Comparative development and evaluation of topical gel and cream formulations of psoralen.

The aim of the present investigation is to develop topical gel and cream formulations of psoralen for enhancing its transport through the skin, with the goal to shorten the delay between drug application and UVA irradiation. In our first studies, oil-in-water (O/W) creams of psoralen (0.05% concentration) were prepared using Apifil (PEG-8 Beeswax) and Plurol Stearique WL 1009 as emulsifying agents and aqueous cream (British Pharmaceutical Codex) as the cream base material. In our second studies, hydroalcoholic transparent gel formulations of this drug in a 0.05% concentration were prepared using hydroxypropylcellulose (HPC) as the gelling agent. The physicochemical compatibility between psoralen and formulation excipients used in the cream and gel formulations was confirmed by using differential scanning calorimetry and Fourier transform infrared spectroscopy. All prepared cream and gel formulations were evaluated for drug content uniformity, viscosity, pH, stability, and limpidity. The release of psoralen from all formulations via dialysis through a cellulose membrane into phosphate buffer pH 6.8 at 37°C was studied. The penetration enhancing effect of menthol (0-12.5%, w/w) on the percutaneous flux of psoralen through excised rat epidermis from gel and cream formulations was also investigated. The release profile of psoralen from gel formulations was higher than that from cream formulations. The percutaneous flux and enhancement ratio of psoralen across rat epidermis was significantly enhanced by the addition of menthol in both gel and cream formulations as compared to gel and cream formulations prepared without menthol (p < 0.05).