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Novel description of a design space for fluidised bed granulation.
Int J Pharm. 2007 Dec 10; 345(1-2):101-7.IJ

Abstract

The physical measurements of a fluid bed granulator can be exploited in construction of an operating window, a design space, for process performance. The purpose of this study was to determine the influence of inlet air humidity changes on temperature in different parts of a granulator system, on fluidisation behaviour and on the particle size of the final granules. A humidifying setup was constructed on a bench-scale fluid bed granulator that enabled elevated humidity levels and sharp humidity changes of the inlet air. Ibuprofen granules were produced at the various inlet air humidity levels classified as low, intermediate and high. A novel fluidisation parameter was developed. The more improperly the particles were fluidising the smaller was the relationship of airflow rate and fan speed. Four different failure modes were identified and classified, based on the fluidisation parameter: over-fluidisation, risk of improper fluidisation, improper fluidisation and collapsed bed. It was possible to construct process trajectories for smooth fluidisation, which the optimal granulation process should follow.

Authors+Show Affiliations

Orion Corporation Orion Pharma, Orionintie 1, P.O. Box 65, FIN-02101 Espoo, Finland. tanja.lipsanen@orionpharma.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17616286

Citation

Lipsanen, Tanja, et al. "Novel Description of a Design Space for Fluidised Bed Granulation." International Journal of Pharmaceutics, vol. 345, no. 1-2, 2007, pp. 101-7.
Lipsanen T, Antikainen O, Räikkönen H, et al. Novel description of a design space for fluidised bed granulation. Int J Pharm. 2007;345(1-2):101-7.
Lipsanen, T., Antikainen, O., Räikkönen, H., Airaksinen, S., & Yliruusi, J. (2007). Novel description of a design space for fluidised bed granulation. International Journal of Pharmaceutics, 345(1-2), 101-7.
Lipsanen T, et al. Novel Description of a Design Space for Fluidised Bed Granulation. Int J Pharm. 2007 Dec 10;345(1-2):101-7. PubMed PMID: 17616286.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Novel description of a design space for fluidised bed granulation. AU - Lipsanen,Tanja, AU - Antikainen,Osmo, AU - Räikkönen,Heikki, AU - Airaksinen,Sari, AU - Yliruusi,Jouko, Y1 - 2007/05/29/ PY - 2007/03/25/received PY - 2007/05/23/accepted PY - 2007/7/10/pubmed PY - 2008/1/25/medline PY - 2007/7/10/entrez SP - 101 EP - 7 JF - International journal of pharmaceutics JO - Int J Pharm VL - 345 IS - 1-2 N2 - The physical measurements of a fluid bed granulator can be exploited in construction of an operating window, a design space, for process performance. The purpose of this study was to determine the influence of inlet air humidity changes on temperature in different parts of a granulator system, on fluidisation behaviour and on the particle size of the final granules. A humidifying setup was constructed on a bench-scale fluid bed granulator that enabled elevated humidity levels and sharp humidity changes of the inlet air. Ibuprofen granules were produced at the various inlet air humidity levels classified as low, intermediate and high. A novel fluidisation parameter was developed. The more improperly the particles were fluidising the smaller was the relationship of airflow rate and fan speed. Four different failure modes were identified and classified, based on the fluidisation parameter: over-fluidisation, risk of improper fluidisation, improper fluidisation and collapsed bed. It was possible to construct process trajectories for smooth fluidisation, which the optimal granulation process should follow. SN - 0378-5173 UR - https://www.unboundmedicine.com/medline/citation/17616286/Novel_description_of_a_design_space_for_fluidised_bed_granulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(07)00474-7 DB - PRIME DP - Unbound Medicine ER -