Events

Dec 28, 2020

Abstract


EXAMPLE PROCESS CHALLENGES IN NANOSUSPENSION FORMULATIONS AND APPLICATIONS - poster

R Palaparthi1,2, Barnamala Saha3

1 Anagha Consultants, Bhagyanagar 500050, INDIA

2 Anagha Consultants LLC, Hockessin DE, USA

3 Amity School of Engineering and Technology, Amity University Haryana, INDIA

Contact Email: rpalaparthi@anagha.consulting

Specialty inks and some niche pharma formulations can be presented in the form of suspensions of nano particles. When they are prepared in a top down approach, larger size particles are milled to the required size using appropriate energy input, in the presence of surfactants for surface stabilization. Such suspensions are either used as is or subjected to downstream process steps for use in final applications. Characteristics like particle size distribution, shelf-life, and rheology impact their performance during the end-use. For a given chemistry, the preparation method of the suspension, batch sizes, and the conditions of the downstream process steps can significantly impact the performance of the finished products.

This poster discusses a couple of example challenges faced in a real-world scenario related to getting a reproducible nanosuspension product at one scale and scaling it up. It shows how structured approaches characterizing the materials, process, and understanding the underlying materials-process interactions, help address these challenges and achieve consistency in the finished product performance. Attention to such details during early stages of process development in an industry can result in significant cost-savings downstream.

Abstract

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 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 focuses 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

Two lectures delivered to graduate students in the M.E (Pharma) at NIPER Hyderabad, India during Apr, 2020