Development of directly compressible polyherbal tablets by using QbD approach a novel immunomodulatory material

Abstract

A Quality by Design (QbD) strategy was used to develop and optimise a polyherbal tablet formulation in this study. Initial risk assessments of critical materials were conducted using the Risk Priority Number, and the effects of critical parameters (amount of microcrystalline cellulose and croscarmellose sodium) were proposed using a randomised complete factorial design. To further the findings, a Design of Experiments (DoE) approach was used to formulate four trial formulations, with independent variables of microcrystalline cellulose (MCC) 5 % -15 % and croscarmellose sodium (CCS) 0.5 % -5 %, and responses measured in friability and disintegration time, which were found to be 0.35–0.91 % and 11.4–15.5 minutes, respectively. Three formulations (F-1, F-2, and F-4) fulfilled the acceptable criteria and one formulation (F-1) had independent variables microcrystalline cellulose and croscarmellose sodium, out of four formulation trials (F-1 to F-4) were chosen for short-term stability study due to their better disintegration and friability profiles. The formulation factors X1: microcrystalline cellulose and X2: croscarmellose sodium were found to have a substantial impact on the responses Y1: Disintegration time (min) and Y2: Friability (%). This study proved that using quality by design to analyse quality characteristics and optimise polyherbal tablet formulation gives better results.