Pharmaceutical Products and Processing

Recommended Prerequisites

NA

Teaching Methods

Theoretical classes: oral exposition, using audiovisual support materials and internet access. Theoretical concepts will be accompanied and supported by application examples and case studies.

Tutorial classes: tasks/projects/monographs selection (proposed by students/teacher), tutorial supervision by teacher (during the whole semester). Students will be organized in groups.

Special seminars (to be presented by specialist guest lecturers - academic/industrial) will be scheduled. Field visits to pharmaceutical companies will be organized.

Learning Outcomes

The main goal of this course is the acquisition/development of basic/specific knowledge/skills in the fields of the discovery/development of new drugs/medicines, and of pharmaceutical processing (APIs and medicine manufacturing). The involved regulatory requirements, and particularly “Good Manufacturing Practices” - GMPs, will be covered in detail. A multidisciplinary perspective is always provided. Other course goals are related to the expansion and application of some of the already acquired Chemical Engineering knowledge/skills (transformation and separation processes, quality systems, etc.) into the areas of pharmaceutical technology and pharmaceutical processes. Tasks/projects/monographs on the subjects covered in this course will be proposed and will help to develop students’ synthesis skills. Special seminars (to be presented by specialist guest lecturers - academic/industrial) will be scheduled. Field visits to pharmaceutical companies will be organized.

Work Placement(s)

No

Syllabus

Theoretical component: introduction to drugs and to the pharmaceutical industry; diseases, targets and receptors; basic concepts of Pharmacy; medicines and routes of administration; pharmacodynamics; pharmacokinetics; toxicology; regulatory authorities: Portugal (Infarmed), Europe (EMA), USA (FDA), other: ICH, PIC/S WHO); regulatory issues towards market authorization; non-clinical studies (GLP); clinical studies and trials (GCP); Good Manufacturing Practices (cGMP); primary pharmaceutical processing – API manufacturing; secondary pharmaceutical processing – medicine manufacturing.

Head Lecturer(s)

Hermínio José Cipriano de Sousa

Assessment Methods

Assessment
Exam: 40.0%
Synthesis work: 60.0%

Bibliography

Ng, R, Drugs: From Discovery to Approval, 2nd Ed, Wiley-Blackwell, 2008

Bartfai, T, Lees, GV, Drug Discovery - From Bedside to Wall Street, Elsevier, 2006

Patravale, VB, DiSouza, JI, Rustomjee, M (Eds), Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs, 1st Ed, CRC Press, 2016

Bennett, B, Cole, G (Eds.), Pharmaceutical Production, An Engineering Guide, IChemE, 2003

Swarbrick, J (Ed), Encyclopedia of Pharmaceutical Technology, 3rd Ed, Vols 1-3, Informa Healthcare, 2007

Nally, JD (Ed), Good Manufacturing Practices for Pharmaceuticals, 6th Ed, Informa Healthcare, 2007

Prager, G, Practical Pharmaceutical Engineering, 1st Ed, Wiley, 2018

am Ende, DJ (Ed), Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing, 1st Ed, Wiley, 2010

Jagschies, G, Lindskog, E, Lacki, K, Galliher, PM (Eds), Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes, 1 st Ed, Elsevier, 2018