. Sterilization processes: autoclaving and sterilizing filtration. Aseptic environment: creation and maintenance of clean rooms. Physical, chemical and microbiological quality control. Stability studies. Establishment of shelf life. Particular case of storage and transport of radiopharmaceuticals. Quality specifications concept. Creation of a Certificate of Analysis: universal and specific parameters for radiopharmaceuticals.

Head Lecturer(s)

Francisco José Batista Veiga

Assessment Methods

Assessment
Exam: 100.0%

Bibliography

Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 4th edition, Churcill Livingstone, M. E. Aulton (Ed.), Kevin M. G. Taylor, 2013. Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form, Informa Healthcare Press, Mark Gibson (Ed.), 2009. Pharmaceutical Dosage Forms: Tablets, Vol. 1 (Hardcover), 2nd edition, Herbert Lieberman (Editor), Leon Lachman (Editor), Joseph B. Schwartz (Editor), 1989
Wiley & Sons, Ltd
Handbook of Radiopharmaceuticals: Methodology and Applications, Second Edition. Editor(s):Peter Scott, Michael Kilbourn. First published:21 December 2020 Print ISBN:9781119500544 |Online ISBN:9781119500575 |DOI:10.1002/9781119500575, 2021 John Wiley & Sons, Ltd
Pharmaceutical Manufacturing Handbook: Production and Processes. Editor(s):Shayne Cox Gad PH.D., D.A.B.T.,First published:28 August 2007 Print ISBN:9780470259580 |Online ISBN:9780470259818 |DOI:10.1002/9780470259818, 2008 John Wiley & Sons, Inc.