What techniques do you use to ensure the stability and efficacy of a new formulation?

Your Answer

How To Answer This Question?

This question is designed to evaluate your technical expertise and practical experience in formulation science. When answering, focus on specific techniques and methodologies you use to ensure stability and efficacy. Mention any relevant analytical methods, stability testing protocols, and quality control measures. Provide examples from your past experience where you successfully developed and tested a formulation, highlighting the techniques you used and the outcomes achieved.

For example:

"To ensure the stability and efficacy of a new formulation, I employ a combination of analytical techniques and stability testing protocols. I start with pre-formulation studies to understand the physicochemical properties of the active pharmaceutical ingredient (API). I use techniques such as High-Performance Liquid Chromatography (HPLC) and Differential Scanning Calorimetry (DSC) to analyze the stability of the API under various conditions. Additionally, I conduct accelerated stability studies following ICH guidelines to predict the shelf life of the formulation. Quality control measures, including regular testing and validation, are also integral to my process. In my previous role, I developed a new drug delivery system that maintained stability and efficacy over a two-year period, which was confirmed through rigorous testing and validation."