The Physicochemical Properties of Miconazole Nitrate

The aims of this study were to measure the physicochemical properties of miconazole nitrate (MCZ : a brand-name (MCZ-A) and three generic (MCZ-B, -C, and -D)) creams, to conduct human sensory testing of those 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 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 smaller 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 around 56.3%. Human sensory testing revealed differences between MCZ-A and MCZ-C and between MCZ-B and MCZ-D in terms of spreadability and feel. These findings indicate that differences in water and oil content and emulsification resulted in the creams having different physical properties, such as flattening, internal structure, and dynamic viscoelasticity. NIR absorption spectroscopy, which allows non-destructive measurement of a sample’s physicochemical properties, and measurement of viscoelasticity and viscosity, which allows measurement of a sample’s dynamic viscoelasticity, revealed differences in the physical properties of creams.

Keywords: miconazole, spreadability, near-infrared, sensory test, physicochemical propertie

Introduction

Providing safe and effective drugs to individual patien...

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...c viscosity in particular is an important component of the association between physicochemical properties and feel.

In addition, creams consist mainly of additives, so a preparation can be greatly affected by additives. In studies of 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 physical properties and feel.

The current study assessed the physicochemical properties of MCZ creams with the same additives. Creams were also compared in human sensory tests. As reported here, findings provided information that allows selection of a preparation in accordance with a patient’s preferences and the intent of the prescribing physician without requiring use of the preparation in a clinical setting beforehand.