Stabilization of dithranol in topical formulations.

The influence of different factors such as drug concentration, temperature, pH value, humidity, solubility and stabilizers on the antipsoriatic drug dithranol in topical formulations has been investigated. Dithranol was examined in lipophilic, hydrophilic and cream bases under defined conditions. Additionally, stabilizers have been investigated to protect dithranol against degradation. The drug stability in the formulations was measured by a selective HPLC system. The results showed a strong dependency of the degradation on the drug concentration. The influence of temperature is not of the same importance. Besides the pH value also the type of puffer system must be considerated. The most important effect on dithranol stability which has been directed is the solubility of the drug substance in the ointment base. With higher solubility a significantly accelerated degradation occurs. Degradations of dithranol in hydrophilic and lipophilic bases can be reduced by different stabilizers. Among others succinic acid and tartaric acid being most effective.