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Volume 94
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Review

Current Challenges and Approaches to the Development of Novel Drug Products for Otic Administration: A Narrative Review

by
Elena O. Bakhrushina
1,*,
Natalia N. Mikhailova
1,
Anastasia N. Golub
1,
Ksenia V. Eremeeva
2,
Anna-Daniela Koynova
1,*,
Anna A. Popova
3,
Andrey B. Goryachev
4,
Olga I. Stepanova
5,
Ivan I. Krasnyuk, Jr.
6 and
Ivan I. Krasnyuk
1
1
Department of Pharmaceutical Technology, A. P. Nelyubin Institute of Pharmacy, I. M. Sechenov First Moscow State Medical University (Sechenov University), 119571 Moscow, Russia
2
Department of Ear, Nose and Throat Diseases, N.V. Sklifosovskiy Institute of Clinical Medicine, I. M. Sechenov First Moscow State Medical University (Sechenov University), 119021 Moscow, Russia
3
Department of Biotechnology, A. P. Nelyubin Institute of Pharmacy, I. M. Sechenov First Moscow State Medical University (Sechenov University), 119571 Moscow, Russia
4
Department of Life Safety and Disaster Medicine, N.V. Sklifosovskiy Institute of Clinical Medicine, I. M. Sechenov First Moscow State Medical University (Sechenov University), 119021 Moscow, Russia
5
Department of Pharmacology, A. P. Nelyubin Institute of Pharmacy, I. M. Sechenov First Moscow State Medical University (Sechenov University), 119571 Moscow, Russia
6
Department of Analytical, Physical and Colloidal Chemistry, A. P. Nelyubin Institute of Pharmacy, I. M. Sechenov First Moscow State Medical University (Sechenov University), 119571 Moscow, Russia
*
Authors to whom correspondence should be addressed.
Sci. Pharm. 2026, 94(3), 55; https://doi.org/10.3390/scipharm94030055 (registering DOI)
Submission received: 26 April 2026 / Revised: 27 June 2026 / Accepted: 30 June 2026 / Published: 5 July 2026
Versions Notes

Abstract

Acute otitis media is an inflammatory disease affecting all compartments of the middle ear, characterized by localized pain, fever, hearing impairment, and, occasionally, purulent exudate. It represents a significant clinical concern in both pediatric and adult populations, with approximately 709 million cases reported annually worldwide, 51% of which occur in children. However, currently available topical otic formulations are limited by their inability to achieve predictable therapeutic concentrations at the site of inflammation, resulting in reduced efficacy. In addition, the selection of appropriate active pharmaceutical ingredients (APIs) for drug products remains challenging; as a result, existing therapies do not comprehensively address all stages of pathogenesis. This study aimed to analyze existing locally acting formulations for middle ear drug delivery, evaluate their advantages and limitations, and assess modern approaches to the development of novel drug delivery systems and API combinations. A critical review of 69 publications (2010–2026) was conducted, supplemented by a strengths and limitations analysis of dosage forms and an evaluation of APIs based on clinical data. The findings highlight a lack of targeted drug delivery systems, limited efficacy of existing API combinations against bacterial biofilms, and their risk of ototoxicity. Emerging innovative drug delivery approaches, including microemulsions, vesicular systems, stimuli-responsive systems, and hydrogels, have demonstrated promising results in preclinical studies; however, their efficacy and safety remain to be confirmed in clinical settings before their full therapeutic potential in otitis media treatment can be realized.
Keywords: acute otitis; chronic otitis; topical administration; transtympanic drug delivery; vesicular systems; nano- and microemulsions; stimuli-responsive hydrogels; absorption enhancers; permeation enhancers acute otitis; chronic otitis; topical administration; transtympanic drug delivery; vesicular systems; nano- and microemulsions; stimuli-responsive hydrogels; absorption enhancers; permeation enhancers

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MDPI and ACS Style

Bakhrushina, E.O.; Mikhailova, N.N.; Golub, A.N.; Eremeeva, K.V.; Koynova, A.-D.; Popova, A.A.; Goryachev, A.B.; Stepanova, O.I.; Krasnyuk, I.I., Jr.; Krasnyuk, I.I. Current Challenges and Approaches to the Development of Novel Drug Products for Otic Administration: A Narrative Review. Sci. Pharm. 2026, 94, 55. https://doi.org/10.3390/scipharm94030055

AMA Style

Bakhrushina EO, Mikhailova NN, Golub AN, Eremeeva KV, Koynova A-D, Popova AA, Goryachev AB, Stepanova OI, Krasnyuk II Jr., Krasnyuk II. Current Challenges and Approaches to the Development of Novel Drug Products for Otic Administration: A Narrative Review. Scientia Pharmaceutica. 2026; 94(3):55. https://doi.org/10.3390/scipharm94030055

Chicago/Turabian Style

Bakhrushina, Elena O., Natalia N. Mikhailova, Anastasia N. Golub, Ksenia V. Eremeeva, Anna-Daniela Koynova, Anna A. Popova, Andrey B. Goryachev, Olga I. Stepanova, Ivan I. Krasnyuk, Jr., and Ivan I. Krasnyuk. 2026. "Current Challenges and Approaches to the Development of Novel Drug Products for Otic Administration: A Narrative Review" Scientia Pharmaceutica 94, no. 3: 55. https://doi.org/10.3390/scipharm94030055

APA Style

Bakhrushina, E. O., Mikhailova, N. N., Golub, A. N., Eremeeva, K. V., Koynova, A.-D., Popova, A. A., Goryachev, A. B., Stepanova, O. I., Krasnyuk, I. I., Jr., & Krasnyuk, I. I. (2026). Current Challenges and Approaches to the Development of Novel Drug Products for Otic Administration: A Narrative Review. Scientia Pharmaceutica, 94(3), 55. https://doi.org/10.3390/scipharm94030055

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