title: Multivariate methods in the development of a new tablet formulation: optimization and validation.
abstract: In a previous study of the development of a tablet formulation approximately 100 excipients were characterized in screening experiments using multivariate design. Acceptable values for important responses were obtained with some of the formulations. The relationships between the properties of the excipients and the responses were evaluated using PLS. In this study additional experiments were performed in order to validate models obtained from the screening study and to find a formulation of suitable composition with desired tablet properties. A formulation with the desired disintegration time was found with the additional experiments and the agreement between observed and predicted values was fair for the tablets that did disintegrate. A limitation of this study was that tablets from four experiments did not disintegrate within the set time limit. The lack of agreement between observed and predicted values of these four experiments was probably due to the nature of one of the factors in the design. Considering the reduced experimental design the results are still encouraging.
authors.affiliation: Research Group for Chemometrics, Department of Chemistry, Umeå University, Umeå, Sweden.
authors.forename: Jon
authors.initials: J
authors.lastname: Gabrielsson
authors.forename: Nils-Olof
authors.initials: NO
authors.lastname: Lindberg
authors.forename: Magnus
authors.initials: M
authors.lastname: Pålsson
authors.forename: Fredrik
authors.initials: F
authors.lastname: Nicklasson
authors.forename: Michael
authors.initials: M
authors.lastname: Sjöström
authors.forename: Torbjörn
authors.initials: T
authors.lastname: Lundstedt
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D005079:Excipients / Q000737:chemistry / Q000493:pharmacokinetics; D015999:Multivariate Analysis; D015203:Reproducibility of Results; D013607:Tablets / Q000737:chemistry* / Q000493:pharmacokinetics; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D005079:Excipients; D013607:Tablets