KE2330 Sustainable Production of Pharmaceuticals 9.0 credits
An advanced module about the manufacture of drugs. The contents include separation processes and unit operations of relevance in the production of mainly solid pharmaceutical dosage forms. The focus is on batch-wise processes, in multi-purpose, multi-product plants, with emphasis on the influence of physico-chemical and processing conditions on the resulting product properties.
Content and learning outcomes
Course contents
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.
Intended learning outcomes
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.
Literature and preparations
Specific prerequisites
At least 150 credits from grades 1, 2 and 3 of which at least 110 credits from years 1 and 2, and bachelor's work must be completed, within a programme that includes:
75 university credits (hp) in chemistry or chemical engineering, 20 university credits (hp) in mathematics and 6 university credits (hp) in computer science or corresponding.
Recommended prerequisites
KE1020 Reaction and Separation Engineering
KE1030 Transport Phenomena and Engineering Thermodynamics
KE2070 Transport Phenomena, Advanced Course
Equipment
Literature
Examination and completion
If the course is discontinued, students may request to be examined during the following two academic years.
Grading scale
Examination
- LAB1 - Experimental Laborations, 3.0 credits, grading scale: P, F
- LIT1 - Literature Review, 1.5 credits, grading scale: P, F
- TEN1 - Examination, 4.5 credits, grading scale: A, B, C, D, E, FX, F
Based on recommendation from KTH’s coordinator for disabilities, the examiner will decide how to adapt an examination for students with documented disability.
The examiner may apply another examination format when re-examining individual students.
Opportunity to complete the requirements via supplementary examination
Opportunity to raise an approved grade via renewed examination
Examiner
Ethical approach
- All members of a group are responsible for the group's work.
- In any assessment, every student shall honestly disclose any help received and sources used.
- In an oral assessment, every student shall be able to present and answer questions about the entire assignment and solution.