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THE PHARMA REVIEW (MAY - JUNE 2013)

Optimizing Tabletting Processes with Quality by Design: An Overview

Pharm Nwoko Valentine. E

Introduction:
As the industry focuses on better manufacturing efficiency, there is greater interest in identifying powder properties that directly influence tabletting in-process performance and final product quality. Particle-size distribution is a critical primary particle characteristic of powders, but it is only one of many variables that impact bulk powder properties, which in turn dictate in-process behaviour and product quality. Bulk property measurements can be an efficient way of accelerating and supporting process optimization studies because they quantify the net effect of all primary particle properties (e.g., size, shape, texture, surface energy and porosity), whether these can be measured directly or not. Furthermore, even if all primary particle properties that influence in-process behaviour could be measured, the mathematical relationship between bulk powder behaviour and particle characteristics remains elusive and highly complex. Hence, the most effective way forward is to measure process relevant characteristics of the bulk powder.

 

 

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