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The Effect of Microcrystalline Cellulose as cushioning excipient during controlled release
Linköping University, Department of Physics, Chemistry and Biology, Chemistry.
2017 (English)Independent thesis Advanced level (degree of Master (Two Years)), 20 credits / 30 HE creditsStudent thesis
Abstract [en]

In the pharmaceutical industry, it is always important to have reproducible processes and raw materials of high quality to ensure good quality products. AstraZeneca, that is a leading manufacturer of different pharmaceuticals, works according to GMP to make sure that their processes deliver products of the same quality every time. A problem that has occurred at AstraZeneca is when a raw material is not properly understood and variations in the raw material affects the final product. Variations in drug release in one of AstraZeneca´s products, Product X, has been linked to the cushioning excipient Microcrystalline cellulose (MCC). Variations in drug release has been noticed during change from one batch of MCC to another. The aim of this study was to investigate which material attributes of MCC that contributes to variations in the final product. Particle size and moisture content were identified as critical material attributes (CMA´s) and were therefore chosen to be investigated more thoroughly. By variating particle size and moisture content during manufacturing of Product X, the influence of these attributes could be investigated using Design of Experiment (DoE). An additional experiment that compared two MCC batches from different suppliers was also performed during this study. The results from these experiments showed that the particle size and moisture content of MCC does affect the drug release. Large particles and high moisture content gave rise to a faster drug release compared to small particles and low moisture content that gave rise to a slower drug release. It is however hard to draw conclusions regarding how small differences in particle size and moisture content could affect the drug release. 

Place, publisher, year, edition, pages
2017. , p. 48
Keywords [en]
AstraZeneca, Microcrystalline cellulose, MUPS, Moisture content, Particle size, Drug release, Controlled release, Release profile, Full factorial design, Design of Experiment
National Category
Chemical Sciences
Identifiers
URN: urn:nbn:se:liu:diva-134431ISRN: LITH-IFM-A-EX—17/3288—SEOAI: oai:DiVA.org:liu-134431DiVA, id: diva2:1073716
External cooperation
AstraZeneca
Subject / course
Chemical Biology
Presentation
2017-01-27, Linköping, 11:02 (Swedish)
Supervisors
Examiners
Available from: 2017-02-13 Created: 2017-02-13 Last updated: 2017-12-18Bibliographically approved

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