Imperial College London
Professor Pantelides

Professor Pantelides

Faculty of Engineering, Department of Chemical Engineering

Professor
 
 
 
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Contact

 

+44 (0)20 7594 5622c.pantelides

 
 
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Location

 

C401Roderic Hill BuildingSouth Kensington Campus

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Summary

 

Publications

Citation

BibTex format

@article{García:2016:10.1016/j.cherd.2016.03.005,
author = {García, Muñoz S and Yu, W and Pantelides, CC},
doi = {10.1016/j.cherd.2016.03.005},
journal = {Chemical Engineering Research and Design},
pages = {532--539},
title = {SimCU: A new model to assess content uniformity of oral dosages based on particulate mass balances and Monte Carlo simulations},
url = {http://dx.doi.org/10.1016/j.cherd.2016.03.005},
volume = {109},
year = {2016}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - A new model (SimCU) is presented to assess the risk of failure on content uniformity for oral dosage forms. The proposed model is an extension to the algorithm presented by Zhang and Johnson (Int. J. Pharm. 1997;154:179-183), including a revision needed to prevent artificial loss of drug and segregation. Furthermore, the improved approach is extended to enable the user to consider alternate sources of variability such as the weight distribution of the dosage forms and the effect of a drug product intermediate (i.e., a granule) with heterogeneous potency levels across particle sizes. The particle mass balance in the corrected algorithm is consistent and its closed form solution for the prediction of the relative standard deviation of potency is presented herein. Predictions of the relative standard deviation (RSD) from SimCU were extensively verified with data from development, clinical and commercial manufacture. Such results support the usage of the proposed model to assess the risk of failure for content uniformity for oral dosage forms which will ultimately drive the specifications for particle size distribution of the drug.
AU  - García,Muñoz S
AU  - Yu,W
AU  - Pantelides,CC
DO  - 10.1016/j.cherd.2016.03.005
EP  - 539
PY  - 2016///
SN  - 0263-8762
SP  - 532
TI  - SimCU: A new model to assess content uniformity of oral dosages based on particulate mass balances and Monte Carlo simulations
T2  - Chemical Engineering Research and Design
UR  - http://dx.doi.org/10.1016/j.cherd.2016.03.005
VL  - 109
ER  -
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