A Pilot Analysis of Morphometric Assessment of Itraconazole Brands Using Dermoscopy and its Relevance in the Current Scenario.

Background: Itraconazole (ITZ) is widely used for cutaneous and systemic mycoses. Its bioavailability is inconsistent and shows interindividual variations. The quality of ITZ pellets is an important factor determining its absorption profile and thereby the therapeutic effect. Analysis of morphometric characteristics is a surrogate method to determine the same. Pellet number and size are the most important parameters in this regard.

Aim: We aimed to delineate few low-cost brands, the assessed variables of which fell within the formulated criteria.

Materials and Methods: In all, 22 (100 mg) formulations of ITZ were included. The pellet number was calculated manually and pellet size was determined using a dermoscope with an inbuilt measurement tool. Furthermore, size variation with respect to the innovator US Food and Drug Administration (FDA)-approved brand was determined.

Results: There is a large variation in pellet number and average pellet size among different brands. Pellet number ranged from 121 to 820 and average size from 959 to 1845 μm. Few brands had dummy pellets and loose powder within the capsule. Two brands within the price range of less than Rs. 20 per capsule fulfilled the three formulated criteria: of a good pellet count, small pellet size, and low size variation. Two other brands also satisfied these criteria but were priced between Rs. 20 and 30 per capsule. The innovator US FDA-approved brand had the highest number of pellets and minimum size variation but is the costliest of all assessed brands.

Limitations of the Study: We cannot comment on inter-batch variation as ours was a one-point assessment. Advanced techniques such as scanning electron microscopy and drug release profile, which would have given further useful information on pellet quality, were beyond our scope.

Conclusion: There is marked variation in the assessed characteristics of ITZ formulations. These morphometric characteristics may have a significant bearing on the quality of ITZ. And thus analysis of these can help clinicians make an informed decision in choosing an ITZ formulation to achieve optimal efficacy.