DuraLac® H
Premium anhydrous beta-lactose – USP-NF, Ph. Eur., JP and ChP
Anhydrous lactose, such as DuraLac® H, is produced by roller-drying of a lactose solution at high temperatures, forming 70-80 % anhydrous beta-lactose crystals. With low hygroscopicity, it minimizes moisture uptake, making it ideal for moisture-sensitive APIs and ensuring long-term stability in pharmaceutical formulations. Its brittle fracture behavior during compaction provides excellent compactibility, supporting direct compression and dry granulation processes like roller compaction and slugging. Additionally, the optimized particle size distribution enhances powder flow, ensuring efficient tablet manufacturing. These properties make anhydrous lactose a versatile excipient for high-performance pharmaceutical applications.
DuraLac® H is produced by roller-drying of a lactose solution at high temperatures to form anhydrous beta-lactose and alpha-lactose crystals. During anhydrous lactose crystallization, no water is incorporated in the crystal lattice. Subsequent to roller-drying, anhydrous lactose is milled and sieved to the desired particle size distribution, optimizing powder flow and compactibility.
As DuraLac® H deforms by brittle fracture during compaction, it is well suited for directly compressed and dry granulated formulations (roller compaction, slugging).
Benefits
- Excellent compactibility
- High storage stability
- Very good recompactability
- Disintegration independent of compaction pressure
- Low water content
Areas of Application
- Direct compression
- Dry granulation (Roller compaction, slugging)
- Capsule filling and sachets
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- Direct compression
- Dry granulation
- Roller compaction
- Anhydrous Lactose
- Oral Solid Dose
- Placebo tablet
- Low dose DC formulation
- Capsule
- Sachet
- Tablet
25kg – Carton box with aluminium laminated inliner
36 months
Le Sueur/Minnesota, USA
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Typical particle size distribution
Typical Product Data
- x10: 18 µm, x50: 170 µm, x90: 344 µm
- Span [(x90-x10)/x50]: 1.97
- Density bulk: 0.710 g/ml
- Density tapped: 0.888 g/ml
- Hausner Ratio: 1.25
- Carr’s Index: 20 %
Specified Product Data
Particle size distribution
Sieve Method: Air-jet sieving
- <45 µm: NMT 20%
- <150 µm: 40-65%
- <250 µm: NLT 80%
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