Research Project
10374955
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.
