The objectives of this study were to measure the physicochemical properties of miconazole nitrate (MCZ: one brand name (MCZ-A) and three generics (MCZ-B, -C and - D)) creams, to conduct human sensory tests on such creams. The flattening, viscoelasticity, and water content of each cream were measured, and each cream was subjected to near-infrared (NIR) absorption spectroscopy and sensory testing. The yield value was calculated based on the measured flattening and was 734.8 dynes/cm2 for MCZ-A, 1198.9 dynes/cm2 for MCZ-B, 461.3 dynes/cm2 for MCZ-C and 3112 .3 dynes/cm2 for MCZ-D. Measurement of viscoelasticity and viscosity revealed that MCZ-C had a lower tanδ than the other 3 creams at 25ºC. NIR absorption spectroscopy revealed that MCZ-A had the highest absorption peak due to hydroxyl groups, followed by MCZ-C, -B, and then -D. Measurement of water content revealed that MCZ-A had a water content of 65.9%, MCZ-B, -C and -D had a water content of approximately 56.3%. Sensory testing in humans revealed differences between MCZ-A and MCZ-C and between MCZ-B and MCZ-D in terms of spreadability and sensation. These results indicate that differences in water and oil content and emulsification led the creams to have different physical properties, such as flattening, internal structure, and dynamic viscoelasticity. NIR absorption spectroscopy, which allows non-destructive measurement of the physicochemical properties of a sample, and viscoelasticity and viscosity measurement, which allows measurement of the dynamic viscoelasticity of a sample, revealed differences in the physical properties of the creams. Keywords: miconazole, spreadability, near infrared, sensory test, physicochemical properties IntroductionProviding safe and effective drugs to the individual patient...... middle of paper......c viscosity in particular is an important component of the association between physicochemical properties and sensation. Furthermore, creams mainly consist of additives, so a preparation can be significantly influenced by additives. In studies on ACV and TA, this laboratory compared preparations with different additives. However, no studies have compared the characteristics of preparations with the same types of additives, and no studies have examined the physical and tactile properties. The present study evaluated the physicochemical properties of MCZ creams with the same additives. The creams were also compared in human sensory tests. As reported here, the results provided information that allows the selection of a preparation in accordance with patient preferences and the intent of the prescriber without previously requiring the use of the preparation in a clinical context.
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