A STUDY ON PROCESS DRIFT OF DIRECTLY COMPRESSIBLE MATRIX TABLETS OF ISONIAZID

Surendra Agrawal*, Pratushti Mittal and Shishupal Bodhankar

ABSTRACT

Solid oral dosage forms are the preferred route for many drugs and are still the most widely used formulations. Of these, tablets offer the lowest cost approach. Matrix tablets serves as an important tool for oral dosage forms. Pharmaceutical industry engaged in making solid dosage form is facing critical problems in proving their process reproducibility. Even that has reduced profits, especially because of critical deviations which are consequences of continuous process and inadequate research. Up-scaling can be challenging as minor changes in parameters can lead to varying quality results. The main objective of the work was to select critical process parameters (CPP) using retrospective data of a developed product and to establish a design of experiments (DoE) that would improve the robustness of the tableting process. Batches were selected based on the quality results generated during batch release, some of which revealed quality deviations concerning the appearance of the coated tablets. The Minitab 17 software was used for data processing to determine critical process parameters in order to propose new working ranges. This study confirms that it is possible to determine the critical process parameters and create design spaces based on retrospective data of production batches. This type of analysis is thus converted into a tool to optimize the robustness of existing processes. This study will help to determine a design space which can be established with minimum investment in experiments.

Keywords: Direct compression, Formulation variables, Process variables, matrix tablets, Isoniazid.