(507c) Impact of Physico-Mechanical Properties of Co-Processed Excipients on the Tableting Performance By DM3 Approach

The aim of present investigation was to evaluate tableting performance of co-processed excipients (CPEs) MicroceLac® 100, StarLac® and CombiLac® at different humidity conditions using our previously published DM3 approach. The DM3 approach involves the design of experiments (D) and multivariate analysis techniques (M3) to determine the effect of material properties (M1), and manufacturing factors (M2) on product attributes like compressibility, compactibility, and tabletability. The powders were exposed at different relative humidities of 33.0 % ± 1.4 % RH, 55.0 % ± 4.8 % RH, 75.0 % ± 4.3 % RH. These exposed powders were compressed at 5mm/minute compression speed and at 100 MPa compression pressure using bench-top compaction simulator. The evaluated material properties were sorption-desorption behavior, equilibrium moisture content (%), enthalpy of dehydration and crystallization, and heat of fusion. The compression properties were modeled with ‘in-die’ Heckel descriptors. The material and manufacturing factors together were used to study impact on the compressibility, compactibility and tabletability of these materials. Multivariate Analysis of Variance (MANOVA), Principal Component Analysis (PCA), and Principal Component Regression (PCR) were the statistical tools used to analyze the data. Increased moisture content gave a significant reduction in TMS. On the other hand, the reduced tablet porosity indicated increased compressibility. The Heckel analysis showed a reduction in YPpl (MPa) and YPel (MPa) values indicating increased plastic deformation and elastic recovery. Reduction in WoC and WoE was also observed on increasing humidity levels. It seems that the spray dried co-processed excipients sorbed moisture on exposing at increasing humidities. The lubricating and plasticizing effect of moisture caused an increase in compressibility. However, the moisture caused weakening of interparticular bonds and decreased particle-particle interaction thereby decreasing the TMS. Thus, present investigation can be utilized for a careful selection of CPEs in the formulation.