Terbinafine hydrochloride — a drug with a wide range of antifugal protection

Mardanly S.G.; Rogozhnikova E.P.; Rogozhnikov J.A.

doi:https://doi.org/10.17116/klinderma202322061693

Mardanly S.G.

CJSC «EKOlab»;
State University of Humanities and Technology

ORCID: 0000-0003-3650-2363

Rogozhnikova E.P.

CJSC «EKOlab»;
State University of Humanities and Technology

ORCID: 0000-0002-8725-4673

Rogozhnikov J.A.

Military Academy of Radiation, Chemical and Biological Protection named after Marshal of the Soviet Union S.K. Timoshenko

ORCID: 0009-0006-0966-0912

Terbinafine hydrochloride — a drug with a wide range of antifugal protection

Authors:

Mardanly S.G., Rogozhnikova E.P., Rogozhnikov J.A.

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Journal: Russian Journal of Clinical Dermatology and Venereology. 2023;22(6): 693‑700

DOI: 10.17116/klinderma202322061693

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To cite this article:

Mardanly SG, Rogozhnikova EP, Rogozhnikov JA. Terbinafine hydrochloride — a drug with a wide range of antifugal protection. Russian Journal of Clinical Dermatology and Venereology. 2023;22(6):693‑700. (In Russ.)
https://doi.org/10.17116/klinderma202322061693

Подписка 2026 Клиническая дерматология и венерология (Russian Journal of Clinical Dermatology and Venereology)

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Abstract:

BACKGROUND

There is a need of development and registration of domestically produced medicines to replace expensive imported pharmaceuticals.

OBJECTIVE

«ECOlab» enterprise has developed and registered a full analogue of the Lamisil medical preparation («Novartis Pharma S.A.S», France), namely a spray of 1% terbinafine hydrochloride for external use.

MATERIAL AND METHODS

The spray preparation technology has been reproduced and the technology transfer to industrial production lines has been carried out. The product quality has been confirmed by validated methods of quantitative determination of the active substance, product-related impurities and alcohol. A validity period has been established and the necessary pre-clinical and clinical trials have been conducted.

RESULTS

All the measures for registration of the medical preparation terbinafine hydrochloride, 1% spray for external use of «EKOlab» enterprise have confirmed its effective therapeutic action and safety of use.

CONCLUSION

The marketing authorisation for the drug was obtained on the basis of opinion of an experts’ commission on the results of the drug quality expertise and the expected benefits expertise to the possible risk after checking the data completeness, presented in the registration file for the drug and the quality control of the preparation submitted for registration.

Keywords:

terbinafine hydrochloride

antifungal preparation

lamisil

Authors:

Mardanly S.G.

CJSC «EKOlab»;
State University of Humanities and Technology

ORCID: 0000-0003-3650-2363

Rogozhnikova E.P.

CJSC «EKOlab»;
State University of Humanities and Technology

ORCID: 0000-0002-8725-4673

Rogozhnikov J.A.

Military Academy of Radiation, Chemical and Biological Protection named after Marshal of the Soviet Union S.K. Timoshenko

ORCID: 0009-0006-0966-0912

Received:

07.08.2023

Accepted:

10.10.2023

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