Formulation development, optimization and characterization of mucoadhesive minitablets of cefuroxime axetil: in vitro, ex vivo and in vivo pharmacokinetic evaluation

Abstract Background The current study expands on the use of design experiment in developing cefuroxime axetil mucoadhesive minitablets for treating antibiotic-associated colitis. A comprehensive QbD-based product development strategy was implemented, with target profile defined based desired quality minitablets. identified critical attributes are profile. goal to find optimum levels by using concentrations chitosan (mg) (X1), HPMC K100M (X2) and sodium carboxymethyl cellulose (X3) as influential variables. response surface methodology determines dependent variables 3 Box–Behnken optimize selected factors. friability (%), drug content (%) strength characteristics were evaluated ANOVA observed responses or Results demonstrated that run 8 composition chitosan, carboxy methyl cellulose, which polymers, showed a desirable promising release up 24 h, higher percentage content, mucoadhesion swelling index. Conclusions optimized formulation characteristics, including improved bioavailability high control over drug’s rate increased flexibility adjusting both dose rate. In nutshell, studies support successful axetil, could be used treat