Center for Dermatology and Laser Surgery, Columbia University, Sacramento, CA, USA.
Department of Dermatology, Henry Ford Hospital, Detroit, MI, USA.
J Dermatolog Treat. 2021 Jun;32(4):391-398. doi: 10.1080/09546634.2019.1668907. Epub 2019 Sep 26.
Successful clinical data on halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis are published. This article charts its formulation development.
Dermal deposition, clinical efficacy, and synergistic effect of HP and TAZ delivered by polymeric emulsion technology was compared to HP 0.05% cream (Ultravate) and TAZ 0.1% cream (Tazorac); skin hydration and barrier maintenance with vehicle lotion through Trans Epidermal Water Loss (TEWL) and corneometry using human cadaver tissue; and steroid potency by vasoconstrictor assay (VCA) in healthy volunteers. Safety and tolerability evaluated in clinical studies and patient preference questionnaire.
HP/TAZ lotion, using polymeric emulsion technology demonstrated better active ingredient delivery than HP 0.05% or TAZ 0.1% creams; supported by synergistic clinical data, with high HP potency outcome. Efficacy was rapid and sustained posttreatment. Layering TAZ 0.1% cream onto HP 0.05% cream had a negative effect on receptor phase levels. HP/TAZ lotion provided rapid and sustained increases in skin moisturization and gradually decreases in TEWL. Most subjects responded favorably to questions on the physical attributes of the vehicle lotion.
Fixed combination HP 0.01%/TAZ 0.045% lotion formulation utilizing innovative polymeric emulsion technology and optimal selection of solvents/emollients/humectants, has recently been developed. Features inherent in technology translate into rapid, sustained efficacy, low irritation, and good patient acceptance.
已发表有关卤倍他索丙酸 0.01%/他扎罗汀 0.045%（HP/TAZ）洗剂治疗中重度斑块型银屑病的临床成功数据。本文介绍了其制剂开发过程。
通过聚合物乳液技术比较 HP 和 TAZ 的经皮沉积、临床疗效和协同作用，与 HP 0.05%乳膏（Ultravate）和 TAZ 0.1%乳膏（Tazorac）进行比较；通过经表皮水分丢失（TEWL）和使用人体尸体组织的皮肤角质层测量仪评估载剂乳液对皮肤水合作用和屏障维持的影响；通过血管收缩剂测定（VCA）在健康志愿者中评估皮质类固醇的效价。在临床研究和患者偏好问卷中评估安全性和耐受性。
使用聚合物乳液技术的 HP/TAZ 洗剂显示出比 HP 0.05%或 TAZ 0.1%乳膏更好的活性成分传递效果；通过协同临床数据支持，具有高 HP 效价结果。治疗后疗效迅速且持续。在 HP 0.05%乳膏上分层涂抹 TAZ 0.1%乳膏会对受体相水平产生负面影响。HP/TAZ 洗剂可迅速且持续增加皮肤保湿，逐渐降低 TEWL。大多数受试者对载剂洗剂的物理特性问题做出了积极的回应。
最近开发了一种利用创新的聚合物乳液技术和最佳选择溶剂/赋形剂/保湿剂的固定剂量组合 HP 0.01%/TAZ 0.045%洗剂配方。技术固有的特点转化为快速、持续的疗效、低刺激性和良好的患者接受度。
