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Development and validation of a Stability-Indicating method for fenticonazole in a cream formulation.

Grant number: 12/19126-1
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): November 01, 2012
Effective date (End): July 31, 2013
Field of knowledge:Health Sciences - Pharmacy - Medicines Analysis and Control
Principal researcher:Hérida Regina Nunes Salgado
Grantee:Thais Araujo Silva
Home Institution: Faculdade de Ciências Farmacêuticas (FCFAR). Universidade Estadual Paulista (UNESP). Campus de Araraquara. Araraquara , SP, Brazil

Abstract

The fenticonazol [(RS) -1 - [2 - (2,4-dichlorophenyl) -2 - [4 - (fenitil) phenyl-methoxy] ethyl-1H-imidazole] is an imidazole derivative with topical antifungal activity which can be obtained from primary and secondary metabolism of microorganisms (fermentation). Displays chirality and is commonly marketed as a racemic mixture, being presented as nitrate fenticonazol. In therapy, is often used in cases of candidiasis, especially vaginal, dermatophytosis, ptiriasis versicolor and other cutaneous mycoses. Their antifungal activity is described by its action mechanism, since by inhibiting the cytochrome P450 enzyme, synthesis of ergosterol present in the plasma membrane of fungi is impaired and hence the growth and development of these as well. One of the important features needed for a drug or pharmaceutical product is that it remains stable, ensuring efficacy and safety until the time of use. Pharmaceutical products are very sensitive to variations in environmental conditions such as temperature, light and humidity, and their behavior to these factors is dependent on its physical and chemical characteristics of the active ingredient and excipients forming the pharmaceutical formulation, requiring the development of a method that allows the identification and verification of the performance of the product against these conditions in order to evaluate possible changes that may compromise the efficacy and / or safety of products. There is no indication of stability study published in international journals or official compendia for fenticonazol. Thus, this project has as main objective to generate new results to the scientific community, innovating from a study yet conducted to date, the development and validation of stability indicating analytical method for fenticonazol using HPLC.

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