Formulation development, optimization, and evaluation of fast-dispersing tablets of cefixime trihydrate for pediatric use

The proposed study aimed to formulate and optimize the design of a fast-dispersing tablet (FDT) of cefixime trihydrate (dispersed in a teaspoon of water) tailored for pediatric patients (0–12 years). To assess the percentage concentration of the cefixime in the formulated tablets, the HPLC method was validated and established linearity, r² = 0.9998 in the range of 20–0.078 µg/mL. The preformulation study was carried out. Crospovidone (X1), croscarmellose sodium (X2), and sodium starch glycolate (X3) were selected as key independent variables, and their impact was executed on friability and disintegration time as dependent variables. Central composite design (2 3 ) optimized the process using eight formulations (F1–F8) with different X1, X2, and X3 concentrations. F2 and F9 (additional, similar to F2) were selected as checkpoint batches (CPB) using Design Expert software. Stability studies of CPB were conducted. The study concluded that the newly formulated tablets could be optimized quickly, with their drug release and absorption profiles resembling those of the marketed suspension. Additionally, the tablets were found to be a viable alternative to the suspension.