Analysis of the temperature factor’s influence on the pharmacotechnological parameters of the experimental cream «myco-protection plus active» for local therapy of foot mycoses (in the context of medical support needs of the Armed Forces of Ukraine)
Introduction. The development of effective and stable creams for the treatment of foot mycoses is especially relevant for the needs of the Armed Forces of Ukraine, due to the specific conditions that promote the occurrence of these infections. Creams are the optimal dosage form for topical treatmen...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Ukrainian Military Medical Academy
2025-06-01
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| Series: | Український журнал військової медицини |
| Online Access: | https://ujmm.org.ua/index.php/journal/article/view/547 |
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| Summary: | Introduction. The development of effective and stable creams for the treatment of foot mycoses is especially relevant for the needs of the Armed Forces of Ukraine, due to the specific conditions that promote the occurrence of these infections. Creams are the optimal dosage form for topical treatment in field conditions, as they minimize systemic side effects and help preserve combat readiness. Studying the stability of the cream is critically important to ensure its efficacy and safety during long-term storage and use under challenging conditions, ultimately contributing to the rapid recovery of military personnel.
The purpose of the study is to detect the effects of heat treatment on the proposed formulation of the topical cream «Myco-Protection Plus Active», taking into account the temperature range typically used in the technological process of preparing emulsion systems.
Materials and methods. For the derivatographic analysis, the following were used: the experimental cream for topical treatment of foot mycoses, the emulsion-based carrier, and its individual components (glycerin, polyethylene glycol 400, sunflower oil, glyceryl stearate citrate, and PEG-100 glyceryl monostearate). Thermographic studies were conducted using a Shimadzu DTG-60 derivatograph (Japan) with a platinum–platinum-rhodium thermocouple. Samples weighing 16.22 to 57.01 mg were heated in aluminum crucibles from 25°C to 200°C at a rate of 10°C per minute, using α–Al₂O₃ as the reference standard. The data were recorded in the form of T (temperature), TGA (mass change), and DTA (thermal effects) curves, enabling thermogram evaluation.
Results. Thermal analysis data of the active pharmaceutical ingredient in the topical antifungal drug indicate that 2–(((3–(2-fluorophenyl)–5–mercapto–4H–1,2,4–triazol–4-yl)imino)methyl)phenol is a thermally stable compound within the temperature range of 18 to 198°C. The thermal behavior of the excipients used in the topical semisolid formulation also demonstrates relative thermal stability within the studied temperature interval. Derivatographic analysis of the emulsion-based carrier shows a notable mass loss occurring at temperatures above 60°C. For example, at the fifth minute of the experiment, a mass change of 1.31 mg (3.62%) was observed at 61.22°C. By the twelfth minute, at a temperature of 133.25°C, a distinct endothermic effect (–117.30 µV) was detected, with a total mass loss of 18.48 mg (51.0%) from the original sample. The thermal effects observed in the thermogram of the cream containing the active pharmaceutical ingredient and the placebo cream were identical and closely matched those of the individual excipient components, confirming the absence of interactions between the ingredients.
Conclusions. The study confirms the feasibility of producing the cream «Myco-Protection Plus Active» at temperatures up to 90°C without significant changes in its pharmacotechnological characteristics. Interactions between the active pharmaceutical ingredient and the excipients in the formulation of the topical antifungal agent were also identified.
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| ISSN: | 2708-6615 2708-6623 |