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Abstract：
The design and development of pharmaceutical products require specific knowledge, time, and investment. Response surface methodology (RSM) is a widely used technique in the design of experiments (DoE) to optimize various processes and products. The aim of this study was to model and produce experimental emulgels containing 1% ciclopirox olamine and to evaluate their physical, rheological, and mechanical properties and their ability to release ciclopirox olamine. The objective was to optimize the composition of the experimental emulgel containing 1% ciclopirox olamine by applying a central composite design based on selected criteria. The surfactant (polysorbate 80) had the greatest influence on the physical, rheological, and mechanical properties of the emulgels, as well as on the release of ciclopirox olamine from these systems. During the optimization process, an emulgel of optimal composition was generated containing 38.27% mineral oil, 6.56% polysorbate 80, and 55.17% hydrogel containing 1% ciclopirox olamine, meeting specified criteria (dependent variables) including the maximum flux of ciclopirox olamine, the minimum sol-gel transition temperature (Tsol/gel), and the minimum particle size of the oil phase. The oil phase particle size (D50) of this emulgel was determined to be 0.337 µm, the system Tsol/gel was 9.1 °C, and the flux of ciclopirox olamine from this gel matrix was calculated to be 1.44 mg/cm2. This emulgel of optimal composition could be used to treat fungal skin diseases.
摘要：
医药产品的设计和开发需要特定的知识，时间,和投资。响应面法（RSM）是实验设计（DoE）中广泛使用的技术，用于优化各种工艺和产品。本研究的目的是模拟和生产含有1％环吡罗明的实验乳液，并评估其物理，流变学,和机械性能及其释放环吡唑胺的能力。目的是通过基于所选择的标准应用中心复合材料设计来优化含有1%环吡罗胺的实验乳化凝胶的组成。表面活性剂(聚山梨酯80)对物理、流变学,以及乳液的机械性能，以及从这些系统中释放环吡酮醇胺。在优化过程中,产生了含有38.27％矿物油的最佳成分的乳化凝胶，6.56%聚山梨酯80和含有1%环吡罗胺的55.17%水凝胶，满足指定标准（因变量），包括环吡唑胺的最大通量，最低溶胶-凝胶转变温度（Tsol/gel），和油相的最小粒径。该乳液的油相粒径(D50)测定为0.337μm,系统Tsol/gel为9.1°C，并且计算出来自该凝胶基质的环吡酮醇胺的通量为1.44mg/cm2。该最佳组合物的乳液可用于治疗真菌性皮肤病。
