Sheffield Monohydrate 200 Mesh
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Lactose Monohydrate
Product Application: GranulationsProduct Certification: Gluten-free,Kosher
Pharmaceutical Category: Crystalline Monohydrate
Sheffield Monohydrate 200 Mesh is a crystalline alpha-monohydrate excipient from Kerry Pharmaceuticals. It is recommended for a medium/fine wet or dry granulation. Monohydrate Lactose is a disaccharide obtained from the whey fraction of milk, and consists of one glucose and one galactose moiety. Sheffield™ Brand Monohydrate Lactose, N.F. is a crystalline alpha-monohydrate anomer. This brand meets all requirements of the National Formulary as well as the European and Japanese Pharmacopeias.
Particle Size Curves of Sheffield Monohydrate 200 Mesh
Application Data Advantages
Lactose monohydrate is typically used for wet or dry granulation. Granulation of crystalline monohydrate lactose is used to optimize particle size (for flowability) and compaction properties. The following study was performed to show an example of crystalline lactose properties before and after granulation.
Wet Granulation Formula
| Ingredient | Percent |
| Crystalline Lactose Monohydrate | 88 |
| Microcrystalline Cellulose | 5 |
| Povidone | 5 |
| Crospovidone | 2 |
Flowability
| Product | Angle of Repose (α) | Compressibility (Carr’s Index) | Flowability (g/sec) |
| Crystalline | 55 | 34 | 1.0 |
| Granulation | 47 | 18 | 4.5 |
Particle Size and Flowability
Advantages of Sheffield Monohydrate 200 Mesh
- Inert material, high purity, low colour
- Moisture stable – 4 year shelf life
- Physically and chemically stable
- High degree of crystallinity, low amorphous content
Lactose monohydrate is typically used for wet or dry granulation. During wet granulation, liquid binders or adhesives are added to the lactose and active mixture, usually by blending. The mixture is then dried and sized, and compressed into tablets. During dry granulation, the particle size is enhanced by aggregating the particles by roller compaction and then milling to the desired size.
