For all types of drugs and clinical trials in the drug development process, the use of non-clinical models and relevant animal species is essential to obtain predictive data for humans. Sensorineural hearing loss is a condition that manifests clinically through perceptual hearing impairment. Fixed-dose combinations have advanced in many therapeutic areas, including inner ear pathology, where hearing disorders and balance are increasingly prevalent. Within the Scientific Center of Medicines, a fixed-dose combinations medicinal product was developed with potential efficacy in the treatment of vestibulo-cochlear disorders. This product containing capsules of Nicergoline, Piracetam, and Hawthorn Extract.
The presented national project (no. 20.80012.8007.02SE, 2024-25) proposes streamlining preclinical research methods for medicinal products acting on the auditory and vestibular system in accordance with current requirements of experimental modeling for laboratory animals. All procedures describing experiments involving laboratory animals were conducted in accordance with Directive 2010/63/EU and national Law no. 211/2017. The research algorithm consists of: establishing the method for inducing sensorineural hearing loss and peripheral vestibulopathy; experimental audiometric methods (otoacoustic emissions, Preyer reflex) for monitoring sensorineural hearing loss; preclinical testing of static and dynamic locomotor coordination in Wistar rats (open field test, horizontal walking, and forced motor activity test to maintain balance).
Preclinical research in the fields of audiology and experimental vestibulometry demonstrated the beneficial effect of the studied product in the complex treatment of sensorineural hearing loss and peripheral vestibular disorders. The combination therapy yielded the most significant benefits, with no notable side effects observed. Considering the complex etiology and multifactorial pathophysiology of these conditions, the development of combination therapies is of growing interest.
Has been developed a practical basis for an interdisciplinary and systemic conceptual approach of preclinical studies on the development, pharmacological treatment of sensorineural hearing loss and vestibulopathy. The expected result of the study is the development of a new methods and optimizing existing methods for experimental modeling of inner ear diseases and balance disorders. The novelty of the project involves measuring the effectiveness audiometric and vestibulometric preclinical researches of sensorineural hearing loss and peripheral vestibulopaty.
Keywords: otoacoustic emissions, fixed-dose combined medicinal product, preclinical research, sensorineural hearing loss, vestibular disorders
Citation: PARII, S. et al. (2025). Preclinical Research Optimization of Medicinal Products with Action of the Inner Ear. J Medical Case Repo 7(4):1-4. DOI : https://doi.org/10.47485/2767-5416.1137