Lactohale® 400

Anhydrous lactose

Coarse milled lactose

Irregular shaped particles

Inhalation
Lactohale 400 (1)

Product information

Lactohale® 400 is a milled, anhydrous lactose grade with a median particle size of 100μm. The coarse milled lactose grade could be used in Dry Powder Inhalation (DPI) applications where a relatively good flow with some cohesiveness is required. Its anhydrous nature makes this a unique product in our portfolio. Lactohale® 400 is produced in Borculo, the Netherlands.

The anhydrous nature of Lactohale® 400 differentiates this product from most commonly used lactose carriers in DPI formulations. Anhydrous lactose has a higher true density than lactose monohydrate. Additionally, particles typically have a greater roughness, due to the microcrystalline structure of beta lactose crystals. Anhydrous lactose can provide a different aerosolization performance than lactose monohydrate with the same particle size. This is due to the difference in interfacial properties, which mainly govern the fluidization and entrainment behaviour of the lactose. 

Product types
Milled lactose, Anhydrous lactose
Excipient functionality
Carrier
Dosage forms
Inhalation

Typical product data

Particle size distribution (μm)

D10
6
D50
102
D90
272

Bulk density (g/L)

Bulk density (g/L)
650

Tapped density (g/L)

Tapped density (g/L)
920

Carr’s index (-)

Carr’s index (-)
> 29

Documentation

  • ALBA Pharmaceutical lactose
  • Statement of business continuity planning
  • Genotoxic impurities statement
  • GMO Statement lactose
  • MSDS Anhydrous lactose
  • Nutritional information lactose
  • Compliance packaging
  • Shelf life statement lactose
  • GMP+ DMV - Fonterra Excipients B.V. Borculo
  • Halal DFE Pharma B.V. Borculo
  • ICHQ3D Elemental Impurities Inhalation Lactose - Lactohale® (EU)