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

摘要 这个应用程序的重点是，了解局部的成分差异的影响， 制剂，其物理和结构属性，并反过来，对患者的感知， 这可能与治疗效果有关。此外，产品老化对关键 Q3属性，可能反过来影响知觉将通过感官试验进行调查。 在此更新机会之前，我们已经生产了26种含有不同数量HEC的凝胶 CBP使用聚合物胶凝剂。Q2的进一步差异是通过改变 丙二醇和酒精含量，系统。这些产品广泛 其特征在于与关键感官知觉相关的Q3参数范围。一部分 在这个项目的更新中，我们将开始感官焦点小组评估。我们一直 成功获得我们当地IRB的伦理批准， 食品和药物管理局，准备进行试验。此次更新中包含的另一个新维度是测试 产品质量/结构属性以及不同主题的感官属性 在产品保质期内的预定时间点对产品进行检测。我们已经开发 仪器技术与稳健设计的方法作为我们目前工作的一部分， 可用于预测患者的感知/接受度。这些测试曾经与 感官小组测试和验证可能取代感官小组测试。这将 对行业有很大的好处。

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.