Beads and beyond: An observational study to generate real world evidence on various brands of itraconazole

Abstract

Background: Rising number of the nonresponding dermatophytic infections raises deep concerns among the dermatologists across the nation. Variations in the quality of itraconazole may be a contributing factor to nonresponse in certain dermatophytic infections. This article will address this issue in a simple way of analyzing things in an OPD and may help us in being aware and taking the right foot forward. Aims and Objectives: To assess the quality of itraconazole brands by observing the morphological properties of pellets/beads in different brands. Methods: In this study, 10 brands of itraconazole that are commonly used in clinical practice were randomly selected. Pellet counts and qualitative morphological analysis of pellets as size (small, large, or mixed), shape (uniform or nonuniform), and presence of amorphous material was performed by three independent observers. Also, dissolution profile of some brands was assessed by adding the pellets in equal quantity of water. Results: The pellet counts of brands varied from 856 pellets per capsule in brand 1 to 109 pellets per capsule in brand 8. Brand 1, brand 2, and brand 7 pellets were small and uniform in morphology. Brand 3, brand 4, and brand 10 pellets were mixed in size but uniform in morphology. Brand 9 pellets were mixed and nonuniform whereas brand 5, brand 6, and brand 8 pellets were mixed in size, nonuniform in shape, and had presence of amorphous material. Dissolution test revealed that brand 5 dissolved rapidly and turned clear water color to milky white. Conclusion: A simple dermoscopy examination of itraconazole pellets may provide thoughtful insights about the quality of itraconazole brand. It may be considered as routine practice for all dermatophytic infection planned for treatment with itraconazole.

Keywords

• dermatophytosis
• dermoscopy
• generic
• innovator
• itraconazole
• pellet