Demonstration of the Biphasic Release of 0.1% Halcinonide Cream

January 2015 | Volume 14 | Issue 1 | Editorials | 89 | Copyright © January 2015

Zoe Diana Draelos MD

Department of Dermatology, Duke University School of Medicine, Durham, NC

Abstract
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.

INTRODUCTION

Frequency of dosing of any pharmaceutical product depends on its half-life—the shorter the half-life, the more frequent the dosing. Although longer half-lives can impact safety and adverse effects, they may have the advantage of improved patient compliance. In the case of topical products, which usually require rubbing into the skin, the length of effectiveness becomes important between applications.

METHODS

RESULTS