Development of a Natural Preservative System in Fluticasone Propionate Nasal Spray Formulation Using Eucalyptus globulus Essential Oil

Background: Replacing all or part of synthetic preservatives with natural antimicrobials in pharmaceutical formulations can be a way to improve the safety and quality products. Evaluating preservative effectiveness essential oils is valuable since most them are generally known safe. Objectives: In current research, efficacy Eucalyptus globulus oil was investigated as an antimicrobial agent individually combination benzalkonium chloride fluticasone propionate nasal spray. Methods: To determine minimum inhibitory concentration (MIC) E. oil, vitro activity assayed. The stability sprays studied intended preservation conditions at 40°C RH: 25 %, also microbial challenge test performed according United States Pharmacopoeia procedure, using reference strains: Staphylococcus aureus ATCC 1112, Escherichia coli 1330, Pseudomonas aeruginosa 1074, Candida albicans 5027, Aspergillus brasiliensis 5011. Results: combined application 0.675/0.005% v/v, spray formulation could decrease bacterial fungal populations, compliance criteria, considerable within 28 days study compared those preserved only (0.02%). Conclusions: notable combinational system observed followed by functional level preservative. Therefore, after further studies, considered alternative for formulations.