Design and evaluation of a novel formulation prediction system.

PURPOSE

The purpose of this study is to design and evaluate a novel formulation prediction system for formulation study of monolithic osmotic pump tablets (MOPTs).

METHODS

Ternary-component diagram was originally brought forward to evaluate MOPTs formulations. Optimal formulation regions were delimited in ternary-component diagrams. Water-insoluble drug gliclazide was chosen as a model drug for selecting most suitable suspending agent. With five model drugs, we obtained five ternary-component diagrams. By MATLAB(®) software, a triangular prism model was then established regarding doses as vertical coordinate and the five diagrams as cross-sections, with the formation of an optimal formulation channel in it, followed by the design of formulation prediction software (FPS 1.0). The practicality of the system was finally validated.

RESULTS

After entering the drug information, we immediately obtained the optimal formulation region for preparing MOPTs with interpolation algorithm. The dissolution test results of the four randomly selected formulations all met the evaluating conditions.

CONCLUSIONS

Ternary-component diagram is useful for MOPTs formulation optimization. The predictive ability of the system is tentatively confirmed and the experiment efficiency is greatly improved.