Levitt Jacob, Feldman Terry, Riss Ildiko, Leung On-Tai
Department of Dermatology, Mount Sinai Medical Center, New York, New York, USA.
J Drugs Dermatol. 2003 Dec;2(6):640-2.
The physical and chemical compatibility of desoximetasone ointment 0.25% and tacrolimus ointment 0.1%, both widely used to treat atopic dermatitis, were determined. A 1:1 (w/w) mixture of desoximetasone ointment 0.25% (Topicort, Taro Pharmaceuticals USA, Inc.) and tacrolimus ointment 0.1% (Protopic, Fujisawa Healthcare, Inc.) were prepared and stored under three different temperature/relative humidity conditions: 25 degrees C/60% RH; 30 degrees C/60% RH; and 40 degrees C/75% RH. Unmixed ointments stored under the same temperature and humidity conditions as the mixture served as controls. Samples were evaluated at days 1, 2, 7, 14, and 28 for color, degree of physical separation, and chemical stability via reverse-phase high performance liquid chromatography. Ranges of relative recovery for each active ingredient for all storage conditions ((% Mixture/% Control) x 100) were 89.6-109.3% for tacrolimus and 99.0-103.4% for desoximetasone. No significant difference in physical appearance or chromatographic profile between the mixture and controls was observed. Therefore, we conclude that desoximetasone ointment 0.25% (Topicort) and tacrolimus ointment 0.1% (Protopic) are physically and chemically compatible up to four weeks when mixed in a ratio of 1:1 (w/w).
测定了两种广泛用于治疗特应性皮炎的药膏,即0.25%的去氧米松药膏和0.1%的他克莫司药膏的物理和化学相容性。制备了0.25%去氧米松药膏(Topicort,美国塔罗制药公司)和0.1%他克莫司药膏(Protopic,藤泽医疗保健公司)1:1(w/w)的混合物,并在三种不同温度/相对湿度条件下储存:25℃/60%相对湿度;30℃/60%相对湿度;40℃/75%相对湿度。将在与混合物相同温度和湿度条件下储存的未混合药膏用作对照。在第1、2、7、14和28天通过反相高效液相色谱法对样品进行颜色、物理分离程度和化学稳定性评估。所有储存条件下每种活性成分的相对回收率范围((混合物%/对照%)×100),他克莫司为89.6 - 109.3%,去氧米松为99.0 - 103.4%。混合物与对照之间在外观或色谱图上未观察到显著差异。因此,我们得出结论,0.25%去氧米松药膏(Topicort)和0.1%他克莫司药膏(Protopic)以1:1(w/w)比例混合时,在四周内物理和化学性质相容。