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首页> 外文会议>Annual meeting exposition of the Controlled Release Society >Development of a New Diclofenac Sodium (DS) Patch (NAL1219):Study of Skin Permeation, Efficacy and Bioequivalence of NAL1219 to Voltaren® Tape
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Development of a New Diclofenac Sodium (DS) Patch (NAL1219):Study of Skin Permeation, Efficacy and Bioequivalence of NAL1219 to Voltaren® Tape

机译：新型双氯芬酸钠（DS）补丁（NAL1219）的开发：NAL1219与Voltaren®胶带的皮肤渗透性，功效和生物等效性研究

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A new diclofenac sodium (DS) patch (NAL1219) was developed and compared to a commercially available DS patch (Voltaren® Tape).To compare NAL1219 and Voltaren® Tape, an in-vitro human cadaver skin permeation study and an in-vivo pharmacokinetic (PK) study in hairless rat were conducted. The anti-inflammatory efficacy profiles of these two DS patches were also evaluated on carrageen-induced paw edema and on foot pressure pain induced by yeast-inflamed paws in rats (n=8). In addition, bioequivalence (BE) studies were performed in healthy human volunteers.The DS skin permeation profiles through human cadaver skin and the PK profiles of DS in hairless rat were comparable for NAL1219 and Voltaren® Tape. In efficacy studies, both products showed similar anti-inflammatory activity in rats. Human BE study indicated that NAL1219 patch was bioequivalent to Voltaren® Tape based on the bioequivalence criteria ranging from log(0.70)tolog(1.43).In conclusion, NAL1219 DS patch was successfully developed by showing the comparable anti-inflammatory efficacy profiles in rats and being bioequivalent to Voltaren® Tape in healthy human volunteers.
机译：开发了一种新的双氯芬酸钠（DS）贴剂（NAL1219），并将其与市售的DS贴剂（Tape Tape）进行了比较。 为了比较NAL1219和Tapetar，在无毛大鼠中进行了体外人体尸体皮肤渗透研究和体内药代动力学（PK）研究。还对角叉菜胶引起的爪水肿和酵母发炎的爪引起的足压痛的大鼠（n = 8）评估了这两种DS贴剂的抗炎功效。此外，在健康的人类志愿者中进行了生物等效性（BE）研究。 DS透过人体尸体皮肤的渗透曲线和DS在无毛大鼠中的PK曲线与NAL1219和Tape相当。在功效研究中，两种产品在大鼠中均显示出相似的抗炎活性。人类BE研究表明，根据生物等效性标准，从log（0.70）到log（1.43），NAL1219补丁与Voltaren®Tape具有生物等效性。 总之，通过在大鼠中显示出可比的抗炎功效概况并在健康人类志愿者中与Voltaren®Tape具有生物等效性，成功开发了NAL1219 DS贴剂。

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