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Assessing the use of twin screw wet granulation in a multi stage manufacturing process for the continuous production of pharmaceutical products
| Content Provider | Semantic Scholar |
|---|---|
| Author | Holman, James William |
| Copyright Year | 2013 |
| Abstract | James Holman Page 3 of 228 Abstract Traditionally pharmaceutical manufacture is conducted on a batch basis but significant resources are being invested into the use of intensified continuous processes. This dissertation evaluates the use of a combined twin screw and segmented fluid bed drying process to produce granules on a continuous basis. The experimental program was conducted using structured Design of Experiments in three stages. Wet granulation only: Investigated the initial relationships between liquid/solid ratio and power required for wet granulation, as well as granule structure using SEM imaging. Wet granulation and fluid bed drying: Concluded that the biggest control over the measured mean granule size (d50) produced from the combined system was still the ratio of water to dry powder in the wet granulation. Wet granulation through to compression: The effects of changes in the granulation process were not statically relevant on the final tablet for the process set up. The study also used PEPT data to assess motion within the TSG. The studies showed: The time spent in the kneading zone directly after the liquid addition in relation to the overall time spent in the granulation process appears independent of the process set up at 32% ± 2%. As the barrel speed of the granulator increases the relative time spent in the final ‘breakage zone’ of the TSG increases, therefore increasing breakage. Using the findings from the literature, the results of the experimental program were used to define the mechanisms occurring within the TSG. The experimental findings were input into a model to predict the outcome of collisions between particles. The model predicts agglomeration of the smaller particles to the larger ones and by calculating changes in the viscosity of the binder the subsequent secondary agglomeration of these granules can also be shown using this model. The model is limited due to assumptions in deriving it. The model excludes capillary forces that if given sufficient time to form could have the same order of magnitude strength as other forces. Abstract University of SurreyUniversity of Surrey James Holman Page 4 of 228 Acknowledgements I would like to give special thanks to: Dr Frank Roche, GSK (Project Sponsor). Dr Jamie Cleaver, University of Surrey. Prof Rex Thorpe, University of Surrey. Dr Dave Seaward, 3 P Innovation. Mr Trevor Page, GEA Pharma systems. Mrs Dee Dee Holman. Mr and Mrs. W Holman For all the other countless people that have helped me along this long journey: “I can no other answer make, but, thanks, and thanks” William Shakespeare. |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | http://epubs.surrey.ac.uk/807047/1/J%20Holman%20Thesis%20Final.pdf |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
