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In the present study the International Conference on Harmonization-prescribed stress degradation was carried out to study the degradation profile of edaravone. To establish a Quality by Design (QbD)-assisted stability-indicating assay, the reaction solutions in which different degradation products were formed were mixed. Plackett Burman and central composite design were used to screen and optimize experimental variables to resolve edaravone and its impurities with good peak symmetry using an RP C18 column. The method was validated according to International Conference on Harmonization guidelines. Seven unknown and two known degradation products were identified and characterized by LC-MS/MS. Two major degradation products formed under thermal degradation were isolated and characterized as 4-(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl-4-(4,5-dihydro-5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-yl)-3-methyl-1-phenyl-1H-pyrazol-5(4H)-one and 3-hydroxy-dihydro-thiazolo[1-(2-methyl-buta-1,3dienyl)-1-phenylhydrazine]5-one. The degradation pathways of degradants were proposed based on m/z values.
Assuntos
Antipirina/análogos & derivados , Antipirina/análise , Antipirina/química , Antipirina/isolamento & purificação , Cromatografia Líquida/métodos , Contaminação de Medicamentos , Estabilidade de Medicamentos , Edaravone , Limite de Detecção , Modelos Lineares , Reprodutibilidade dos Testes , Espectrometria de Massas em Tandem/métodos , TemperaturaRESUMO
In order to cure a range of ailments, scientists have investigated a number of bioactive antioxidant compounds produced from natural sources. Mangiferin, a C-glycosyl xanthone-structured yellow polyphenol, is abundant in mangoes and other dietary sources. In-depth examinations found that it is effective in the treatment of a variety of disorders due to its antiviral, anti-inflammatory, antiproliferative, antigenotoxic, antiatherogenic, radioprotective, nephroprotective, antihyperlipidemic, and antidiabetic properties. However, it is recognised that mangiferin's poor bioavailability, volatility, and limited solubility restrict its therapeutic usefulness. Over time, effective solutions to these problems have arisen in the shape of effective delivery methods. The current articles present a summary of the several researches that have updated Mangiferin's biopharmaceutical characteristics. Additionally, strategies for enhancing the bioavailability, stability, and solubility of this phytodrug have been discussed. This review provides detailed information on the development of innovative Mangiferin delivery methods such as nanoparticles, liposomes, micelles, niosomes, microspheres, metal nanoparticles, and complexation, as well as its therapeutic applications in a variety of sectors. This article provides effective guidance for researchers who desire to work on the formulation and development of an effective delivery method for improved magniferin therapeutic effectiveness.
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Natural polysaccharides have been widely exploited in drug delivery and tissue engineering research. They exhibit excellent biocompatibility and fewer adverse effects; however, it is challenging to assess their bioactivities to that of manufactured synthetics because of their intrinsic physicochemical characteristics. Studies showed that the carboxymethylation of polysaccharides considerably increases the aqueous solubility and bioactivities of inherent polysaccharides and offers structural diversity, but it also has some limitations that can be resolved by derivatization or the grafting of carboxymethylated gums. The swelling ratio, flocculation capacity, viscosity, partition coefficient, metal absorption properties, and thermosensitivity of natural polysaccharides have been improved as a result of these changes. In order to create better and functionally enhanced polysaccharides, researchers have modified the structures and properties of carboxymethylated gums. This review summarizes the various ways of modifying carboxymethylated gums, explores the impact that molecular modifications have on their physicochemical characteristics and bioactivities, and sheds light on various applications for the derivatives of carboxymethylated polysaccharides.
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Over the past few decades, natural gums are extensively investigated by the researchers due to their beneficial physicochemical properties. Among them, the polysaccharide exudates obtained from the stem of the plant Moringa oleifera, known as moringa gum, is investigated widely in the food, pharmaceutical, and other areas. The moringa gum is used in the form of dried powder as a pharmaceutical excipient in various formulations. It is also derivatized either by grafting or by other chemical modifications for enhancing its properties. The research on moringa gum and modified moringa gum has diversified in numerous biomedical fields. However, summarization of these progress are not available in the literature. This article gives an overview of the collection, purification, structural elucidation, and modification of moringa gum. Moreover, the present review furnishes complete information on the various aspects of moringa gum and its applications in various industrial and biomedical fields.
Assuntos
Portadores de Fármacos/química , Química Verde , Moringa/química , Gomas Vegetais/química , Polímeros/químicaRESUMO
The present study focus on ICH prescribed stress degradation of ciclopirox olamine after precolumn derivatization. For establishing stability-indicating assay, the reaction solutions in which different degradation products were formed were mixed, and the separation was optimized by applying principle of QbD. A risk-analysis tools based on cause-effect risk assessment matrix with control-noise-experimentation (CNX) approach was utilized for identifying the high risk variable affecting the analytical attributes. Plackett Burman and central composite design was then used to screen and optimize experimental variables for DOE studies to resolve ciclopirox olamine and four of its degradation related impurities with good peak asymmetry and theoretical plates using C18 column. The method was validated according to ICH and ISO guidelines. To ensure reliability of the result, evaluation of risk profile, combined standard uncertainty and expanded uncertainty were also studied. One process related and four unknown degradation products were identified and characterized by LC-MS/MS study. The degradation pathways of degradants were proposed based on m/z values.