Elucidating the Sensorial and Functional Characteristics of Compositionally Different and Differently Aged Topical Formulations

摘要 这一应用的重点是，理解主题中成分差异的影响 配方，根据它们的物理和结构属性，反过来，根据患者的感知， 这可能与治疗效果有关。此外，产品老化对关键技术的影响 Q3可能反过来影响知觉的属性将通过感官试验进行调查。 在这次更新机会之前，我们已经生产了26种含有不同量HEC的凝胶 而CBP使用的是一种聚合物胶凝剂。第二季度的进一步差异是通过变化引入的 丙二醇和酒精含量，系统。这些产品被广泛地 以与关键感官知觉相关的一系列Q3参数为特征。作为一部分 在此次项目续签中，我们将启动感官焦点小组评估。我们一直在 成功获得我们当地IRB的道德批准，并从 FDA，为试验做好准备。此次续订中包含的另一个新维度是测试 不同主题的产品质量/结构属性以及感官属性 在产品保质期内的预定时间点的产品。我们已经开发出 乐器技术和稳健设计的方法作为我们当前工作的一部分，这是 可用于预测患者的感知/接受程度。这些测试曾经与 感官面板测试和验证可能会取代感觉面板测试。这将会 对这个行业大有裨益。

Abstract The focus of this application is, to understand the impact of compositional differences in topical formulations, on their physical and structural attributes, and in turn, on a patient's perception, which may be linked to therapeutic effect. Additionally, the impact of product ageing on critical Q3 attributes that may in turn affect perception will be investigated through sensorial trials. Prior to this renewal opportunity, we have manufactured 26 gels with different amounts of HEC and CBP used a polymeric gelling agents. Further Q2 differences were introduced by varying propylene glycol and alcohol content, systematically. These products were extensively characterized for a range of Q3 parameters that relate to key sensorial perceptions. As a part of this project renewal, we will start sensorial focus group evaluations. We have been successful at gaining ethics approval from our local IRB and a non-involvement status from FDA, in readiness for the trials. An additional new dimension included in this renewal is, testing the product quality/structural attributes as well as sensory attributes on different topical products at predetermined time points during a product’s shelf life. We have developed instrumental techniques with robustly designed methods as a part of our current work, which can be used to predict patient perception/acceptance. These tests once compared against sensory panel test and validated could potentially replace sensory panel testing. This would be immensely beneficial to the industry.