Formulation of Triple Cream for Treatment of Melasma

Background: Melasma is a common disorder of hyperpigmentation affecting the face that is associated with considerable psychological impacts. The management of melasma is challenging and requires a long-term treatment plan. Therapeutic goals for hyperpigmentation include the destruction of melanosomes, inhibition of the melanocyte formation, and delay in the spread of melanocytes. Hydroquinone is a commonly used treatment for melasma, but it is combined with other medications due to its low efficacy in single therapy and relapse. Hydroquinone is hydroxy phenol which inhibits melanin by inhibiting tyrosinase. In addition, retinoid is effective in treating melasma and stimulate the cycle of skin cells, thus increasing the rate of loss of color pigmentation. A corticosteroid is used to increase the efficacy of these two drugs. Objectives: The purpose of this study is to formulate an integrated formulation for the treatment of this skin disease. Methods: The triple cream, which is a combination of hydroquinone (HQ), tretinoin (TRE), and fluocinolone acetonide (FLU) demonstrate better efficacy in decreasing skin pigmentation due to the additive and synergistic effects of these ingredients. As there is no topical generic formulation in combined form in Iran, such cream is prepared that contains 4% HQ, 0.05% TRE and 0.01% FLU as an oil in water (O/W) cream. Results: The result of this study was a 6-month accelerated evaluation of physical and physicochemical properties, including pH, electrical conductivity, density, viscosity, active ingredient identification, determination of amount and completely stable and homogeneous microbial tests. A review of the identification of the active ingredient and the determination of the amount conformed to the USP standard (American Pharmacopoeia). Also, material release from the base was well done. Conclusions: The prepared cream was completely stable and homogeneous during the accelerated conditions by evaluating of physicochemical and microbial assessments.