Demonstration of the Biphasic Release of 0.1% Halcinonide Cream

Halcinonide in Halog Cream is formulated in a unique cream base that allows a biphasic release of this Class II steroid. Halcinonide in this product exists in two phases—a solution phase that is released immediately and a suspension phase that has a delayed release over time. The goal of this study was to evaluate this biphasic release of halcinonide into the skin using a novel noninvasive method.
A dermal tape stripping protocol was used to quantify halcinonide concentration at 6 sequential depths in the skin of 4 sites on the forearms of 5 subjects. D-Squame strips were sequentially applied with consistent pressure and removed at 1, 3, 6, and 9 hours after application of halcinonide. Halcinonide was extracted from the strips and quantified using liquid chromatography mass spectrometry.
The highest concentration of halcinonide was detected in strip 1 from the superficial stratum corneum with subsequent reduction in deeper stratum corneum layers as expected. The concentration increased beyond the first hour after application and demonstrated a sustained release into hour 6 before beginning declining. Similarly, the average concentration of halcinonide in strips 1 to 6 peaked at hour 1 and remained elevated for 6 hours.
Data collected from the tape strips demonstrated a biphasic release of halcinonide—immediate release within 1 hour of application from the solution phase and continued, sustained release from the suspension phase following the first hour of application.