LEVERAGING FIT TO PURPOSE DRUG RELEASE MODELS TO HELP WITH FORMULATION DEVELOPMENT AND SCALE-UP EFFORTS - poster
Ravichandra Palaparthi, PhD[a,b]
[a]Anagha Consultants, Hyderabad 500050 India, [b]Anagha Consultants LLC, Hockessin DE 19707, United States
The quality of a product produced from a process is dependent on how it is formulated (the ingredients, their composition), but also on the process conditions of production, and the characteristics of the equipment used. Understanding of the interaction of these different factors, in addition to how the ingredients of the formulation interact with each other is important to achieve a consistent product quality. This is especially true for the pharma and specialty materials industry, where consistently maintaining finished product quality is critical. Hence formulators need to account for these interactions early on in their formulation development efforts and ensure they go hand in hand with the process/scale-up ones. A combination of fit for purpose process and application specific models can be leveraged to get actionable insights into the necessary experimentation to meet drug product quality attributes.
This poster and video focus on an example case study in this direction from the pharma space of sustained release microspheres products. It shows how a model for drug release [1] can be leveraged to bring insights into necessary experimentation to troubleshoot issues with variability in finished product's drug release rates. Use of such customized application specific models along with process models can help provide predictability to (and address troubleshoot such issues during) scale-up. Such customized tools facilitate the scientists and engineers in the industry to effectively leverage the power of simulations in their routine needs.
1. Mehan, et al AIChE Annual Conference, 2016