The course focuses on manufacturing of pharmaceuticals, and cover in particular separation processes in the manufacturing of the active pharmaceutical ingredients and pharmaceutical unit operations for solid dosage forms. The course focuses on batch processing and agitated tank operations, in multipurpose, multiproduct plants with emphasis on the influence of physico-chemical and processing conditions on process result and product properties. The course gives a detailed description and analysis of crystallization, agitation and mixing, distillation, drying, extraction and chromatography under these conditions. The course then continues with a description of in particular solid oral dosage forms, pharmaceutical excipients, and important pharmaceutical unit operations like granulation, grinding and tabletting.
The course contains also aboratory exercises. Each exercise includes to design an experimental plan to solve a given problem, laboratory work and analysis of results. A literature review over design and manufacturing of a given solid dosage form is to be performed by each student.
The course contains group assignments, oral presentations , discussions and written reporting, and accordingly contributes to the corresponding programs goals.
After the course the student should be able to:
- describe a batchwise production plant for production of pharmaceuticals and explain the benefits and drawbacks of this mode of production
- describe the mechanisms and performance of unit operations like agitation and mixing, crystallization, extraction, distillation, drying and chromatography in production of pharmaceuticals
- describe excipients and their function in pharmaceutical dosage forms
- describe and understand manufacturing of pharmaceutical dosage forms, and the mechanisms and performance of important pharmaceutical unit operations
- acquire and evaluate information from technical/scientific litterature and other sources of information for the purpose of developement and design of new processes, or for improvement or trouble shooting of current processes
- plan, design and perform experiments to develop and design new processes, or for improvement or trouble shooting of current processes
- perform calculations over design, performance, operation and scaleup/scaledown of processes
- analyse processes and propose technically feasible and economically viable solutions to process problems or needs for improvement
- evaluate and prioritize measures to improve processes or product properties from technical, economical, safety and environmental points of view
The course contains group assignments, oral presentations , discussions and written reporting, and accordingly contributes to the corresponding programs goals.