Robustness Testing of a Tablet Formulation Using Multivariate Design - Excipients

Robustness Testing of a Tablet Formulation Using Multivariate Design
2006
Jon Gabrielsson A1, Michael Sjàstràm A1, Nils-Olof Lindberg A2, Ann-Christin Pihl A2, Torbjàrn Lundstedt A3
Drug Development and Industrial Pharmacy
Publisher: Taylor & Francis
Issue: Volume 32, Number 3
A1 Research Group for Chemometrics, Department of Chemistry, Ume¬ University, Ume¬, Sweden
A2 Pharmacia AB, Consumer Healthcare, Helsingborg, Sweden
A3 Department of Medicinal Chemistry, Uppsala University, Uppsala, Sweden
Abstract:
A total of 45 experiments were carried out to evaluate the robustness of two similar tablet formulationsÛa product of two strengthsÛwith respect to normal batch-to-batch variation of the excipients and the active pharmaceutical ingredient. The formulations consist of 10 ingredients. Because of the differing amounts of active pharmaceutical ingredients, the two formulations also differ in the amounts of two of the diluents and one of the binders. The excipients and active pharmaceutical ingredient were characterized in terms of multiple variables, and principal properties were calculated with principal component analysis. A Plackett and Burman design was applied to the principal properties. The relationships between the design factors and two responses, mean disintegration time and mean crushing strength, were evaluated by using regression methods. Both formulations were found to be robust under controlled conditions.
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Keywords:
Robustness testing, Plackett-Burman design, multivariate design, PCA, PLS
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