Abstract：
:The implementation of a blend monitoring and control method based on a process analytical technology such as near infrared spectroscopy requires the selection and optimization of numerous criteria that will affect the monitoring outputs and expected blend end-point. Using a five component formulation, the present article contrasts the modeling strategies and end-point determination of a traditional quantitative method based on the prediction of the blend parameters employing partial least-squares regression with a qualitative strategy based on principal component analysis and Hotelling's T(2) and residual distance to the model, called Prototype. The possibility to monitor and control blend homogeneity with multivariate curve resolution was also assessed. The implementation of the above methods in the presence of designed experiments (with variation of the amount of active ingredient and excipients) and with normal operating condition samples (nominal concentrations of the active ingredient and excipients) was tested. The impact of criteria used to stop the blends (related to precision and/or accuracy) was assessed. Results demonstrated that while all methods showed similarities in their outputs, some approaches were preferred for decision making. The selectivity of regression based methods was also contrasted with the capacity of qualitative methods to determine the homogeneity of the entire formulation.
journal_name
Int J Pharmjournal_title
International journal of pharmaceuticsauthors
Igne B,de Juan A,Jaumot J,Lallemand J,Preys S,Drennen JK,Anderson CAdoi
10.1016/j.ijpharm.2014.06.061subject
Has Abstractpub_date
2014-10-01 00:00:00pages
219-31issue
1-2eissn
0378-5173issn
1873-3476pii
S0378-5173(14)00498-0journal_volume
473pub_type
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