| The development of predictive mathematical models is desirable for pharmaceutical formulation than a long process of trial and errors to adjust the formulation. The predictive models for the pharmaceutical process is not only of great importance to formulation aspect but also important in context of the quality by design concept. The purpose of this study is to predict the tensile strength of the multi-component tablet system based on the material properties of individual component system such as tensile strength zero porosity (sigma oT), bonding capacity (kT), tensile strength at solid fraction 1 (sigmaoP), and fracture component (TfT). Two mathematical modeling approaches were investigated namely: Ryshkewitch-Duckworth (RD) and Percolation Theory (PT) model to predict the tensile strength for multi-component systems. Six commonly used excipients of different deformation property were selected, namely: Microcrystalline PH 102 (plastic), Lactose Anhydrous (Fragmentation), Pregelatinized Starch (Visco-elastic), Dicalcium Dihydrate (Fragmentation) and Soluplus (Plastic). Various multi-component systems- ternary, quaternary, quinary and senary component systems were prepared by mixing the selected excipients. Nine different combinations of linear, power and log mixing rule were used to calculate material parameters for the multi-compacted systems. The calculated material parameters were applied to the mathematical models to predict the mechanical strength of the multi-component system. Statistical tools like residual sum square (RSSQ) and Akaike's Information Criterion (AIC) were used to compare and choose the best mixing rule among nine different mixing rules that gave the best prediction. Results showed that various mixing rules were able to successfully predict the tensile strength for multi-component systems using both the mathematical models. |
