| Summary: | The aim of this study was to develop a lactose excipient using a production-scale roller compactor suitable for
use in the pharmaceutical industry. The physical properties and compression behavior of the roller compacted
lactose were investigated using Kawakita analysis and force-displacement (F-D) techniques. α-lactose monohydrate and spray dried lactose were used for comparison purposes. Kawakita analysis of the aforementioned powders showed that roller compaction produced lactose powder with characteristics similar to those of spray dried lactose with some additional improvements. Compression and profile analysis of the F-D curve confirmed that the roller compacted lactose has similar flow behavior to spray dried lactose with the advantage of a lower level of compression energy. Drug preparations utilizing compacted lactose showed no effect, for example hindering, on drug dissolution. Consequently, using industrial scale roller compactor is suitable to turn α-lactose monohydrate into a direct compression (DC) excipient equivalent to spray dried lactose. This outcome can be accomplished in the context of in-house and commercial processing of lactose products.
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