When working with powders, in-process performance and final product quality will be influenced by properties of the raw materials delivered to the process. The ability to control these raw materials, and therefore reliably predict process performance, is essential to ensuring the properties and quality of the final product. A method of accurately measuring process-relevant properties of incoming raw materials is therefore highly beneficial to a wide range of applications in various industries.
This application note, ‘The Influence of Storage and Handling’, considers the evaluation of bulk excipients for tableting and the impact of storage and handling conditions. In the study, Sorbitol was used as the bulk excipient in production of a tablet. The tablet manufacturer experienced variation in final product quality when using two batches of sorbitol that had previously been categorised as identical by the supplier. Tablets produced from one batch were consistently softer and less stable than those from the other batch. Following further investigation at the customer’s request, the excipient supplier was unable to differentiate between the batches using techniques they had available.
The only difference identified recorded about the batches was the location in which they had been stored before being supplied to the customer: the well-performing batch was stored in a silo close to the loading area (Silo 1), and the poorly-performing batch in a Silo further away (Silo 2), necessitating additional conveyance prior to processing.
Samples from both batches were analysed using an FT4 Powder Rheometer®.
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