Application of Multivariate Methods to Evaluate Differential Material Attributes of HPMC from Different Sources.

The aim of the present study is to achieve differential material attributes (DMAs) of hydroxypropyl methylcellulose (HPMC) with different viscosity grades (K4M, K15M, and K100M) from different manufacturers (Anhui Shanhe and Dow Chemical). Two kinds of multivariate methods, principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA), were adopted. The physicochemical properties of HPMC were systematically investigated via various techniques (e.g., SEM, particle size detection, and SeDeM characterization). Data from 33 characterization variables were applied to the multivariate methods. The PCA and OPLS-DA results indicated the differences between the HPMC from two manufacturers by the common variables that include the tablet hardness (HD), tensile strength (TS), bulk density, interparticle porosity, Carr index, cohesion index, Hausner ratio, flowability, and the width of the particle size distribution (span). Interestingly, these variables showed a certain correlation with each other, supporting the characterization results. Except for these different variables of the HPMC obtained by multivariate analysis results, distinguishable shapes and surface morphologies also appeared between different sources. To sum up, the powder properties (particle size, surface topography, dimension, flowability, and compressibility) and the tablet properties (HD and TS) were recognized as the DMAs of HPMC samples. This work provided the multivariate methods for the physicochemical characterization of HPMC, with potential in the quality control and formulation development.