MICROBIOLOGICAL SUBSTANTIATION OF THE COMPOSITION OF COMBINED EAR DROPS «TYMP» FOR THE TREATMENT OF OTITIS WITH TYMPANIC MEMBRANE PERFORATION

Abstract

Aim. To substantiate the qualitative and quantitative composition of safe ear drops for the treatment of acute and chronic otitis media with tympanic membrane perforation based on local microbiological monitoring.

Material and methods. A retrospective bacteriological analysis of ear discharge from 55 patients with verified perforative otitis media (Belgorod region, 2021–2022) was performed. Microorganisms were identified by MALDI-TOF mass spectrometry; antibiotic susceptibility was determined by the disk diffusion method according to EUCAST (2021). The antimicrobial activity of the proposed combination (ciprofloxacin hydrochloride 0.5%, BDAHM 0.01%, ketoprofen lysine salt 0.5%) was assessed by the agar well diffusion method. Physicochemical parameters of the solution (pH, viscosity) were additionally studied.

Result. The leading pathogens were Pseudomonas aeruginosa (69.1%), Proteus mirabilis (52.7%), and Streptococcus pneumoniae (43.6%); microbial associations were identified in 44% of cases. High resistance rates were observed for ampicillin (60%), amoxicillin/clavulanate (45%), and gentamicin (38%). Model mixture No. 2 showed 100% susceptibility (S) to all six priority pathogens (inhibition zones 22–26 mm). Based on microbiological data, the composition of «Tymp» drops was proposed, including ciprofloxacin 0.5%, BDAHM 0.01%, ketoprofen lysine salt 0.5%, sodium hyaluronate 0.1%, carbomer 0.05%, and water for injection (pH 7.8). The formulation is free of alcohol, aminoglycosides, and local anesthetics.

Conclusion. The obtained microbiological profile and the proven in vitro activity of the fluoroquinolone–cationic antiseptic combination allow recommending the developed composition as a safe alternative for topical therapy of perforative otitis, filling a critical gap in the Russian pharmaceutical market.