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511-0100-00L 2 Credits MSC D-CHAB

Module 1: Advanced drug product development and Industrialization

Modul 1: Advanced drug product development and Industrialization

Lecturers & Examiners: Dr. Bruno Galli
VVZ CR n/a

Last Updated: 2026-02-05 15:28:25

Abstract

Selected professionals with hands-on experience in the field provide an advanced training for one of the core disciplines in Industrial Pharmacy: formulation.Concepts and the path from the experimental dosage form principle to an industrialized product are discussed.

Objective

o Understand and appreciate activities, building-blocks, processes and guiding ideas at the different stages of a Drug Product Development (exploratory, bridging, prototyping, industrialization, confirmatory) o Be familiar with specific vocabulary o Able to translate data into thoughts, questions and processes o Able to develop scientifically consistent, realistic and sound information. o Able to challenge „current and next, envisaged steps“

Content

o Recapitulation of basics o Exposure to main questions in the field o “Established” versus “advanced” state of the art o Rationale for selecting a Dosage Form principle and its excipients o Screening of variants and accelerations of processes o Iterative development of a drug product o Up-scaling and industrialization of drug products o Timing that rules a Drug Product Development

Resources

Lecture Notes

Handouts are distributed at the beginning of the course; electronic version available on the webpage (http://www.galenik.ethz.ch/teaching/index; login and password necessary).

Literature

o C.-D. Herzfeldt und J. Kreuter (Hrsg.) Grundlagen der Arzneiformenlehre, Springer Verlag, Berlin 1999 o H. Leuenberger (Hrsg.) Martin - Physikalische Pharmazie, Wissenschaftliche Verlagsgesellschaft, Stuttgart 2002 o K.H. Bauer, K.-H. Frömming, C. Führer, Lehrbuch der Pharmazeutischen Technologie, 8. Auflage, Wissenschaftliche Verlagsgesellschaft, Stuttgart, 2006 o R. Voigt, Pharmazeutische Technologie, 10. Auflage, Deutscher Apotheker Verlag, Stuttgart, 2006 o Relevant papers in the field

General Information

Language
English
Levels
MSC
Frequency
Yearly recurring

Examination

Type
graded semester performance

Course Components

Type Title Time & Place Hours
lecture with exercise Advanced drug product development and Industrialization
Permission from lecturers required for all students.
No time listed 2 h weekly

Offered In