Robustness testing of a tablet formulation using multivariate design.
A total of 45 experiments were carried out to evaluate the robustness of two similar tablet formulations--a product of two strengths--with 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.
Gabrielsson
Jon
J
Research Group for Chemometrics, Department of Chemistry, Umeå University, Umeå, Sweden.
Sjöström
Michael
M
Lindberg
Nils-Olof
NO
Pihl
Ann-Christin
AC
Lundstedt
Torbjörn
T
D002626:Chemistry, Pharmaceutical / Q000706:statistics & numerical data*; D019245:Compressive Strength; D005079:Excipients / Q000737:chemistry*; D015999:Multivariate Analysis; D015203:Reproducibility of Results; D013607:Tablets / Q000737:chemistry*; D014867:Water / Q000737:chemistry
D005079:Excipients; D013607:Tablets; D014867:Water