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Formulation optimization and characterization of transdermal film of simvastatin by response surface methodology

机译：响应面法优化辛伐他汀透皮膜的配方及表征

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Matrix type of simvastatin transdermal film (SSTF) was developed with poly(vinyl alcohol) (PVA) and eudragit RL100 (EG) using response surface methodology (RSM) to investigate combined effect of the selected process variables like SS concentration, PVA:EG ratio and the dibutyl phthalate (DBT) concentration at different levels on dependent variables such as tensile strength and flux, with an aim to optimize a suitable combination of drug, polymer and plastirizer ratio. The study reveals that the effect of DBT concentration was highest on tensile strength, while SS concentration exhibited pronounced effect on SS flux through the abdominal skin of rat According to Derringer's desirability prediction tool, the composition of optimized film was found to be 2% of SS, 2:1 ratio of PVA:EG and 40% of DBT. Under these conditions, the SSTF exhibited a predicted value of tensile strength and flux of 11.871 MPa and 43.569 μg/cm~2/h, respectively. The in vivo hypolipidemic study conducted for 14 days in hyperlipidemia induced Sprague-Dawley rats reveals that the optimized SSTF exhibited significant lowering of blood lipid level. The absence of skin irritation indicates that the prepared film was safe and well tolerated as transdermal formulation. Thus, the film may serve as an alternative therapy to oral dosage form of SS.
机译：辛伐他汀透皮膜（SSTF）的基质类型是使用响应表面方法（RSM）与聚乙烯醇（PVA）和eudragit RL100（EG）一起开发的，以研究所选工艺变量（如SS浓度，PVA：EG比）的综合作用以及邻苯二甲酸二丁酯（DBT）浓度在不同水平上取决于相关变量，例如抗张强度和通量，目的是优化药物，聚合物和增塑剂比例的合适组合。研究表明，DBT浓度对拉伸强度的影响最大，而SS浓度对通过大鼠腹腔皮肤的SS通量表现出明显的影响。根据Derringer的合意性预测工具，发现优化膜的组成为SS的2％ ，PVA：EG的2：1比例和DBT的40％。在这些条件下，SSTF的抗张强度和通量的预测值分别为11.871 MPa和43.569μg/ cm〜2 / h。在高脂血症诱发的Sprague-Dawley大鼠中进行的体内降血脂研究持续14天，结果表明优化的SSTF可以显着降低血脂水平。没有皮肤刺激性表明，所制备的薄膜作为经皮制剂是安全的并且具有良好的耐受性。因此，该膜可以用作SS的口服剂型的替代疗法。

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