Tim Freeman, Managing Director of Freeman Technology, discusses how to optimise granulation using real-time analysis in the latest edition of European Pharmaceutical Manufacturer.
High shear wet granulation (HSWG) transforms fine powder blends into free-flowing granules with improved compression properties during the tabletting process. Granulation also enhances the uniformity of a blend, increases density and reduces dust levels, an important health and safety benefit. The pharmaceutical industry is one of several which rely heavily on HSWG processes, most especially in the manufacture of oral solid dosage forms.
A Quality by Design (QbD) approach in drug development and manufacture relies on data collection at relevant points in the process to control the critical quality attributes (CQAs) of the product. Granules are typically an intermediate, rather than the end product, making it more difficult to identify the critical process parameters (CPPs) that impact the CQAs of the finished product.
Research has shown that HSWG processes can be successfully optimised using at-line techniques such as dynamic powder testing, but continuous, real-time analysis has the ability to provide further information by measuring the wet granulated mass, in-process, without interrupting the granulation operation.
The Lenterra Flow Sensor (LFS) System (Lenterra Inc. USA) is a Process Analytical Technology (PAT) that provides high frequency, high resolution in-line flow force measurement. This article looks at how it works and examines its potential application in HSWG monitoring and control, via an experimental study. Correlation of in-line data with results generated in the lab using an FT4 Powder Rheometer® suggests that both can be used at different stages of development and manufacturing to optimise HSWG processes.
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