BOX–BEHNKEN DESIGN-DRIVEN FORMULATION AND EVALUATION OF A NOVEL TOPICAL GEL CONTAINING CEFEPIME HCL AND L-ARGININE
DOI:
https://doi.org/10.22159/ajpcr.2025v18i9.55469Keywords:
Cefepime hydrochloride, L-arginine, Topical gel formulation, Box–Behnken design, Antibacterial gel, In vitro drug release, Agar welldiffusion method, Franz diffusion cell, Spreadability, Viscosity evaluation, Design-Expert® softwareAbstract
Objective: The present study aims to develop and optimize an antibacterial gel formulation containing Cefepime HCl and L-Arginine using a Box– Behnken design, with a focus on sustained drug release and improved antibacterial activity.
Methods: The gel was prepared using Carbopol 940 as the gelling agent, and pH was adjusted to neutrality using sodium hydroxide. Polyethylene glycol, glycerol, butylated hydroxytoluene, and methylparaben were included as excipients. A 32 factorial design was employed to evaluate the influence of Carbopol concentration and stirring time on drug release characteristics. The formulations were assessed for pH, viscosity, spreadability, extrudability, and drug content uniformity. In vitro drug release was studied using a Franz diffusion cell, and antimicrobial activity was evaluated against Staphylococcus aureus and Pseudomonas aeruginosa using the agar well-diffusion method.
Results: Formulation F5 demonstrated optimal physicochemical and rheological properties, with sustained biphasic drug release reaching 98% over 12 h. Drug content uniformity ranged from 53.9% to 104.6% across batches. The formulation exhibited moderate antibacterial activity against S. aureus and weak activity against P. aeruginosa, with maximum inhibition observed at 1000 μg.
Conclusion: The optimized Cefepime HCl–L-Arginine gel (F5) exhibited desirable drug release and acceptable physicochemical characteristics. Although antimicrobial efficacy was moderate, particularly against Gram-positive strains, further modification may enhance its activity against resistant pathogens.
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