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      New approaches to identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms

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          Abstract

          Tioconazole (TCZ), a broad-spectrum antifungal agent, has significant activity against Candida albicans and other Candida species, and therefore, it is indicated for the topical treatment of superficial mycoses. The main goal of this work is to report an exhaustive identification and characterization procedure to improve and facilitate the online quality control and continuous process monitoring of TCZ in bulk material and loaded in two different dosage forms: ovules and nail lacquer. The methodologies were based on thermal (differential scanning calorimetry (DSC), melting point, and thermogravimetry (TG)), spectroscopic (ultraviolet (UV), Raman, near infrared (NIR), infrared spectroscopy coupled to attenuated total reflectance (FTIR-ATR), and nuclear magnetic resonance (NMR)), microscopic and X-ray diffraction (XRD). The TCZ bulk powder showed a high crystallinity, as observed by XRD, with a particles size distribution (3–95 µm) resolved by microscopic measurements. TCZ melting point (82.8 °C) and a degradation peak centered at 297.8 °C were obtained by DSC and DTG, respectively. An unambiguous structure elucidation of TCZ was obtained by mono- and two- dimensional 1H and 13C NMR spectral data analysis. The FTIR-ATR, Raman and NIR spectra of both the raw material and the commercial products were analyzed and their characteristic bands were tabulated. The best methods for TCZ identification in ovules were DSC, TG, XRD, NIR and Raman, while NIR and FTIR-ATR were the most appropriate techniques to analyze it in the nail lacquer. DSC, TG, DRX, Raman, FTIR-ATR and NIR spectroscopy are effective techniques to be used in online process analysis, because they do not require sample preparation, and they are considerably sensitive to analyze complex samples.

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          Most cited references 29

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          Application of the near-infrared spectroscopy in the pharmaceutical technology.

          Near-infrared (NIR) spectroscopy is currently the fastest-growing and the most versatile analytical method not only in the pharmaceutical sciences but also in the industry. This review focuses on recent NIR applications in the pharmaceutical technology. This article covers monitoring, by NIR, of many manufacturing processes, such as granulation, mixing or drying, in order to determine the end-point of these processes. In this paper, apart from basic theoretical information concerning the NIR spectra, there are included determinations of the quality and quantity of pharmaceutical compounds. Some examples of measurements and control of physicochemical parameters of the final medicinal products, such as hardness, porosity, thickness size, compression strength, disintegration time and potential counterfeit are included. Biotechnology and plant drug analysis using NIR is also described. Moreover, some disadvantages of this method are stressed and future perspectives are anticipated.
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            Onychomycosis.

            Onychomycosis is a frequent nail disease caused by dermatophytes, yeasts, and nondermatophyte molds. Trichophyton rubrum, T mentagrophytes, and Epidermophyton floccosum are the most common etiologic agents worldwide. Candida spp are the most frequent among the yeasts. Diagnosis is corroborated by direct microscopic examination, culture, and histomycology with periodic acid-Schiff stain. Other new methods of diagnosis are discussed. Treatment is based on oral antifungals: terbinafine, itraconazole, and fluconazole, including other emerging triazole drugs. Therapeutic outcome with ciclopirox and amorolfine lacquers alone and combined with systemic therapy are also reviewed, as well as the new nail enhancers and physical and chemical removal of the diseased nails. Copyright 2010 Elsevier Inc. All rights reserved.
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              Pharmaceutical counterfeiting.

              Pharmaceutical counterfeiting is becoming a serious problem both in developed and developing countries. This paper considers the extent of the problem and provides several examples of drugs which have been counterfeited. Additionally, the effects of counterfeit products on consumers, health care providers, drug manufacturers and governments are discussed. Several of the currently used methods of detection are described and these include near-infrared spectroscopy, Raman spectroscopy, isotopic characterization, tensiography, chromatographic and mass spectrometric approaches. Finally, anti-counterfeiting measures such as the use of holograms, tracers and taggants and electronic tracking are summarized.
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                Author and article information

                Affiliations
                [a ]Instituto de Química Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina
                [b ]Área Análisis de Medicamentos, Facultad de Ciencias Bioquímicas y Farmacéuticas, Universidad Nacional de Rosario, Suipacha 531, Rosario S2002LRK, Argentina
                [c ]Grupo de Materiales Compuestos Termoplásticos (CoMP), Instituto de Investigaciones de Ciencia y Tecnología de Materiales (INTEMA, CONICET-UNMdP), Colón 10890, Mar del Plata 7600, Argentina
                [d ]Área Técnica Farmacéutica, Facultad de Ciencias Bioquímicas y Farmacéuticas, Universidad Nacional de Rosario, Suipacha 531, Rosario S2002LRK, Argentina
                Author notes
                [* ]Corresponding authors at: Instituto de Química Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina. calvo@ 123456iquir-conicet.gov.ar leonardi@ 123456iquir-conicet.gov.ar
                Contributors
                Journal
                J Pharm Anal
                J Pharm Anal
                Journal of Pharmaceutical Analysis
                Xi'an Jiaotong University
                2095-1779
                2214-0883
                23 November 2018
                February 2019
                23 November 2018
                : 9
                : 1
                : 40-48
                6355464 S2095-1779(18)30251-X 10.1016/j.jpha.2018.11.006
                © 2018 Xi'an Jiaotong University. Production and hosting by Elsevier B.V.

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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