Reddi Flo AG
D-Glucose, 4-O-β-D-galactopyranosyl-, hydrate (1:1)Product Application: Capsule filling,Direct Compression of Tablets,Direct tableting
Pharmaceutical Category: Agglomerated,Crystalline Monohydrate
Reddi Flo AG is an agglomerated crystalline lactose used in direct tableting operations. Applications that benefit from Reddi Flo are: direct compression of moisture sensitive actives with low dose/high potency APIs, harge gelatin capsule filling, whenever flowability is a concern or high volume throughput is needed.
Why do we need an agglomerated monohydrate lactose? Standard crystalline monohydrate lactose is not very compressible, and typically has poor flow properties; which makes them a poor choice for direct tableting manufacturing techniques. For optimal tableting characteristics of monohydrate lactose, there needs to be balance struck to provide good powder flow properties, requiring fine particles of lactose (to increase surface area); and coarser lactose particles to provide good flow characteristics. Spray dried versions of monohydrate lactose have been used for many years, because it combines crystalline and amorphous lactose in a unique balance, to create excellent flow, and good compressibility. However, the presence of amorphous lactose, can also create some issues with tablet stability, depending on the API properties and drug loading in the finished dose.
In addition to the size distribution of the lactose crystals, the morphology of the lactose plays a influential role regarding powder flow properties. As you can see on the next page, Reddi Flo AG has a unique morphology where the smaller lactose particles are attached, or bonded, to the coarser ones, to create a free flowing lactose powder. This bonding between lactose particles of different sizes, is the result of the carefully controlled spray agglomeration process, that removes the water bridge, at a very precise rate of evaporation.
Reddi Flo AG has excellent flow properties. Typically, this lactose will have a Carr’s index of approximately 14, which is an indicator of good flowability. It is slightly coarser than other modified monohydrate crystalline grades of lactose. This is due to the agglomerated nature of the product, as well as its unique morphology.
Some applications that would benefit from using Reddi Flo Ag would be:
- Direct compression of moisture sensitive actives, with low dose / high potency API’s
- Hard gelatin capsule filling
- Formulations that would otherwise require other excipients to attain desired compaction
- Whenever flowability is a concern or high volume throughput is needed