An Investigation through the Pharmacotechnical Factors-to Develop a Method to Replace a Super Disintegrant in an Immediate Release Tablet

Abstract

Objectives: The present work aim to identify the process parameters and technical parameters of granules that affect the disintegration time of an IR tablet. There by utilizing this knowledge to develop an IR tablet without any Super Disintegrants (SD). Methods: The experiments were designed using Design-Expert^®. A two factorial design at two levels (-1, + 1) were selected. The study evaluated the effect of particle size and Binder concentration (BC) on Disintegration Time (DT), Hardness and Compressibility index (CI). Discussion: The CI below 16% can be achieved for the granules prepared with particle size > 670μ m and binder concentration> 18.56mg for PVP K 30. The particle sizes do not possess any impact on disintegration time. The granules prepared at the 250μ size and 600μ size shoes similar disintegration time. However, the particle size affects hardness and CI. The BC has a strong impact on hardness, CI and DT. Even though the particle size does not have a direct impact on DT, it affects the hardness, which has a greater impact on DT. Conclusion: The study identified the technical methods and suggests certain formula to attain the low disintegration time, excellent hardness for an IR tablet and fair flow property for the prepared granules. The particle size has a direct impact on the hardness of the tablet. The formula serves as an excellent alternative for SD at an industrial level, to make the drug product more economical and more effective.