Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jan 30:555:337-345.
doi: 10.1016/j.ijpharm.2018.11.059. Epub 2018 Nov 22.

A big data approach to pharmaceutical flow properties

Andrew J Megarry  1 , Sadie M E Swainson  2 , Ron J Roberts  3 , Gavin K Reynolds  3
Affiliations

A big data approach to pharmaceutical flow properties

Andrew J Megarry et al. Int J Pharm. .

Abstract

Flowability is a key consideration during the formulation and process development of oral solid dosage forms as it can have a critical impact on product quality. With a limited number of examples available in the literature, there is a need to better understand and share the typical flow properties of pharmaceutical materials. Here, historical data (3909 experiments) from a shear cell apparatus were extracted and analysed. These data were composed of different material types, including APIs, excipients, blends and granules from nearly a decade of development projects. APIs were found to have poor flow properties (ffc <2), while other materials (excipients, blends and granules) generally had good flow properties. This analysis provided an enhanced understanding of the typical flow properties of pharmaceutical materials. By combining these data with information on the process and achieved drug load, it was possible to characterise our current operating space as a process flow map which could be used to focus future development.

Keywords: Formulation design; Oral solid dosage forms; Powder flow; Process development; Shear cell.

PubMed Disclaimer

MeSH terms